Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines | NCT04529538 | Trialant
NCT04529538
Sponsor
PATH
Status
Completed
Last Update Posted
Nov 20, 2024Actual
Enrollment
226Actual
Phase
Phase 1
Conditions
Poliomyelitis
Interventions
Novel Oral Polio Vaccine Type 1 (nOPV1)
Novel Oral Polio Vaccine Type 3 (nOPV3)
Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)
Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04529538
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CVIA 076
Secondary IDs
Not provided
Brief Title
Study of Novel Types 1 and 3 Oral Poliomyelitis Vaccines
Official Title
A First-in-human, Phase 1, Randomized, Observer-blind, Controlled Study to Assess the Safety and Immunogenicity of Novel Live Attenuated Type 1 and Type 3 Oral Poliomyelitis Vaccines in Healthy Adults
Acronym
Not provided
Organization
PATHOTHER
Status Module
Record Verification Date
Oct 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
Mar 26, 2021Actual
Primary Completion Date
Feb 17, 2023Actual
Completion Date
Feb 17, 2023Actual
First Submitted Date
Aug 24, 2020
First Submission Date that Met QC Criteria
Aug 26, 2020
First Posted Date
Aug 27, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Feb 16, 2024
Results First Submitted that Met QC Criteria
Sep 19, 2024
Results First Posted Date
Sep 25, 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
Oct 28, 2024
Last Update Posted Date
Nov 20, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PATHOTHER
Collaborators
Name
Class
Bill and Melinda Gates Foundation
OTHER
Centers for Disease Control and Prevention
FED
Viroclinics Biosciences B.V.
INDUSTRY
The Emmes Company, LLC
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral poliomyelitis vaccine type 1 (nOPV1) and novel oral poliomyelitis vaccine type 3 (nOPV3), as compared to Sabin strain monovalent oral poliomyelitis vaccine (mOPV) controls, in healthy adults.
Detailed Description
This multicenter trial is the first-in-human assessment of two novel oral polio vaccines for poliovirus type 1 and type 3. It will be a 4-cohort, 8-arm, randomized, observer-blind, controlled trial, with Sabin monovalent vaccines serving as the control for each type:
Cohort 1: Healthy adults with an exclusive inactivated poliovirus vaccine (IPV) prior vaccination history will be randomized in a 1:1 ratio and allocated to receive nOPV1 (Group 1) or mOPV1 (Group 2).
Cohort 2: Healthy adults with an OPV-containing prior vaccination history will be randomized in a 2:1 ratio and allocated to receive two doses of nOPV1 (Group 3) or mOPV1 (Group 4), respectively;
Cohort 3: Healthy adults with an exclusive IPV prior vaccination history will be randomized in a 1:1 ratio and allocated to receive nOPV3 (Group 5) or mOPV3 (Group 6);
Cohort 4: Healthy adults with an OPV-containing prior vaccination history will be randomized in a 2:1 ratio to study groups 3 and 4 and allocated to receive two doses of nOPV3 (Group 7) or mOPV3 (Group 8), respectively.
Conditions Module
Conditions
Poliomyelitis
Keywords
Vaccine tolerability
Vaccine reactogenicity
Vaccine viral shedding
Vaccine immunogenicity
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
226Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group1: nOPV1 (IPV History)
Experimental
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of novel OPV type 1 (nOPV1) containing 10^6.5 cell culture infectious dose 50% (CCID50) on Day 1.
Biological: Novel Oral Polio Vaccine Type 1 (nOPV1)
Group 2: mOPV1 (IPV History)
Active Comparator
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of mOPV1 containing 10^6.0 CCID50 on Day 1.
Biological: Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)
Group 3: nOPV1 (OPV History)
Experimental
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
Biological: Novel Oral Polio Vaccine Type 1 (nOPV1)
Group 4: mOPV1 (OPV History)
Active Comparator
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
Biological: Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)
Group 5: nOPV3 (IPV History)
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Novel Oral Polio Vaccine Type 1 (nOPV1)
Biological
Each 0.1 mL (2 drops) dose of vaccine contains approximately 10^6.5 CCID50.
Group 3: nOPV1 (OPV History)
Group1: nOPV1 (IPV History)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Serious Adverse Events (SAEs)
A serious adverse event is any adverse event that resulted in any of the following outcomes:
Death
Was life-threatening
Required inpatient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
Congenital anomaly or birth defect
Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and/or require medical or surgical intervention to prevent one of the outcomes listed above
From Day 1 to end of study, up to 169 days
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. Solicited AEs for this study included:
Fever (oral temperature ≥ 38.0°C or 100.4°F)
Chills
Fatigue
Headache
Muscle aches/myalgias
Joint aches/arthralgias
Nausea
Vomiting
Abdominal pain
Diarrhea
From vaccination to 7 days post vaccination (Days 1-7)
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. Solicited AEs for this study included:
Fever (oral temperature ≥ 38.0°C or 100.4°F)
Chills
Fatigue
Headache
Muscle aches/myalgias
Joint aches/arthralgias
Nausea
Vomiting
Abdominal pain
Diarrhea
From Day 29 to Day 35
Number of Participants With Unsolicited Adverse Events (AEs) up to 28 Days Post Vaccination
Unsolicited AEs are any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents.
