Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines
Official Title
A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Jul 8, 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 28, 2021Actual
Primary Completion Date
Jun 16, 2023Actual
Completion Date
Jun 16, 2023Actual
First Submitted Date
May 13, 2021
First Submission Date that Met QC Criteria
May 13, 2021
First Posted Date
May 17, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jun 13, 2024
Results First Submitted that Met QC Criteria
Nov 20, 2024
Results First Posted Date
Dec 11, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 3, 2025
Last Update Posted Date
Apr 20, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
A phase 1/2, open-label clinical trial in individuals, 18 years of age and older, who are in good health, have no known history of Coronavirus Disease 2019 (COVID-19) or Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, and meet all other eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of a delayed (>/=12 weeks) vaccine boost on a range of Emergency Use Authorization (EUA)-dosed COVID-19 vaccines (mRNA-1273, and mRNA-1273.211 manufactured by ModernaTX, Inc.; BNT162b2 manufactured by Pfizer/BioNTech; or Ad26.COV2.S manufactured by Janssen Pharmaceuticals/Johnson & Johnson). This is an adaptive design and may add arms (and increase sample size) as vaccines are awarded EUA and/or variant lineage spike vaccines are manufactured or become available. Enrollment will occur at up to twelve domestic clinical research sites.
This study includes two cohorts. Cohort 1 will include approximately 880 individuals (50 subjects/group; Groups 1E-11E) greater than 18 years of age and older, stratified into two age strata (18-55 years and >/=56 years) who previously received COVID-19 vaccine at Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100 mcg dose, two vaccinations of BNT162b2 at the 30 mcg dose, or one vaccination of Ad26.COV2.S at the 5x10^10 vp dose). Groups 15E-17E will enroll 60 subjects, split (approximately evenly) between age strata as able. Those subjects will be offered enrollment into this study >/=12 weeks after they received the last dose of their EUA vaccine. Subjects will receive a single open-label intramuscular (IM) injection of the designated delayed booster vaccine and will be followed through 12 months after vaccination: 1) Group 1E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp followed by a 100-mcg dose of mRNA-1273, Group 4E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp followed by a 5x10^10 vp dose of Ad26.COV2.S, Group 7E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S 5x10^10 vp followed by a 30-mcg dose of BNT162b2, Group 10E - previously EUA-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp followed by a 100-mcg dose of mRNA-1273.211; Group 12E - previously EUA-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp followed by a 50-mcg dose of mRNA-1273; Group 15E - previously EUA-dosed vaccination with Janssen (two doses for Group 15E) - Ad26.COV2.S at 5x1010 vp followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV-2 rS vaccine with 50 mcg Matrix-M); 2) Group 2E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 100-mcg dose of mRNA-1273, Group 5E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 5x10^10 vp dose of Ad26.COV2.S, Group 8E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 30-mcg dose of BNT162b2, Group 13E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 50-mcg dose of mRNA-1273; Group 16E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV2 rS vaccine with 50 mcg Matrix-M); 3) Group 3E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 100-mcg dose of mRNA-1273. Group 6E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 5x10^10 vp dose of Ad26.COV2.S, Group 9E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 30-mcg dose of BNT162b2, Group 11E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 100-mcg dose of mRNA-1273.211. Group 14E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 50-mcg dose of mRNA-1273, Group 17E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV2 rS vaccine with 50 mcg Matrix-M).
A telephone visit will occur one week after each primary EUA vaccination and one week after the booster dose. In person follow-up visits will occur on 14 days following completion of EUA vaccinations and on days 14, and 28 days after the booster dose, as well as 3, 6, and 12 months post the booster vaccination. Additional pools of subjects can be included if needed as additional COVID-19 vaccines are awarded EUA.
The primary objectives of this study are 1) to evaluate the safety and reactogenicity of delayed heterologous or homologous vaccine doses after EUA dosed vaccines, and 2) to evaluate the breadth of the humoral immune responses of heterologous and homologous delayed boost regimens following EUA dosing.
Detailed Description
A phase 1/2, open-label clinical trial in individuals, 18 years of age and older, who are in good health, have no known history of Coronavirus Disease 2019 (COVID-19) or Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, and meet all other eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of a delayed (>/=12 weeks) vaccine boost on a range of Emergency Use Authorization (EUA)-dosed COVID-19 vaccines (mRNA-1273, and mRNA-1273.211 manufactured by ModernaTX, Inc.; BNT162b2 manufactured by Pfizer/BioNTech; or Ad26.COV2.S manufactured by Janssen Pharmaceuticals/Johnson & Johnson). This is an adaptive design and may add arms (and increase sample size) as vaccines are awarded EUA and/or variant lineage spike vaccines are manufactured or become available. Enrollment will occur at up to twelve domestic clinical research sites.
This study includes two cohorts. Cohort 1 will include approximately 880 individuals (50 subjects/group; Groups 1E-14E, and 60 subjects/group; Groups 15E-17E) greater than 18 years of age and older, stratified into two age strata (18-55 years and >/=56 years) who previously received COVID-19 vaccine at Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100 mcg dose, two vaccinations of BNT162b2 at the 30 mcg dose, or one vaccination of Ad26.COV2.S at the 5x10^10 vp dose). Groups 15E-17E will enroll 60 subjects, split (approximately evenly) between age strata as able. Those subjects will be offered enrollment into this study >/=12 weeks after they received the last dose of their EUA vaccine. Subjects will receive a single open-label intramuscular (IM) injection of the designated delayed booster vaccine and will be followed through 12 months after vaccination: 1) Group 1E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp followed by a 100-mcg dose of mRNA-1273, Group 4E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp followed by a 5x10^10 vp dose of Ad26.COV2.S, Group 7E - previously EUA-dosed vaccination with Janssen - Ad26.COV.2.S 5x10^10 vp followed by a 30-mcg dose of BNT162b2, Group 10E - previously EUA-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp followed by a 100-mcg dose of mRNA-1273.211; Group 12E - previously EUA-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp followed by a 50-mcg dose of mRNA-1273; Group 15E - previously EUA-dosed vaccination with Janssen (two doses for Group 15E) - Ad26.COV2.S at 5x1010 vp followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV-2 rS vaccine with 50 mcg Matrix-M); 2) Group 2E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 100-mcg dose of mRNA-1273, Group 5E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 5x10^10 vp dose of Ad26.COV2.S, Group 8E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 30-mcg dose of BNT162b2, Group 13E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a 50-mcg dose of mRNA-1273; Group 16E - previously EUA-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV2 rS vaccine with 50 mcg Matrix-M); 3) Group 3E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 100-mcg dose of mRNA-1273. Group 6E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 5x10^10 vp dose of Ad26.COV2.S, Group 9E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 30-mcg dose of BNT162b2, Group 11E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 100-mcg dose of mRNA-1273.211. Group 14E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a 50-mcg dose of mRNA-1273, Group 17E - previously EUA-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses followed by a dose of NVX-CoV2373 (5 mcg Prototype SARS-CoV2 rS vaccine with 50 mcg Matrix-M).
A telephone visit will occur at Day 8 and in-person follow-up visits will occur on Days 15 and 29, as well as 3, 6, and 12 months after the vaccination. Cohort 2 will include approximately 250 participants per group aged >/=18 years of age who have not received a Coronavirus Disease 2019 (COVID-19) vaccine and have no known history of Coronavirus Disease 2019 (COVID-19) or SARS Coronavirus 2 (SARS-CoV-2) infection. They will be assigned to receive COVID-19 vaccine under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100mcg dose at a 28 days of interval). These pools of participants will be assigned 50 mcg mRNA-1273 at a minimum of 12 weeks following receipt of EUA dosing and followed through 12 months after the last vaccination. A telephone visit will occur one week after each primary EUA vaccination and one week after the booster dose. In person follow-up visits will occur on 14 days following completion of EUA vaccinations and on days 14, and 28 days after the booster dose, as well as 3, 6, and 12 months post the booster vaccination. Additional pools of subjects can be included if needed as additional COVID-19 vaccines are awarded EUA.
New groups may be added to Cohort 1 or 2 dependent upon manufacture of variant lineage spike protein-based vaccine constructs or vaccines newly awarded EUA. The primary objectives of this study are 1) to evaluate the safety and reactogenicity of delayed heterologous or homologous vaccine doses after EUA dosed vaccines, and 2) to evaluate the breadth of the humoral immune responses of heterologous and homologous delayed boost regimens following EUA dosing.
Conditions Module
Conditions
COVID-19
Keywords
Heterologous Nonvariant Boost
SARS-COV-2
SARS-COV-2 Vaccine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
867Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1 Group 10E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose). N = 50
Biological: mRNA-1273.211
Cohort 1 Group 11E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose). N = 50
Biological: mRNA-1273.211
Cohort 1 Group 12E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA- 1273 N = 50
Biological: mRNA-1273
Cohort 1 Group 13E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ad26.COV2.S
Biological
Formulated to contain 5x10^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-ß-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. Units are Electrochemiluminescence (ECL) Signal x 1/dilution (integrated).
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against B.1.351 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2
Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible to participate in this study:
Individuals >/= 18 years of age at the time of consent.
Received and completed primary mRNA COVID-19 vaccine under EUA dosing guidelines and one or two doses of Ad26.COV2.S at least 12 weeks prior to enrollment (Cohort 1 only).
Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures.
Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in good health.*
* Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
Female participants of childbearing potential may be enrolled in the study, if all of the following apply:
Practiced adequate contraception for 28 days prior to the first dose of vaccine (Day 1),
Has agreed to continue adequate contraception through 3 months following the booster dose,
Has a negative pregnancy test at screening and on the day of the first study vaccine dose (Day 1),
Is not currently breastfeeding.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded from the study:
Known history of SARS-CoV-2 infection. (for Cohort 1 and the primary series of Cohort 2).
Prior administration of an investigational coronavirus (SARS Coronavirus (SARS-CoV), Middle East Respiratory Syndrome (MERS-CoV)) vaccine or SARS Coronavirus 2 (SARS-CoV-2) monoclonal antibody in the preceding 90 days or current/planned simultaneous participation in another interventional study.
Receipt of SARS Coronavirus 2 (SARS-CoV-2) vaccine prior to study entry (Cohort 2 only).
A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine or nanolipid particles.
Receipt of any investigational study product within 28 days prior to enrollment.
Received or plans to receive a vaccine within 28 days prior to the first dose (Day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of study vaccine (with exception for seasonal influenza vaccine within 14 days of study vaccine).
Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular injections or blood draws, or previously experienced thrombosis with thrombocytopenia (TTS) or heparin-induced thrombocytopenia.
Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition.
Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids >/= 20 milligram per day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to Day 1.
Received immunoglobulin, blood-derived products, within 90 days prior to first study vaccination.
An immediate family member or household member of this study's personnel.
Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as >/= 38.0 degrees Celsius or 100.4 degrees Fahrenheit). Participants meeting this criterion may be rescheduled within the relevant window periods. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
99 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Kirsten E Lyke, M.D.
University of Maryland School of Medicine, Center for Vaccine Development and Global Health
Study Chair
Robert L Atmar, M.D.
Baylor College of Medicine
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The Hope Clinic of Emory University
Decatur
Georgia
30030-1705
United States
University of Maryland Baltimore - Institute of Human Virology
Atmar RL, Lyke KE, Posavad CM, Deming ME, Brady RC, Dobrzynski D, Edupuganti S, Mulligan MJ, Rupp RE, Rostad CA, Jackson LA, Martin JM, Shriver MC, Rajakumar K, Coler RN, El Sahly HM, Kottkamp AC, Branche AR, Frenck RW, Johnston C, Babu TM, Backer M, Archer JI, Crandon S, Nakamura A, Nayak SU, Szydlo D, Dominguez Islas CP, Brown ER, O'Connell SE, Montefiori DC, Eaton A, Neuzil KM, Stephens DS, Beigel JH, Pasetti M, Roberts PC. Mucosal and Systemic Antibody Responses After Boosting With a Bivalent Messenger RNA Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine. J Infect Dis. 2025 Oct 15;232(4):971-981. doi: 10.1093/infdis/jiaf176.
Cohort 1 provided rapid information about the safety, reactogenicity, and immunogenicity of delayed boost in a previously EUA-dosed group. Cohort 2 was an adaptive cohort that was vaccine-naïve that evaluated the safety, reactogenicity and immunogenicity of EUA-dosed vaccine followed by delayed boost.
Recruitment Details
Participants that enrolled in Cohort 1 Group 4E and then rolled over into Cohort 1 Group 15E signed separate informed consent documents prior to successful enrollment in each group. Cohort 1Group 15E referred to as Co 1 Gr 15E below.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose). N = 50
mRNA-1273: 0.5mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
Periods
Title
Milestones
Reasons Not Completed
All Cohorts Except 15E
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 6, 2023
Jun 10, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
study sites will administer product to which they have been assigned
Who Masked
Not provided
Biological: mRNA-1273
Cohort 1 Group 14E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
Biological: mRNA-1273
Cohort 1 Group 15E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10^10 vp for one or two doses stratified with two age ranges of 18-55 years (n= 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
Biological: SARS-CoV-2 rS/M1
Cohort 1 Group 16E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
Biological: SARS-CoV-2 rS/M1
Cohort 1 Group 17E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
Biological: SARS-CoV-2 rS/M1
Cohort 1 Group 1E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose). N = 50
Biological: mRNA-1273
Cohort 1 Group 2E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose). N = 50
Biological: mRNA-1273
Cohort 1 Group 3E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n ˜ 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose). N = 50
Biological: mRNA-1273
Cohort 1 Group 4E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose). N = 50
Biological: Ad26.COV2.S
Cohort 1 Group 5E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose). N = 50
Biological: Ad26.COV2.S
Cohort 1 Group 6E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose). N = 50
Biological: Ad26.COV2.S
Cohort 1 Group 7E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10^10 vp stratified with two age ranges of 18-55 years (n=˜ 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose). N = 50
Biological: BNT162b2
Cohort 1 Group 8E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose). N = 50
Biological: BNT162b2
Cohort 1 Group 9E
Experimental
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose). N = 50
Biological: BNT162b2
Cohort 2
Experimental
A prospective design cohort with naïve to COVID-19 vaccine and infection participants of > / = 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at the 100mcg dose at a 28 days of interval) followed by a delayed vaccination (50 mcg mRNA-1273) after a minimum of 12 weeks. A second booster (fourth dose) will be administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at a 4-12 month interval N=250
Biological: mRNA-1273
Biological: mRNA-1273.222
Cohort 1 Group 4E
Cohort 1 Group 5E
Cohort 1 Group 6E
BNT162b2
Biological
A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
Cohort 1 Group 7E
Cohort 1 Group 8E
Cohort 1 Group 9E
mRNA-1273
Biological
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV). Doses are either 0.25 mL or 0.5 mL.