In the absence of a diagnosis, abnormal physical examination findings or abnormal clinical safety laboratory test results that are assessed by the investigator to be clinically significant were reported as an AE.
Secondary Outcomes
Measure
Description
Time Frame
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Blood samples collected from participants for type-specific poliovirus neutralizing antibodies were analyzed at the Polio and Picornavirus Laboratory Branch at the United States Centers for Disease Control and Prevention (CDC).
For all immunogenicity endpoints, data are presented separately by:
Prior vaccination history (exclusively IPV vs OPV), and
Type-specific poliovirus vaccine received (type 1 vs type 3).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment
Healthy, as defined by the absence of any clinically significant medical conditions, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator
Willing and able to provide written informed consent prior to performance of any study-specific procedure
If female and of childbearing potential*, be not breastfeeding and not pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to any study vaccination), agreeing to have repeated pregnancy tests prior to any study vaccination, and having practiced adequate contraception** for 30 days prior to first study vaccination and willing to continue using adequate contraception consistently for at least 90 days after the last study vaccination and until cessation of vaccine virus shedding is confirmed
* Females can be considered not of childbearing potential if they are with current bilateral tubal ligation, occlusion or removal, or post-total hysterectomy, or post-bilateral ovariectomy
** Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example:
Abstinence from penile-vaginal intercourse
Combined estrogen and progesterone oral contraceptives
Hormonal (e.g., progestogen) injections
Hormonal (e.g., etonogestrel or levonorgestrel) implants
Contraceptive vaginal ring
Percutaneous contraceptive patches
Intrauterine device
Intrauterine hormonal system
Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository), and/or progesterone alone oral contraceptive
Monogamous relationship with vasectomized (≥ 180 days prior to enrollment) partner
Resides in study area and is able and willing to adhere to all study restrictions and to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator)
Agrees not to and has no plans to travel outside the United States (US) until confirmation of cessation of vaccine virus shedding in stool at or after the study Day 57 stool collection
Able and willing to be contacted by telephone or text, and willing for study staff to leave telephone voice or electronic messages as needed
Neutralizing antibody titer ≥ 1:8 for poliovirus type 1 (for participants in cohorts 1 and 2) and ≥ 1:8 for poliovirus type 3 (for participants in cohorts 3 and 4)
For Cohorts 1 and 3 only: previously received at least 3 doses of IPV and with no history of receipt of OPV. For Cohorts 2 and 4 only: previously received a primary polio immunization series containing OPV
Exclusion Criteria:
Have any condition (medical, psychiatric or behavioral) that, in the opinion of the investigator, would increase the participant's health risks in study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments)
Receipt of polio vaccine within 12 months before the start of the study
Having Crohn's disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel
A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin)
Any confirmed or suspected immunosuppressive or immunodeficiency condition (human immunodeficiency virus [HIV] infection, or total serum immunoglobulin A (IgA) or immunoglobulin G (IgG) level below the testing laboratory's lower limit of normal [LLN])
Administration of any long-acting immune-modifying drugs (e.g., infliximab or rituximab) or the chronic administration (i.e., longer than 14 days) of immunosuppressant drugs (e.g., oral or systemic steroids) or other immune-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study (inhaled and topical steroids are allowed whereas intraarticular and epidural injection/administration of steroids are not allowed)
Will have household direct or close professional contact during the study with individuals expected to be immunosuppressed (due to underlying condition or treatments) or individuals who have not yet completed their primary infant polio immunization series (i.e., three doses)
Will have household direct or close professional contact during the study with pregnant women
Will have household direct or close professional (e.g., neonatal nurses) contact during the study with children less than 2 years of age or with individuals who are encopretic (i.e., infants/toddlers who are not yet toilet trained or other individuals, including adults, with fecal incontinence)
Will have professional handling of food, catering, or food production activities during the study
Reside in homes with septic tanks
Acute illness or fever (body temperature measured orally ≥ 38°C or 100.4°F) at the time of study vaccine administration (once acute illness/fever is resolved, if appropriate, as per investigator assessment, participant may complete screening)
Indications of drug abuse or excessive use of alcohol as deemed by the investigator to confound safety assessments or render the participant unable or unlikely to adhere to protocol requirements or provide accurate safety reports
Participation in another investigational product (drug or vaccine) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days prior to the first administration of study vaccine, or planned use during the study period
Administration of any vaccine (except seasonal inactivated influenza and COVID-19 vaccines which are prohibited for only 14 days prior to or following each study vaccination) other than the study vaccine or any intramuscular injection within 30 days prior to the first dose of study vaccine or planned administration within 30 days prior to or after any study vaccination.