Cohort 1 Group 12E
Cohort 1 Group 13E
Cohort 1 Group 14E
Cohort 1 Group 1E
Cohort 1 Group 2E
Cohort 1 Group 3E
Cohort 2
mRNA-1273.211
Biological
Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
Cohort 1 Group 10E
Cohort 1 Group 11E
mRNA-1273.222
Biological
Formulated in the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.
Cohort 2
SARS-CoV-2 rS/M1
Biological
SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume [w/v]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
Cohort 1 Group 15E
Cohort 1 Group 16E
Cohort 1 Group 17E
Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2
Geometric Mean AUC of Antibody Against BA.1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2
Geometric Mean AUC of Antibody Against BA.5 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1
Geometric Mean of Pseudovirus Neutralization against D614G
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.351
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.617.2
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.1.529
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Geometric Mean of Pseudovirus Neutralization against D614G
Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against BA.1
Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against BA.4/5
Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against XBB.1
Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Frequency of Any Unsolicited Adverse Events (AEs)
Number of participants who experienced any unsolicited AEs through 28 days post vaccination
Day 1 through Day 29 for Cohort 1, 28 days post any vaccination in Cohort 2
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)
Number of participants that experienced any AESIs during the course of the study. An adverse event of special interest (serious or nonserious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. AESIs include anosmia, ageusia, subacute thyroiditis, acute pancreatitis, appendicitis, rhabdomyolysis, acute respiratory distress syndrome, coagulation disorders, acute cardiovascular injury, acute kidney injury, acute liver injury, dermatologic findings, multisystem inflammatory disorders, thrombocytopenia, acute aseptic arthritis, new onset of or worsening of neurologic disease, anaphylaxis, and other syndromes.
For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Number of participants that experienced any NOCMCs during the course of the study
For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
Number of Participants With Any Medically-attended Adverse Events (MAAEs)
Number of participants that experienced MAAEs during the course of the study.
For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
Frequency of Any Serious Adverse Events (SAEs)
The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a lifethreatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)
Number of participants who experienced any systemic solicited AEs through 7 days post any vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever.
Day 1 through Day 8 for Cohort 1, and through 7 days post any vaccination for Cohort 2
Frequency of Local Solicited Reactogenicity Adverse Events (AEs)
Number of participants who experienced any local solicited AEs through 7 days post any vaccination. Local events include: pain at injection site, erythema, and induration.
Day 1 through Day 8 for Cohort 1, and through 7 days post any vaccination for Cohort 2
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.617.2 S2-P
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.1.529 S2-P
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against BA.1 S2-P
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against BA.5 S2-P
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Percent of Participants Who Seroconverted Against D614G for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.617.2
Day 15, Day 29
Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.1.529
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against D614G
Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against BA.1
Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against BA.4/5
Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against XBB.1
Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against D614G
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against BA.1
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against BA.4/5
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against XBB.1
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
Baltimore
Maryland
21201-1009
United States
NYU Langone Vaccine Center
New York
New York
10016
United States
University of Rochester Medical Center - Vaccine Research Unit
Rochester
New York
14642
United States
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati
Ohio
45206-1613
United States
University of Pittsburgh - Medicine - Infectious Diseases
Pittsburgh
Pennsylvania
15213-3205
United States
University of Texas Medical Branch
Galveston
Texas
77555-0435
United States
Baylor College of Medicine
Houston
Texas
77030-3411
United States
Kaiser Permanente Washington Health Research Institute
Seattle
Washington
98101-1466
United States
The University of Washington - Virology Research Clinic
Seattle
Washington
98104
United States
Derived
Marchese AM, Rousculp M, Macbeth J, Beyhaghi H, Seet BT, Toback S. The Novavax Heterologous Coronavirus Disease 2019 Booster Demonstrates Lower Reactogenicity Than Messenger RNA: A Targeted Review. J Infect Dis. 2024 Aug 16;230(2):e496-e502. doi: 10.1093/infdis/jiad519.
Atmar RL, Lyke KE, Deming ME, Jackson LA, Branche AR, El Sahly HM, Rostad CA, Martin JM, Johnston C, Rupp RE, Mulligan MJ, Brady RC, Frenck RW Jr, Backer M, Kottkamp AC, Babu TM, Rajakumar K, Edupuganti S, Dobrzynski D, Coler RN, Posavad CM, Archer JI, Crandon S, Nayak SU, Szydlo D, Zemanek JA, Dominguez Islas CP, Brown ER, Suthar MS, McElrath MJ, McDermott AB, O'Connell SE, Montefiori DC, Eaton A, Neuzil KM, Stephens DS, Roberts PC, Beigel JH; DMID 21-0012 Study Group. Homologous and Heterologous Covid-19 Booster Vaccinations. N Engl J Med. 2022 Mar 17;386(11):1046-1057. doi: 10.1056/NEJMoa2116414. Epub 2022 Jan 26.
FG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
FG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n ˜ 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
FG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
FG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
FG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
FG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10^10 vp stratified with two age ranges of 18-55 years (n=˜ 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
FG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
FG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
FG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
FG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
FG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA- 1273 N = 50
mRNA-1273: 0.25 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
FG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: 0.25 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
FG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: 0.25 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
FG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10^10 vp for one or two doses stratified with two age ranges of 18-55 years (n= 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume [w/v]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
FG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume [w/v]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
FG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume [w/v]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
FG017
Cohort 2
Prospective cohort with naïve to COVID-19 vaccine and infection participants >/= 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval N=250
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
mRNA-1273.222: Formulated the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.
FG00053 subjects
FG00151 subjects
FG00250 subjects
FG00350 subjects
FG00449 subjects
FG00551 subjects
FG00653 subjects
FG00751 subjects
FG00850 subjects
FG00943 subjects
FG01050 subjects
FG01147 subjects
FG01250 subjects
FG01346 subjects
FG0140 subjects
FG01516 subjects
FG01631 subjects
FG017106 subjects
COMPLETED
FG00050 subjects
FG00147 subjects
FG00247 subjects
FG00331 subjects
FG00441 subjects
FG00546 subjects
FG00648 subjects
FG00746 subjects
FG00845 subjects
FG00935 subjects
FG01044 subjects
FG01139 subjects
FG01243 subjects
FG01344 subjects
FG0140 subjects
FG01510 subjects
FG01622 subjects
FG01756 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0023 subjects
FG00319 subjects
FG0048 subjects
FG0055 subjects
FG0065 subjects
FG0075 subjects
FG0085 subjects
FG0098 subjects
FG0106 subjects
FG0118 subjects
FG0127 subjects
FG0132 subjects
FG0140 subjects
FG0156 subjects
FG0169 subjects
FG01750 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0035 subjects
FG004
Participant relocated, no follow-up planned
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Cohort 1 group 4E Participant rolled over into Cohort 1 group 15E
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00312 subjects
Participant unable to adhere to visit schedule
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Became ineligible after enrollment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Confirmed SARS CoV-2 infection
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Direct Enroll, Rollover to Co 1 Gr 15E
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG01420 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
BG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
BG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA) -dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n ˜ 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (delayed boost dose). N = 50
mRNA-1273: 0.5 mL Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
BG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (delayed boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
BG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (delayed boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
BG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (delayed boost dose). N = 50
Ad26.COV2.S: Formulated to contain 5x10^10 virus particles of the Ad26 vector encoding the S glycoprotein of SARS-CoV-2. Each dose of the Ad26.COV2.S vaccine also includes sodium chloride, citric acid monohydrate, trisodium citrate dihydrate, polysorbate-80, 2-hydroxypropyl-beta-cyclodextrin, and ethanol. Ad26.COV2.S will be used undiluted to obtain the specified vp content in 0.5 mL doses. Each dose is 0.5 mL.