Receipt of transfusion of any blood product or application of immunoglobulins within the 12 weeks prior to the first administration of study vaccine or planned use during the study period
Hepatitis B or C virus infection
Any hematological# or chemistry** parameter that is out of range of normal†† and is considered clinically significant by the investigator
#Complete blood count (CBC), includes hemoglobin, hematocrit, white blood cell (WBC) count, neutrophil count, lymphocyte count, eosinophil count, and platelet count
**Creatinine, alanine transaminase (ALT), total bilirubin
††Per the site clinical laboratory's reference ranges. All tests with out of range results that are regarded as clinically significant by the clinician must be repeated and determined to be not clinically significant before any participant can be enrolled.
The following hematological or chemistry laboratory results will be considered exclusionary, irrespective of assessment of clinical significance:
Hemoglobin (Male) < 12.5 g/dL
Hemoglobin (Female) < 11.0 g/dL
Neutrophil count < 1,000 cells/mm^3
Eosinophil count > 650 cells/mm^3
Platelet count < 125,000 cells/mm^3
Creatinine > 1.4 mg/dL
ALT > 1.1 X upper limit of normal (ULN) (per the site clinical laboratory's reference ranges)
Mercer LD, Sena AC, Colgate ER, Crothers JW, Wright PF, Al-Ibrahim M, Tritama E, Vincent A, Mainou BA, Zhang Y, Konopka-Anstadt J, Bandyopadhyay AS, Fix A, Konz JO, Gast C. Safety and immunogenicity of novel live attenuated type 1 and type 3 oral poliomyelitis vaccines in healthy adults in the USA: a first-in-human, observer-masked, multicentre, phase 1 randomised controlled trial. Lancet Infect Dis. 2025 Dec;25(12):1363-1376. doi: 10.1016/S1473-3099(25)00285-3. Epub 2025 Aug 13.
Cohorts 1 and 2 received vaccine against poliovirus type 1 and Cohorts 3 and 4 received vaccine against poliovirus type 3.
In Cohorts 1 and 3 participants with an exclusive IPV vaccination history were randomized in a 1:1 ratio to receive novel oral poliomyelitis vaccine (nOPV) or Sabin strain monovalent oral poliomyelitis vaccine (mOPV) control.
In Cohorts 2 and 4, participants with an OPV-containing vaccination history were randomized in a 2:1 ratio to receive nOPV or mOPV.
Recruitment Details
Healthy volunteers were enrolled at four study sites in the United States. This study consisted of 4 cohorts, each with 2 groups of participants.
Participants must have received either prior vaccination with at least 3 doses of inactivated poliovirus vaccine (IPV) with no history of receipt of oral poliomyelitis vaccine (OPV) (Cohorts 1 and 3) or previously received a primary polio immunization series containing OPV (Cohorts 2 and 4).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of novel oral polio vaccine type 1 (nOPV1) containing 10^6.5 cell culture infectious dose 50% (CCID50) on Day 1.
FG001
Group 2: mOPV1 (IPV History)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
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
Feb 17, 2022
Feb 16, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
INDUSTRY
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
It will be an 8-arm, randomized, observer-blind, controlled trial
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
Biological: Novel Oral Polio Vaccine Type 3 (nOPV3)
Group 6: mOPV3 (IPV History)
Active Comparator
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
Biological: Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)
Group 7: nOPV3 (OPV History)
Experimental
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 in a dose of 10^6.5 CCID50/dose, given 28 days apart.
Biological: Novel Oral Polio Vaccine Type 3 (nOPV3)
Group 8: mOPV3 (OPV History)
Active Comparator
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
Biological: Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)
Novel Oral Polio Vaccine Type 3 (nOPV3)
Biological
Each 0.1 mL (2 drops) dose of vaccine contains approximately 10^6.5 CCID50.
Group 5: nOPV3 (IPV History)
Group 7: nOPV3 (OPV History)
Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)
Biological
The Sabin mOPV1 control vaccine contains ≥ 10^6.0 CCID50 per 0.1 mL (2 drops) dose.