BG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10^10 vp stratified with two age ranges of 18-55 years (n=˜ 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
BG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
BG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (delayed boost dose). N = 50
BNT162b2: A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. Each vial contains up to six doses. BNT162b2 (250 mcg/0.5 mL) will be administered in diluted 0.3 mL doses (30 mcg/0.3 mL).
BG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
BG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (delayed boost dose). N = 50
mRNA-1273.211: Lipid nanoparticle (LNP) dispersion containing 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the B.1.351 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273. mRNA-1273.211 (0.2 mg/mL) will be administered in 0.5 mL doses (100 mcg/0.5 mL).
BG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S at 5x10^10 vp stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA- 1273 N = 50
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
BG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
BG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30mcg for two doses stratified with two age ranges of 18-55 years (n = 25) and 56 or older (n = 25) randomized to receive a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273. N = 50
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
BG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV.2.S 5x10^10 vp for one or two doses stratified with two age ranges of 18-55 years (n= 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume [w/v]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
BG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna - mRNA-1273 at 100 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume [w/v]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
BG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Adaptive design cohort with participants that previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses stratified with two age ranges of 18-55 years (n = 30) and 56 or older (n = 30) randomized to receive a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2). N =60
SARS-CoV-2 rS/M1: SARS-CoV-2 rS Drug Substance containing the prototype Wuhan is formulated with saponin-based Matrix-M adjuvant in a buffer of 25 mM sodium phosphate (pH 7.2), 300 mM sodium chloride, and 0.01% (weight per volume [w/v]) polysorbate 80. NVX-Co-V2373 will be administered in 0.5 mL dose (5 mcg Prototype SARS-CoV-2 rS with 50 mcg Matrix-M adjuvant)
BG017
Cohort 2
Prospective cohort with naïve to COVID-19 vaccine and infection participants >/= 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval N=250
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
mRNA-1273.222: Formulated the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00053
BG00151
BG00250
BG00350
BG00449
BG00551
BG00653
BG00751
BG00850
BG00943
BG01050
BG01147
BG01250
BG01346
BG01420
BG01516
BG01631
BG017106
BG018867
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
Mean
Standard Deviation
years
Title
Denominators
Categories
All Cohorts except 15E
ParticipantsBG00053
ParticipantsBG00151
ParticipantsBG00250
ParticipantsBG003
Sex: Female, Male
All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
Count of Participants
Participants
Title
Denominators
Categories
All Cohorts Except 15E
ParticipantsBG00053
ParticipantsBG00151
ParticipantsBG002
Ethnicity (NIH/OMB)
All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
Count of Participants
Participants
Title
Denominators
Categories
All Cohorts Except 15E
ParticipantsBG00053
ParticipantsBG00151
ParticipantsBG002
Race/Ethnicity, Customized
All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
Count of Participants
Participants
Title
Denominators
Categories
All Cohorts Except 15E
ParticipantsBG00053
ParticipantsBG00151
ParticipantsBG002
Height
All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
Mean
Standard Deviation
cm
Title
Denominators
Categories
All Cohorts except 15E
ParticipantsBG00053
ParticipantsBG00151
ParticipantsBG002
Weight
All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
Mean
Standard Deviation
kg
Title
Denominators
Categories
All Groups Except 15E
ParticipantsBG00053
ParticipantsBG00151
ParticipantsBG002
BMI
All Cohorts except 15E reported on Row 1, and Cohort 1 Group 15E is reported on Row 2. This is to prevent counting the participants who rolled over into Cohort 1 Group 15E (from Cohort 1 Group 4E) on the same row.
Mean
Standard Deviation
kg/m2
Title
Denominators
Categories
All Cohorts except 15E
ParticipantsBG00053
ParticipantsBG00151
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Geometric Mean of Area Under the Curve (AUC) of Antibody Against WA-1 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method. Units are Electrochemiluminescence (ECL) Signal x 1/dilution (integrated).
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Geometric Mean
95% Confidence Interval
Arbitrary Unit*1/dilution
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00053
OG00151
OG00250
OG003
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG003
Primary
Geometric Mean of AUC of Antibody Against B.1.351 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against B.1.351 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Geometric Mean
95% Confidence Interval
Arbitrary Unit*1/dilution
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against B.1.617.2 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Geometric Mean
95% Confidence Interval
Arbitrary Unit*1/dilution
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P for Cohort 1
Geometric Mean AUC of Antibody Against B.1.1.529 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Geometric Mean
95% Confidence Interval
Arbitrary Unit*1/dilution
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Geometric Mean AUC of Antibody of Antibody Against WA-1 S2-P for Cohort 2
Geometric Mean AUC of Antibody Against WA-1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Arbitrary Unit*1/dilution
Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Geometric Mean AUC of Antibody Against BA.1 S2-P for Cohort 2
Geometric Mean AUC of Antibody Against BA.1 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Arbitrary Unit*1/dilution
Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Geometric Mean AUC of Antibody Against BA.5 S2-P for Cohort 2
Geometric Mean AUC of Antibody Against BA.5 S2-P using 10-plex ECLIA Assay. Area was computed for electrochemiluminescence signal across sample dilutions using a trapezoidal method.
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
Arbitrary Unit*1/dilution
Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 1
Geometric Mean of Pseudovirus Neutralization against D614G
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Primary
Geometric Mean of Pseudovirus Neutralization Against B.1.351 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.351
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. A subset of participants was analyzed for Group 1E-9E and 12E-14E.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Primary
Geometric Mean of Pseudovirus Neutralization Against B.1.617.2 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.617.2
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. A subset of participants was analyzed for Groups 1E-3E and 10E-11E at Day 29.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Geometric Mean of Pseudovirus Neutralization Against B.1.1.529 for Cohort 1
Geometric Mean of Pseudovirus Neutralization against B.1.1.529
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 Pre-Booster Dose, Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Primary
Geometric Mean of Pseudovirus Neutralization Against D614G for Cohort 2
Geometric Mean of Pseudovirus Neutralization against D614G
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Geometric Mean of Pseudovirus Neutralization Against BA.1 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against BA.1
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Geometric Mean of Pseudovirus Neutralization Against BA.4/5 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against BA.4/5
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Geometric Mean of Pseudovirus Neutralization Against XBB.1 for Cohort 2
Geometric Mean of Pseudovirus Neutralization against XBB.1
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 Pre-Vaccination 1, Day 43 Post-Vaccination 1, Day 15 Post-Booster Dose 1, Day 1 Pre-Booster Dose 2, Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Frequency of Any Unsolicited Adverse Events (AEs)
Number of participants who experienced any unsolicited AEs through 28 days post vaccination
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
Day 1 through Day 29 for Cohort 1, 28 days post any vaccination in Cohort 2
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Frequency of Any Protocol Specified Adverse Events of Special Interest (AESIs)
Number of participants that experienced any AESIs during the course of the study. An adverse event of special interest (serious or nonserious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor is required. AESIs include anosmia, ageusia, subacute thyroiditis, acute pancreatitis, appendicitis, rhabdomyolysis, acute respiratory distress syndrome, coagulation disorders, acute cardiovascular injury, acute kidney injury, acute liver injury, dermatologic findings, multisystem inflammatory disorders, thrombocytopenia, acute aseptic arthritis, new onset of or worsening of neurologic disease, anaphylaxis, and other syndromes.