Group 2: mOPV1 (IPV History)
Group 4: mOPV1 (OPV History)
Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)
Biological
the Sabin mOPV3 control vaccine contains ≥ 10^5.8 CCID50 per 0.1 mL (2 drops) dose.
Group 6: mOPV3 (IPV History)
Group 8: mOPV3 (OPV History)
Sabin monovalent oral polio vaccine type 3
From vaccination to 28 days post vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination)
Baseline and Day 29 (28 days post-vaccination)
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Baseline, Day 29 (28 days post-vaccination) and Day 57 (28 days after 2nd vaccination)
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Baseline and Day 29 (28 days post-vaccination)
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Baseline, Day 29 (28 days after the 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Geometric Mean Titer (GMT) of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
GMT and 95% confidence intervals are maximum likelihood estimates incorporating left and right censoring at the lower limit of quantitation (LLOQ) and ULOQ, respectively.
Baseline and Day 29 (28 days post-vaccination)
Geometric Mean Titer of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Baseline and Day 29 (28 days post-vaccination)
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Baseline (pre-vaccination) and Day 29 (28 days post-vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Baseline, Day 29 (28 days post-vaccination) and Day 57 (28 days after 2nd vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Baseline and Day 29 (28 days post-vaccination)
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With IPV Vaccination History
The presence of the vaccine virus in stool samples was assessed using polymerase chain reaction (PCR). Time to cessation of shedding is defined as the time between vaccination and the last PCR-positive stool prior to 2 consecutive PCR-negative stools (with a minimum 24-hour interval between the 2 negative stools). The time to cessation of fecal shedding of nOPV1 and nOPV3 in prior IPV recipients was estimated using Kaplan-Meier methodology with interval-censoring.
Up to Day 57
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With OPV Vaccination History
The presence of the vaccine virus in stool samples was assessed using polymerase chain reaction (PCR). Time to cessation of shedding is defined as the time between vaccination and the last PCR-positive stool prior to 2 consecutive PCR-negative stools (with a minimum 24-hour interval between the 2 negative stools). The time to cessation of fecal shedding of nOPV1 and nOPV3 in prior OPV recipients was evaluated separately after each dose, estimated using Kaplan-Meier methodology with interval-censoring.
From vaccination through 28 days after each vaccination
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Presence of the vaccine virus in stool samples was assessed by polymerase chain reaction (PCR).
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Presence of the vaccine virus in stool samples was assessed by polymerase chain reaction (PCR).
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Samples positive for vaccine virus in stool as detected by PCR were quantified using a cell culture infectious dose assay. Participants who were PCR-positive for type 1 viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Samples positive for vaccine virus in stool as detected by PCR were quantified using a cell culture infectious dose assay. Participants who were PCR-positive for type 3 viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
Shedding Index of Vaccine Virus Shedding in Stool in Participants With IPV Vaccination History
The Shedding Index Endpoint (SIE) was computed as the mean of the log₁₀ cell culture infectious dose 50% (CCID50) per gram from nominal collection days 7, 14, 21, and 28 post-dose (i.e., study days 8, 15, 22, and 29). Participants who were PCR-positive for type-specific viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Days 8, 15, 22, and 29
Area Under the Curve From Vaccination to 28 Days After Vaccination (AUC₀-₂₈) of Vaccine Virus Shed in Stool in Participants With an IPV Vaccination History
Area under the curve (AUC) was computed for each participant using CCID50 per gram data collected through Day 29 using the linear trapezoidal rule. Participants were assumed to be not shedding at time of vaccination (i.e. there was no stool collection on Day 1). Participants who were PCR-positive for type-specific viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Days 3, 5, 8, 10, 15, 22, and 29
Lebanon
New Hampshire
03756
United States
University of North Carolina Institute for Global Health and Infectious Diseases (IGHID)
Chapel Hill
North Carolina
27599-7215
United States
University of Vermont Vaccine Testing Center
Burlington
Vermont
05405
United States
Derived
Thompson KM, Kalkowska DA, Kidd SE, Burns CC, Badizadegan K. Trade-offs of different poliovirus vaccine options for outbreak response in the United States and other countries that only use inactivated poliovirus vaccine (IPV) in routine immunization. Vaccine. 2024 Feb 6;42(4):819-827. doi: 10.1016/j.vaccine.2023.12.081. Epub 2024 Jan 12.
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin monovalent oral polio vaccine type 1 (mOPV1) containing 10^6.0 CCID50 on Day 1.
FG002
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
FG003
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
FG004
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of novel oral poliomyelitis vaccine type 3 (nOPV3) containing 10^6.5 CCID50 on Day 1.
FG005
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin monovalent oral polio vaccine type 3 (mOPV3) containing ≥ 10^5.8 CCID50 on Day 1.
FG006
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
FG007
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
FG00021 subjects
FG00123 subjects
FG00253 subjects
FG00327 subjects
FG00420 subjects
FG00521 subjects
FG00640 subjects
FG00721 subjects
Received 1st Vaccination
FG00020 subjects
FG00120 subjects
FG00250 subjects
FG00325 subjects
FG00419 subjects
FG00517 subjects
FG00635 subjects
FG00719 subjects
Received 2nd Vaccination
FG0000 subjectsNot applicable as participants previously vaccinated with IPV only received 1 vaccination in this study
FG0010 subjectsNot applicable as participants previously vaccinated with IPV only received 1 vaccination in this study
FG00249 subjects
FG00322 subjects
FG0040 subjectsNot applicable as participants previously vaccinated with IPV only received 1 vaccination in this study
FG0050 subjectsNot applicable as participants previously vaccinated with IPV only received 1 vaccination in this study
FG00635 subjects
FG00718 subjects
COMPLETED
FG00018 subjects
FG00118 subjects
FG00249 subjects
FG00322 subjects
FG00419 subjects
FG00517 subjects
FG00635 subjects
FG00719 subjects
NOT COMPLETED
FG0003 subjects
FG0015 subjects
FG0024 subjects
FG0035 subjects
FG0041 subjects
FG0054 subjects
FG0065 subjects
FG0072 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
Not eligible at enrollment
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Safety Population was defined as all participants who provided informed consent and who received a study vaccine, and for whom no potential transmission events between participants were identified by next generation sequencing of shed virus (Cohorts 1 and 3 only).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
BG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
BG002
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
BG003
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
BG004
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
BG005
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
BG006
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
BG007
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00018
BG00118
BG00250
BG00325
BG00419
BG00515
BG00635
BG00719
BG008199
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00020.8± 2.6
BG00120.0± 1.6
BG00230.0± 6.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG0019
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Number of Participants With Serious Adverse Events (SAEs)
A serious adverse event is any adverse event that resulted in any of the following outcomes:
Death
Was life-threatening
Required inpatient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
Congenital anomaly or birth defect
Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and/or require medical or surgical intervention to prevent one of the outcomes listed above
The Reactogenicity Population was defined as all participants who provided informed consent and received a study vaccine.
Posted
Count of Participants
Participants
From Day 1 to end of study, up to 169 days
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
OG002
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
OG003
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
OG004
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG005
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
OG006
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
OG007
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
Units
Counts
Participants
OG00020
OG00120
OG00250
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Solicited Adverse Events (AEs) 7 Days After First Dose of Study Vaccine
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. Solicited AEs for this study included:
Fever (oral temperature ≥ 38.0°C or 100.4°F)
Chills
Fatigue
Headache
Muscle aches/myalgias
Joint aches/arthralgias
Nausea
Vomiting
Abdominal pain
Diarrhea
The Reactogenicity Population was defined as all participants who provided informed consent and received a study vaccine.
Posted
Count of Participants
Participants
From vaccination to 7 days post vaccination (Days 1-7)
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
OG002
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
Primary
Number of Participants With Solicited Adverse Events 7 Days After Second Dose of Study Vaccine
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity. Solicited AEs for this study included:
Fever (oral temperature ≥ 38.0°C or 100.4°F)
Chills
Fatigue
Headache
Muscle aches/myalgias
Joint aches/arthralgias
Nausea
Vomiting
Abdominal pain
Diarrhea
The Reactogenicity Population was defined as all participants who provided informed consent and received a study vaccine. The analysis includes groups / participants who received a 2nd vaccination.
Posted
Count of Participants
Participants
From Day 29 to Day 35
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
OG002
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
Primary
Number of Participants With Unsolicited Adverse Events (AEs) up to 28 Days Post Vaccination
Unsolicited AEs are any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents.
In the absence of a diagnosis, abnormal physical examination findings or abnormal clinical safety laboratory test results that are assessed by the investigator to be clinically significant were reported as an AE.
Reactogenicity population; the analysis includes participants who received each vaccination
Posted
Count of Participants
Participants
From vaccination to 28 days post vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination)
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
OG002
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
Secondary
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
Blood samples collected from participants for type-specific poliovirus neutralizing antibodies were analyzed at the Polio and Picornavirus Laboratory Branch at the United States Centers for Disease Control and Prevention (CDC).
For all immunogenicity endpoints, data are presented separately by:
Prior vaccination history (exclusively IPV vs OPV), and
Type-specific poliovirus vaccine received (type 1 vs type 3).
The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point.
The analysis includes groups with prior IPV history who received vaccination with a type 1 OPV.