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Frequency of Any New-onset Chronic Medical Conditions (NOCMCs)
Number of participants that experienced any NOCMCs during the course of the study
Posted
Count of Participants
Participants
For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Number of Participants With Any Medically-attended Adverse Events (MAAEs)
Number of participants that experienced MAAEs during the course of the study.
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Frequency of Any Serious Adverse Events (SAEs)
The number of participants that experience any SAEs from Day 1 to study completion. An AE or suspected adverse reaction is considered serious if, in the view of either the participating site PI or appropriate sub-investigator or the sponsor, it results in: death, a lifethreatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
For Cohort 1, Day 1 through Day 366; for Cohort 2, Day 1 through Day 590
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Frequency of Systemic Solicited Reactogenicity Adverse Events (AEs)
Number of participants who experienced any systemic solicited AEs through 7 days post any vaccination. Systemic events include: fatigue, headache, myalgia, arthralgia, nausea, chills and fever.
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
Day 1 through Day 8 for Cohort 1, and through 7 days post any vaccination for Cohort 2
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Frequency of Local Solicited Reactogenicity Adverse Events (AEs)
Number of participants who experienced any local solicited AEs through 7 days post any vaccination. Local events include: pain at injection site, erythema, and induration.
The Safety Analysis population for the main study includes all participants who received one dose of vaccine.
Posted
Count of Participants
Participants
Day 1 through Day 8 for Cohort 1, and through 7 days post any vaccination for Cohort 2
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Primary
Percent of Participants Who Seroconverted Against B.1.351 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.351 S2-P
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Primary
Percent of Participants Who Seroconverted Against B.1.617.2 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.617.2 S2-P
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Primary
Percent of Participants Who Seroconverted Against B.1.1.529 S2-P for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against B.1.1.529 S2-P
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Primary
Percent of Participants Who Seroconverted Against WA-1 S2-P for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against WA-1 S2-P
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Percent of Participants Who Seroconverted Against BA.1 S2-P for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against BA.1 S2-P
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Percent of Participants Who Seroconverted Against BA.5 S2-P for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in antibody titer from baseline against BA.5 S2-P
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Percent of Participants Who Seroconverted Against D614G for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against D614G
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Primary
Percent of Participants Who Seroconverted Against B.1.351 for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.351
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. A subset of participants was analyzed for Group 1E-9E and 12E-14E.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Percent of Participants Who Seroconverted Against B.1.617.2 for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.617.2
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified. This assay was not completed for Group 15E, 16E, and 17E.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15, Day 29
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
Primary
Percent of Participants Who Seroconverted Against B.1.1.529 for Cohort 1
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from baseline against B.1.1.529
The mITT population for the population includes all enrolled participants who received the booster vaccine and contributed both pre- and at least one post-vaccination boost venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported. When 0 participants are indicated, the assay was not performed for the applicable arm at the time point specified.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15, Day 29, Day 91, Day 181, Day 273, Day 366
ID
Title
Description
OG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
OG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG002
Primary
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against D614G
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG000
Primary
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against BA.1
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG000
Primary
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against BA.4/5
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG000
Primary
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against XBB.1
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 43 Post-Dose 1, Day 15 Post Booster Dose 1
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG000
Primary
Percent of Participants Who Seroconverted Against D614G for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Dose 1 against D614G
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Percent of Participants Who Seroconverted Against BA.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against BA.1
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Percent of Participants Who Seroconverted Against BA.4/5 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against BA.4/5
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Primary
Percent of Participants Who Seroconverted Against XBB.1 for Cohort 2
Percent of participants who seroconverted defined as a 4-fold change in pseudovirus neutralization from Pre-Booster Dose 2 against XBB.1
The primary immunogenicity population includes enrolled participants who received all the study vaccines, including the second booster vaccination (Moderna mRNA-1273.222) and who contributed both pre- and at least one post-second booster vaccination venous blood sample for the corresponding immunogenicity endpoint testing and for which valid results were reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 15 Post-Booster Dose 2, Day 29 Post-Booster Dose 2, Day 91 Post-Booster Dose 2, Day 181 Post-Booster Dose 2
ID
Title
Description
OG000
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
Time Frame
Solicited AEs were collected from the time of each vaccination through 7 days post each vaccination. Participants were also assessed for delayed onset local reactions through 14 days post each vaccination. Unsolicited AEs of all severities were reported from the time of study product administration through 28 days post each vaccination. SAEs, AESIs, MAAEs and NOCMCs were reported from the time of study product administration through end of study (Day 366 for Cohort 1 and Day 590 for Cohort 2).
Description
After 28 days post last vaccination through the end of planned study participation, only SAEs, AESIs, MAAEs, and NOCMCs will be reported as AEs; end of planned study participation for Cohort 1 is Day 366 and for Cohort 2 is Day 590. For the 12 participants that rolled over from Cohort 1 Group 4E into Cohort 1 Group 15E, any adverse events that were reported are counted based on the group that they were enrolled in at the time of the event.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1 Group 1E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of 100-mcg dose of mRNA-1273 (boost dose).
0
53
2
53
49
53
EG001
Cohort 1 Group 2E (Prime mRNA-1273, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
1
51
4
51
49
51
EG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
0
50
0
50
50
50
EG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
0
50
1
50
46
50
EG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
0
49
1
49
46
49
EG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
0
51
2
51
47
51
EG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
0
52
1
52
52
52
EG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
0
51
1
51
50
51
EG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
0
50
0
50
50
50
EG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
0
43
0
43
43
43
EG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
0
50
2
50
48
50
EG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
0
47
1
47
46
47
EG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
0
50
1
50
49
50
EG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
0
46
1
56
46
46
EG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
0
20
0
20
18
20
EG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
0
16
0
16
12
16
EG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
0
31
1
31
27
31
EG017
Cohort 2
Prospective cohort with naïve to COVID-19 vaccine and infection participants >/= 18 years of age to receive COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval N=250
mRNA-1273: Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
mRNA-1273.222: Formulated the same way as the mRNA-1273 vaccine but contains 1:1 mix of mRNAs that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the prefusion stabilized S protein of the Wuhan-Hu-1 strain used in mRNA-1273.
0
106
5
106
100
106
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Head injury
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG0030 events0 affected50 at risk
EG004
Endometrial thickening
Reproductive system and breast disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Heat stroke
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Seizure
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Idiopathic pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Intracranial mass
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Myasthenia gravis
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected50 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00942
OG01050
OG01146
OG01250
OG01346
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00550
ParticipantsOG00652
ParticipantsOG00751
ParticipantsOG00850
ParticipantsOG00942
ParticipantsOG01050
ParticipantsOG01146
ParticipantsOG01250
ParticipantsOG01346
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG000942.30(744.40 to 1192.81)
OG00111013.62(9254.21 to 13107.54)
OG0026047.85(4839.00 to 7558.69)
OG003
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 29
ParticipantsOG00052
ParticipantsOG00151
ParticipantsOG00249
ParticipantsOG00348
Day 91
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Day 181
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
Day 366
ParticipantsOG00050
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00330
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00942
OG01050
OG01146
OG01250
OG01346
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00551
ParticipantsOG00652
ParticipantsOG00751
ParticipantsOG00850
ParticipantsOG00942
ParticipantsOG01050
ParticipantsOG01146
ParticipantsOG01250
ParticipantsOG01346
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG0001396.82(1093.87 to 1783.67)
OG00114461.60(12217.34 to 17118.11)
OG0027615.66(6046.08 to 9592.70)
OG003
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 29
ParticipantsOG00052
ParticipantsOG00151
ParticipantsOG00249
ParticipantsOG00348
Day 91
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Day 181
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
Day 366
ParticipantsOG00050
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00330
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00942
OG01050
OG01146
OG01250
OG01346
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00550
ParticipantsOG00652
ParticipantsOG00751
ParticipantsOG00850
ParticipantsOG00942
ParticipantsOG01050
ParticipantsOG01146
ParticipantsOG01250
ParticipantsOG01346
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG000355.20(274.70 to 459.29)
OG0016123.52(4971.22 to 7542.92)
OG0022749.80(2052.91 to 3683.26)
OG003
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 29
ParticipantsOG00052
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00348
Day 91
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Day 181
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
Day 366
ParticipantsOG00050
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00330
OG00030
Title
Denominators
Categories
Day 1, Pre-Booster Vaccination 2
ParticipantsOG00030
Title
Measurements
OG000193349.76(136074.53 to 274732.75)
Day 15
ParticipantsOG00028
Title
Measurements
OG0001201152.28(899527.72 to 1603915.89)
Day 29
ParticipantsOG00027
Title
Measurements
OG000921655.60(684452.31 to 1241063.88)
Day 91
ParticipantsOG00029
Title
Measurements
OG000688925.53(520392.79 to 912038.74)
Day 181
ParticipantsOG00027
Title
Measurements
OG000445271.64(344427.79 to 575641.23)
OG00030
Title
Denominators
Categories
Day 1, Pre-Booster Vaccination 2
ParticipantsOG00030
Title
Measurements
OG00044367.39(30868.36 to 63769.67)
Day 15
ParticipantsOG00028
Title
Measurements
OG000365421.15(265045.53 to 503810.10)
Day 29
ParticipantsOG00027
Title
Measurements
OG000260668.10(185214.52 to 366860.32)
Day 91
ParticipantsOG00029
Title
Measurements
OG000178509.53(129548.91 to 245973.92)
Day 181
ParticipantsOG00027
Title
Measurements
OG00092349.30(69580.26 to 122569.16)
OG00030
Title
Denominators
Categories
Day 1, Pre-Booster Vaccination 2
ParticipantsOG00030
Title
Measurements
OG00048314.42(33707.06 to 69252.05)
Day 15
ParticipantsOG00028
Title
Measurements
OG000409932.34(305116.01 to 550756.16)
Day 29
ParticipantsOG00027
Title
Measurements
OG000297241.68(219857.75 to 401862.64)
4Day 91
ParticipantsOG00029
Title
Measurements
OG000215637.56(159513.03 to 291509.47)
Day 181
ParticipantsOG00027
Title
Measurements
OG000128920.81(98994.66 to 167893.67)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00942
OG01050
OG01146
OG01250
OG01346
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00551
ParticipantsOG00652
ParticipantsOG00751
ParticipantsOG00850
ParticipantsOG00942
ParticipantsOG01050
ParticipantsOG01146
ParticipantsOG01250
ParticipantsOG01346
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG00038.68(26.71 to 56.03)
OG001378.03(288.46 to 495.41)
OG002102.44(74.23 to 141.38)
OG003
Day 15
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00350
Day 29
ParticipantsOG00052
ParticipantsOG00151
ParticipantsOG00249
ParticipantsOG00348
Day 91
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Day 181
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
Day 366
ParticipantsOG00049
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00330
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00020
OG00120
OG00220
OG00320
OG00420
OG00520
OG00620
OG00720
OG00820
OG00942
OG01050
OG01120
OG01226
OG01320
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00320
ParticipantsOG00420
ParticipantsOG00520
ParticipantsOG00620
ParticipantsOG00720
ParticipantsOG00820
ParticipantsOG00942
ParticipantsOG01050
ParticipantsOG01120
ParticipantsOG01220
ParticipantsOG01320
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG0008.66(5.50 to 13.63)
OG00129.74(17.80 to 49.69)
OG00217.81(13.14 to 24.15)
OG003
Day 15
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00320
Day 29
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00219
ParticipantsOG00320
Day 91
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00320
Day 181
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00219
ParticipantsOG00318
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 366
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00920
OG01020
OG01146
OG01250
OG01346
OG0140
OG0150
OG0160
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00551
ParticipantsOG00652
ParticipantsOG00751
ParticipantsOG00850
ParticipantsOG00920
ParticipantsOG01020
ParticipantsOG01146
ParticipantsOG01250
ParticipantsOG01346
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
Title
Measurements
OG00012.02(8.07 to 17.92)
OG001101.40(75.48 to 136.24)
OG00229.57(21.58 to 40.50)
OG003
Day 15
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00350
Day 29
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG0030
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00942
OG01050
OG01146
OG01250
OG01346
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 1, Pre-Dose
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00551
ParticipantsOG00652
ParticipantsOG00751
ParticipantsOG00850
ParticipantsOG00942
ParticipantsOG01050
ParticipantsOG01146
ParticipantsOG01250
ParticipantsOG01346
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG0006.04(5.34 to 6.82)