Posted
Median
95% Confidence Interval
log₂ titer
Baseline and Day 29 (28 days post-vaccination)
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
Secondary
Median Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point.
The analysis includes groups with prior OPV history who received vaccination with a type 1 OPV.
Posted
Median
95% Confidence Interval
log₂ titer
Baseline, Day 29 (28 days post-vaccination) and Day 57 (28 days after 2nd vaccination)
ID
Title
Description
OG000
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
OG001
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
Units
Secondary
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point.
The analysis includes groups with prior IPV history who received vaccination with a type 3 OPV.
Posted
Median
95% Confidence Interval
log₂ titer
Baseline and Day 29 (28 days post-vaccination)
ID
Title
Description
OG000
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG001
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
Units
Counts
Participants
Secondary
Median Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point.
The analysis includes groups with prior OPV history who received vaccination with a type 3 OPV.
Posted
Median
95% Confidence Interval
log₂ titer
Baseline, Day 29 (28 days after the 1st vaccination) and Day 57 (28 days after 2nd vaccination)
ID
Title
Description
OG000
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
OG001
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
Units
Secondary
Geometric Mean Titer (GMT) of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
GMT and 95% confidence intervals are maximum likelihood estimates incorporating left and right censoring at the lower limit of quantitation (LLOQ) and ULOQ, respectively.
The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point.
The analysis includes groups with prior IPV history who received vaccination with a type 1 OPV.
Posted
Geometric Mean
95% Confidence Interval
titer
Baseline and Day 29 (28 days post-vaccination)
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
Secondary
Geometric Mean Titer of Anti-poliovirus Type 1 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point.
The analysis includes groups with prior OPV history who received vaccination with a type 1 OPV.
Posted
Geometric Mean
95% Confidence Interval
titer
Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
ID
Title
Description
OG000
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
OG001
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
Secondary
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of IPV
The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point.
The analysis includes groups with prior IPV history who received vaccination with a type 3 OPV.
Posted
Geometric Mean
95% Confidence Interval
titer
Baseline and Day 29 (28 days post-vaccination)
ID
Title
Description
OG000
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG001
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
Units
Counts
Participants
Secondary
Geometric Mean Titer of Anti-poliovirus Type 3 Serum Neutralizing Antibodies at Baseline and Post-vaccination Among Participants With a Vaccine History of OPV
The Per-Protocol Population (PPP) for immunogenicity was defined as all participants in the Reactogenicity Population who provided a baseline and at least 1 post-vaccination evaluable serum sample and who received correct study vaccinations per randomization with no major protocol deviations that might interfere with the immunogenicity result. The PPP was determined separately for each time point.
The analysis includes groups with prior OPV history who received vaccination with a type 3 OPV.
Posted
Geometric Mean
95% Confidence Interval
titer
Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
ID
Title
Description
OG000
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
OG001
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
Secondary
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Per Protocol Population. The analysis includes groups with prior IPV history who received vaccination with a type 1 OPV; participants were only included in each analysis if the appropriate measure could be observed based on Baseline neutralizing antibody titer.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline (pre-vaccination) and Day 29 (28 days post-vaccination)
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Secondary
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 1 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Per Protocol Population; The analysis includes groups with prior OPV history who received vaccination with a type 1 OPV; participants were only included in each analysis if the appropriate measure could be observed based on Baseline neutralizing antibody titer.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline, Day 29 (28 days post-vaccination) and Day 57 (28 days after 2nd vaccination)
ID
Title
Description
OG000
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
OG001
Secondary
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Vaccination Among Participants With a Vaccine History of IPV
Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Per Protocol Population. The analysis includes groups with prior IPV history who received vaccination with a type 3 OPV; participants were only included in each analysis if the appropriate measure could be observed based on Baseline neutralizing antibody titer.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline and Day 29 (28 days post-vaccination)
ID
Title
Description
OG000
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG001
Group 6: mOPV3 (IPV History)
Secondary
Percentage of Participants With Any-Fold Rise, 2-fold Rise and 4-fold Rise in Anti-poliovirus Type 3 Serum Neutralizing Antibody Titers From Baseline to 28 Days After Each Vaccination Among Participants With a Vaccine History of OPV
Seroconversion (SCR) is defined as a minimum 4-fold increase in titer from Baseline (pre-vaccination) to 28 days post-vaccination among those participants with a 4-fold increase possible to observe, i.e., with a Baseline titer not greater than 8.5 log₂.
Minimum 2-fold-rise from Baseline to 28 days post-vaccination among those participants with a 2-fold increase possible to observe, i.e., with a Baseline titer not greater than 9.5 log₂.
Any fold-rise is defined as any increase in titer from Baseline to 28 days post-vaccination (log₂ neutralizing antibody titer post-dose minus Baseline > 0), among those with an increase possible to observe, i.e., with a Baseline titer less than 10.5 log₂.
Per Protocol Population; The analysis includes groups with prior OPV history who received vaccination with a type 3 OPV; participants were only included in each analysis if the appropriate measure could be observed based on Baseline neutralizing antibody titer.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline, Day 29 (28 days after 1st vaccination) and Day 57 (28 days after 2nd vaccination)
ID
Title
Description
OG000
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
OG001
Secondary
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With IPV Vaccination History
The presence of the vaccine virus in stool samples was assessed using polymerase chain reaction (PCR). Time to cessation of shedding is defined as the time between vaccination and the last PCR-positive stool prior to 2 consecutive PCR-negative stools (with a minimum 24-hour interval between the 2 negative stools). The time to cessation of fecal shedding of nOPV1 and nOPV3 in prior IPV recipients was estimated using Kaplan-Meier methodology with interval-censoring.
Participants in the Safety Population with available PCR data; the analysis includes groups with prior IPV history.
Posted
Median
95% Confidence Interval
days
Up to Day 57
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
OG002
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
Secondary
Time to Cessation of Fecal Shedding of Vaccine Virus in Participants With OPV Vaccination History
The presence of the vaccine virus in stool samples was assessed using polymerase chain reaction (PCR). Time to cessation of shedding is defined as the time between vaccination and the last PCR-positive stool prior to 2 consecutive PCR-negative stools (with a minimum 24-hour interval between the 2 negative stools). The time to cessation of fecal shedding of nOPV1 and nOPV3 in prior OPV recipients was evaluated separately after each dose, estimated using Kaplan-Meier methodology with interval-censoring.
Participants in the Safety Population with available PCR data at each time point; the analysis includes groups with prior OPV history.
Posted
Median
95% Confidence Interval
days
From vaccination through 28 days after each vaccination
ID
Title
Description
OG000
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
OG001
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
OG002
Secondary
Percentage of Participants Shedding Type 1 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Presence of the vaccine virus in stool samples was assessed by polymerase chain reaction (PCR).
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Participants in the Safety Population with available PCR data at each time point. The analysis includes groups with prior IPV history who received vaccination with a type 1 OPV.
Posted
Number
95% Confidence Interval
percentage of participants
Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
Units
Counts
Participants
Secondary
Percentage of Participants Shedding Type 3 Vaccine Virus at Each Post-vaccination Stool Collection in Participants With IPV Vaccination History
Presence of the vaccine virus in stool samples was assessed by polymerase chain reaction (PCR).
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Participants in the Safety Population with available PCR data at each time point. The analysis includes groups with prior IPV history who received vaccination with a type 3 OPV
Posted
Number
95% Confidence Interval
percentage of participants
Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
ID
Title
Description
OG000
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG001
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
Units
Counts
Participants
Secondary
Amount of Type 1 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Samples positive for vaccine virus in stool as detected by PCR were quantified using a cell culture infectious dose assay. Participants who were PCR-positive for type 1 viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Participants in the Safety population who were PCR-positive for poliovirus type 1 viral shedding and with available CCID50 data. The analysis includes groups with prior IPV history who received vaccination with a type 1 OPV.
Posted
Median
95% Confidence Interval
log₁₀ CCID50 per gram
Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
Units
Secondary
Amount of Type 3 Vaccine Virus in Each Stool Sample Positive for Virus in Participants With IPV Vaccination History
Samples positive for vaccine virus in stool as detected by PCR were quantified using a cell culture infectious dose assay. Participants who were PCR-positive for type 3 viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Participants in the Safety population who were PCR-positive for poliovirus type 3 viral shedding. The analysis includes groups with prior IPV history who received vaccination with a type 3 OPV.
Posted
Median
95% Confidence Interval
log₁₀ CCID50 per gram
Days 3, 5, 8, 10, 15, 22, 29, 36, 43, 50, and 57
ID
Title
Description
OG000
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG001
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
Units
Counts
Secondary
Shedding Index of Vaccine Virus Shedding in Stool in Participants With IPV Vaccination History
The Shedding Index Endpoint (SIE) was computed as the mean of the log₁₀ cell culture infectious dose 50% (CCID50) per gram from nominal collection days 7, 14, 21, and 28 post-dose (i.e., study days 8, 15, 22, and 29). Participants who were PCR-positive for type-specific viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Participants with complete data at all four time points (Days 8, 15, 22, and 29) were included in the analysis. The analysis includes groups with prior IPV history.