OG00128.96(22.26 to 37.67)
OG00214.06(10.50 to 18.82)
OG003
Day 15
ParticipantsOG0000
ParticipantsOG00110
ParticipantsOG0020
ParticipantsOG00310
Day 29
ParticipantsOG00052
ParticipantsOG00151
ParticipantsOG00249
ParticipantsOG00348
Day 91
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Day 181
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
Day 366
ParticipantsOG00049
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00330
OG00030
Title
Denominators
Categories
Day 1, Pre-Vaccination 1
ParticipantsOG00030
Title
Measurements
OG00013.23(6.82 to 25.67)
Day 43, Post Vaccination 1
ParticipantsOG00030
Title
Measurements
OG0004010.57(2785.54 to 5774.35)
Day 15, Post Booster Vaccination 1
ParticipantsOG00030
Title
Measurements
OG0007456.62(4647.00 to 11964.94)
Day 1, Pre-Booster Vaccination 2
ParticipantsOG00030
Title
Measurements
OG0002225.56(1468.38 to 3373.20)
Day 15, Post-Booster Vaccination 2
ParticipantsOG00028
Title
Measurements
OG00018927.45(13150.29 to 27242.60)
Day 29, Post-Booster Vaccination 2
ParticipantsOG00027
Title
Measurements
OG00017481.83(11657.50 to 26216.11)
Day 91, Post-Booster Vaccination 2
ParticipantsOG00029
Title
Measurements
OG0009244.35(6596.46 to 12955.15)
Day 181, Post-Booster Vaccination 2
ParticipantsOG00027
Title
Measurements
OG0003932.11(2993.93 to 5164.27)
OG00030
Title
Denominators
Categories
Day 1, Pre-Vaccination 1
ParticipantsOG00030
Title
Measurements
OG0006.36(4.51 to 8.96)
Day 43, Post Vaccination 1
ParticipantsOG00030
Title
Measurements
OG000189.09(100.15 to 357.04)
Day 15, Post Booster Vaccination 1
ParticipantsOG00030
Title
Measurements
OG0002680.27(1368.13 to 5250.85)
Day 1, Pre-Booster Vaccination 2
ParticipantsOG00030
Title
Measurements
OG000679.09(376.79 to 1223.91)
Day 15, Post-Booster Vaccination 2
ParticipantsOG00028
Title
Measurements
OG00012381.92(7615.21 to 20132.34)
Day 29, Post-Booster Vaccination 2
ParticipantsOG00027
Title
Measurements
OG0009496.08(5113.33 to 17635.40)
Day 91, Post-Booster Vaccination 2
ParticipantsOG00029
Title
Measurements
OG0003272.98(2290.23 to 4677.44)
Day 181, Post-Booster Vaccination 2
ParticipantsOG00027
Title
Measurements
OG0004076.50(2337.99 to 7107.76)
OG00030
Title
Denominators
Categories
Day 1, Pre-Vaccination 1
ParticipantsOG00030
Title
Measurements
OG0007.59(4.83 to 11.93)
Day 43, Post Vaccination 1
ParticipantsOG00030
Title
Measurements
OG000260.47(141.07 to 480.92)
Day 15, Post Booster Vaccination 1
ParticipantsOG00030
Title
Measurements
OG0001377.38(854.38 to 2220.54)
Day 1, Pre-Booster Vaccination 2
ParticipantsOG00030
Title
Measurements
OG000464.55(253.81 to 850.28)
Day 15, Post-Booster Vaccination 2
ParticipantsOG00028
Title
Measurements
OG00010328.08(6854.83 to 15561.19)
Day 29, Post-Booster Vaccination 2
ParticipantsOG00027
Title
Measurements
OG0007558.08(4947.10 to 11547.08)
Day 91, Post-Booster Vaccination 2
ParticipantsOG00029
Title
Measurements
OG0006848.36(4320.84 to 10854.38)
Day 181, Post-Booster Vaccination 2
ParticipantsOG00027
Title
Measurements
OG0002540.36(1707.64 to 3779.15)
OG00030
Title
Denominators
Categories
Day 1, Pre-Vaccination 1
ParticipantsOG00030
Title
Measurements
OG0005.28(4.72 to 5.91)
Day 43, Post Vaccination 1
ParticipantsOG00030
Title
Measurements
OG00024.37(14.01 to 42.37)
Day 15, Post Booster Vaccination 1
ParticipantsOG00030
Title
Measurements
OG000132.74(75.92 to 232.10)
Day 1, Pre-Booster Vaccination 2
ParticipantsOG00030
Title
Measurements
OG00039.52(24.28 to 64.33)
Day 15, Post-Booster Vaccination 2
ParticipantsOG00028
Title
Measurements
OG000969.29(576.68 to 1629.20)
Day 29, Post-Booster Vaccination 2
ParticipantsOG00027
Title
Measurements
OG000648.84(389.17 to 1081.76)
Day 91, Post-Booster Vaccination 2
ParticipantsOG00029
Title
Measurements
OG000462.50(288.10 to 742.47)
Day 181, Post-Booster Vaccination 2
ParticipantsOG00027
Title
Measurements
OG000211.99(135.32 to 332.10)
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG017
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00943
OG01050
OG01147
OG01250
OG01346
OG01420
OG01516
OG01631
OG017106
Title
Denominators
Categories
Title
Measurements
OG00028
OG00129
OG00231
OG00331
OG00428
OG00528
OG00628
OG00729
OG00824
OG00922
OG01024
OG01120
OG01230
OG01325
OG0148
OG0156
OG01614
OG01760
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG017
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00943
OG01050
OG01147
OG01250
OG01346
OG01420
OG01516
OG01631
OG017106
Title
Denominators
Categories
Title
Measurements
OG0000
OG0012
OG0020
OG0031
OG0041
OG0050
OG0061
OG0071
OG0080
OG0090
OG0100
OG0110
OG0122
OG0132
OG0140
OG0150
OG0161
OG0175
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG017
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00943
OG01050
OG01147
OG01250
OG01346
OG01420
OG01516
OG01631
OG017106
Title
Denominators
Categories
Title
Measurements
OG0000
OG0016
OG0022
OG0033
OG0043
OG0051
OG0061
OG0074
OG0082
OG0092
OG0100
OG0112
OG0123
OG0131
OG0140
OG0150
OG0162
OG0172
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG017
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00943
OG01050
OG01147
OG01250
OG01346
OG01420
OG01516
OG01631
OG017106
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0091
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0171
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG017
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00943
OG01050
OG01147
OG01250
OG01346
OG01420
OG01516
OG01631
OG017106
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG0020
OG0031
OG0041
OG0052
OG0061
OG0071
OG0080
OG0090
OG0102
OG0111
OG0121
OG0131
OG0140
OG0150
OG0161
OG0175
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG017
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00943
OG01050
OG01147
OG01250
OG01346
OG01420
OG01516
OG01631
OG017106
Title
Denominators
Categories
Title
Measurements
OG00038
OG00147
OG00245
OG00339
OG00442
OG00542
OG00639
OG00738
OG00846
OG00937
OG01038
OG01141
OG01242
OG01340
OG01417
OG01510
OG01623
OG01793
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Boost mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG017
Cohort 2 (Vaccine naïve, Received Moderna mRNA-1273.222)
Naïve to COVID-19 vaccine and infection, received COVID-19 vaccine intramuscularly under Emergency Use Authorization dosing (EUA) (two vaccinations of mRNA-1273 at 100mcg dose at 28 day interval) followed by delayed booster vaccination (50 mcg mRNA-1273) after minimum 12 weeks. Second booster administered intramuscular using Moderna mRNA-1273.222 at 50 mcg at 4-12 month interval
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00943
OG01050
OG01147
OG01250
OG01346
OG01420
OG01516
OG01631
OG017106
Title
Denominators
Categories
Title
Measurements
OG00041
OG00144
OG00241
OG00338
OG00435
OG00535
OG00648
OG00739
OG00845
OG00939
OG01045
OG01142
OG01241
OG01340
OG01411
OG0155
OG01616
OG01794
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00052
OG00151
OG00250
OG00348
OG00448
OG00550
OG00652
OG00751
OG00850
OG00941
OG01050
OG01146
OG01249
OG01346
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG01458(33 to 80)
OG01547(21 to 73)
OG01645(26 to 64)
Day 29
ParticipantsOG00052
ParticipantsOG00151
ParticipantsOG00249
ParticipantsOG00348
Day 91
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Day 181
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
Day 366
ParticipantsOG00050
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00330
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00052
OG00151
OG00250
OG00348
OG00448
OG00550
OG00652
OG00751
OG00850
OG00941
OG01050
OG01146
OG01250
OG01346
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG01484(60 to 97)
OG01553(27 to 79)
OG01655(36 to 74)
Day 29
ParticipantsOG00052
ParticipantsOG00151
ParticipantsOG00249
ParticipantsOG00348
Day 91
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Day 181
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
Day 366
ParticipantsOG00050
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00330
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00052
OG00151
OG00250
OG00348
OG00448
OG00550
OG00652
OG00751
OG00850
OG00941
OG01050
OG01146
OG01250
OG01346
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG01468(43 to 87)
OG01553(27 to 79)
OG01652(33 to 71)
Day 29
ParticipantsOG00052
ParticipantsOG00151
ParticipantsOG00249
ParticipantsOG00348
Day 91
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Day 181
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
Day 366
ParticipantsOG00050
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00330
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00052
OG00151
OG00250
OG00348
OG00448
OG00550
OG00652
OG00751
OG00850
OG00941
OG01050
OG01146
OG01250
OG01346
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG01484(60 to 97)
OG01560(32 to 84)
OG01659(39 to 76)
Day 29
ParticipantsOG00052
ParticipantsOG00151
ParticipantsOG00249
ParticipantsOG00348
Day 91
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Day 181
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
Day 366
ParticipantsOG00050
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00330
OG00029
Title
Denominators
Categories
Day 15
ParticipantsOG00028
Title
Measurements
OG00061(41 to 78)
Day 29
ParticipantsOG00027
Title
Measurements
OG00056(35 to 75)
Day 91
ParticipantsOG00029
Title
Measurements
OG00041(24 to 61)
Day 181
ParticipantsOG00027
Title
Measurements
OG00026(11 to 46)
OG00029
Title
Denominators
Categories
Day 15
ParticipantsOG00028
Title
Measurements
OG00079(59 to 92)
Day 29
ParticipantsOG00027
Title
Measurements
OG00070(50 to 86)
Day 91
ParticipantsOG00029
Title
Measurements
OG00038(21 to 58)
Day 181
ParticipantsOG00027
Title
Measurements
OG00019(6 to 38)
OG00029
Title
Denominators
Categories
Day 15
ParticipantsOG00028
Title
Measurements
OG00079(59 to 92)
Day 29
ParticipantsOG00027
Title
Measurements
OG00070(50 to 86)
Day 91
ParticipantsOG00029
Title
Measurements
OG00045(26 to 64)
Day 181
ParticipantsOG00027
Title
Measurements
OG00037(19 to 58)
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00551
OG00652
OG00751
OG00850
OG00941
OG01050
OG01146
OG01250
OG01346
OG01419
OG01515
OG01629
Title
Denominators
Categories
Day 15
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00550
ParticipantsOG00652
ParticipantsOG00751
ParticipantsOG00849
ParticipantsOG00941
ParticipantsOG01050
ParticipantsOG01143
ParticipantsOG01249
ParticipantsOG01345
ParticipantsOG01419
ParticipantsOG01515
ParticipantsOG01629
Title
Measurements
OG000100(93 to 100)
OG00184(71 to 93)
OG002100(93 to 100)
OG003
Day 29
ParticipantsOG00052
ParticipantsOG00151
ParticipantsOG00249
ParticipantsOG00348
Day 91
ParticipantsOG00051
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Day 181
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00325
Day 366
ParticipantsOG00049
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00330
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
Units
Counts
Participants
OG00020
OG00120
OG00220
OG00320
OG00420
OG00520
OG00620
OG00720
OG00820
OG00941
OG01050
OG01120
OG01220
OG01320
OG01419
OG01514
OG01629
Title
Denominators
Categories
Day 15
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00320
ParticipantsOG00420
ParticipantsOG00520
ParticipantsOG00620
ParticipantsOG00720
ParticipantsOG00820
ParticipantsOG00941
ParticipantsOG01050
ParticipantsOG01120
ParticipantsOG01220
ParticipantsOG01320
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
Title
Measurements
OG00095(75 to 99)
OG00195(75 to 99)
OG002100(83 to 100)
OG003
Day 29
ParticipantsOG00018
ParticipantsOG00120
ParticipantsOG00219
ParticipantsOG00320
Day 91
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00320
Day 181
ParticipantsOG00020
ParticipantsOG00119
ParticipantsOG00219
ParticipantsOG00318
Day 273
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 366
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
Units
Counts
Participants
OG00053
OG00151
OG00250
OG00350
OG00449
OG00550
OG00652
OG00751
OG00849
OG00920
OG01020
OG01145
OG01248
OG01344
Title
Denominators
Categories
Day 15
ParticipantsOG00053
ParticipantsOG00151
ParticipantsOG00250
ParticipantsOG00350
ParticipantsOG00449
ParticipantsOG00550
ParticipantsOG00652
ParticipantsOG00751
ParticipantsOG00849
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG01142
ParticipantsOG01248
ParticipantsOG01344
Title
Measurements
OG00094(84 to 99)
OG00186(74 to 94)
OG002100(93 to 100)
OG003
Day 29
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG0030
Cohort 1 Group 3E (Prime BNT162b2, Boost 100 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273 (boost dose).
OG003
Cohort 1 Group 4E (Prime Ad26.COV2.S, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG004
Cohort 1 Group 5E (Prime mRNA-1273, Boost Ad26.COV2.S)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG005
Cohort 1 Group 6E (Prime BNT162b2, Boost Ad26.COV2.S)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of Ad26.COV2.S 5x10^10 vp (boost dose).
OG006
Cohort 1 Group 7E (Prime Ad26.COV2.S, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG007
Cohort 1 Group 8E (Prime mRNA-1273, Boost BNT162b2)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG008
Cohort 1 Group 9E (Prime BNT162b2, Boost BNT162b2)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 30-mcg dose of BNT162b2 (boost dose).
OG009
Cohort 1 Group 10E (Prime Ad26.COV2.S, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG010
Cohort 1 Group 11E (Prime BNT162b2, Boost 100 mcg mRNA-1273.211)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 100-mcg dose of mRNA-1273.211 (boost dose).
OG011
Cohort 1 Group 12E (Prime Ad26.COV2.S, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG012
Cohort 1 Group 13E (Prime mRNA-1273, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG013
Cohort 1 Group 14E (Prime BNT162b2, Boost 50 mcg mRNA-1273)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 50-mcg dose of mRNA-1273.
OG014
Cohort 1 Group 15E (Prime Ad26.COV2.S, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Janssen - Ad26.COV2-S 5x10^10 vp, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG015
Cohort 1 Group 16E (Prime mRNA-1273, Boost NVX-CoV2373)
Previously (>/=12 weeks) received Emergency Use Authorization (EUA)-dosed vaccination with Moderna-mRNA-1273 at 100mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).
OG016
Cohort 1 Group 17E (Prime BNT162b2, Boost NVX-CoV2373)
Previously (>/=12 weeks) dosed with Emergency Use Authorization (EUA)-dosed vaccination with Pfizer/BioNTech - BNT162b2 at 30 mcg for two doses, received a single intramuscular (IM) injection of a 5-mcg dose of NVX-CoV2373 (SARS-COV-2).