Posted
Median
95% Confidence Interval
log₁₀ CCID50 per gram
Days 8, 15, 22, and 29
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
OG002
Group 5: nOPV3 (IPV History)
Secondary
Area Under the Curve From Vaccination to 28 Days After Vaccination (AUC₀-₂₈) of Vaccine Virus Shed in Stool in Participants With an IPV Vaccination History
Area under the curve (AUC) was computed for each participant using CCID50 per gram data collected through Day 29 using the linear trapezoidal rule. Participants were assumed to be not shedding at time of vaccination (i.e. there was no stool collection on Day 1). Participants who were PCR-positive for type-specific viral shedding but with log₁₀ CCID50 per gram ≤ LLOQ contributed a value equal to the LLOQ.
This endpoint was pre-specified to be analyzed in participants with IPV vaccination history.
Participants with available CCID50/g shedding data (must have data from Day 3 and Day 29, and no 2 missing consecutive samples from Days 5, 8, 10, 15, and 22). The analysis includes groups with prior IPV history.
Posted
Median
95% Confidence Interval
days * log₁₀ CCID50/gram
Days 3, 5, 8, 10, 15, 22, and 29
ID
Title
Description
OG000
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
OG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
Time Frame
All-cause mortality and serious AEs were collected up to Day 169. Non-serious AEs were collected up to 28 days after each vaccination (Day 1-28 for 1st vaccination and Day 29-56 for the 2nd vaccination). Solicited AEs were collected up to 7 days after each vaccination (Days 1-7 for 1st vaccination and Days 29-35 for the 2nd vaccination).
Description
All-cause mortality is reported for all randomized participants. AEs are reported for the Reactogenicity Population, defined as all participants who provided informed consent and received a study vaccine.
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
Group1: nOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV1 containing 10^6.5 CCID50 on Day 1.
0
21
0
20
13
20
EG001
Group 2: mOPV1 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
0
23
0
20
13
20
EG002
Group 3: nOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV1 containing 10^6.5 CCID50/dose, given 28 days apart.
0
53
0
50
39
50
EG003
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
0
27
0
25
21
25
EG004
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
0
20
0
19
12
19
EG005
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
0
21
0
17
10
17
EG006
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
0
40
0
35
15
35
EG007
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
0
21
0
19
12
19
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0005 affected20 at risk
EG0018 affected20 at risk
EG00221 affected50 at risk
EG00311 affected25 at risk
EG0047 affected19 at risk
EG0058 affected17 at risk
EG0069 affected35 at risk
EG0077 affected19 at risk
Chills
General disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0015 affected20 at risk
EG0023 affected50 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected50 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 affected20 at risk
EG0014 affected20 at risk
EG00211 affected50 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0005 affected20 at risk
EG0015 affected20 at risk
EG0027 affected50 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0012 affected20 at risk
EG0028 affected50 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected50 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0012 affected20 at risk
EG0020 affected50 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0005 affected20 at risk
EG0017 affected20 at risk
EG00216 affected50 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Migraine
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected20 at risk
EG0020 affected50 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected20 at risk
EG0020 affected50 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0016 affected20 at risk
EG00210 affected50 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0014 affected20 at risk
EG0024 affected50 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
COVID-19
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0010 affected20 at risk
EG0022 affected50 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Candida infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Fungal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Kidney infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0025 affected50 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected50 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected20 at risk
EG0020 affected50 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0011 affected20 at risk
EG0020 affected50 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected50 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected20 at risk
EG0022 affected50 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
White blood cell count decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0002 affected20 at risk
EG0011 affected20 at risk
EG0021 affected50 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Skin mass
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0022 affected50 at risk
EG003
Immunisation reaction
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0021 affected50 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Wisdom teeth removal
Surgical and medical procedures
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Tonsilitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected20 at risk
EG0011 affected20 at risk
EG0020 affected50 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Muscle weakness
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected20 at risk
EG0010 affected20 at risk
EG0020 affected50 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The only disclosure restriction on the PI is that there should be a joint publication first; after the joint publication or after 24 months without a joint publication from the time of last participant last visit, the PI has a right to present the trial results at meetings or do their own publication in a journal, but they must provide PATH the chance to review the manuscript 60 days in advance of publication.
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
OG004
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG005
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
OG006
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
OG007
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
Units
Counts
Participants
OG00020
OG00120
OG00250
OG00325
OG00419
OG00517
OG00635
OG00719
Title
Denominators
Categories
Any Solicited Event
Title
Measurements
OG00011
OG00112
OG00225
OG00315
OG00410
OG0059
OG00613
OG0077
Fever
Title
Measurements
OG0000
OG0010
OG0020
OG003
Chills
Title
Measurements
OG0001
OG0015
OG0021
OG003
Fatigue
Title
Measurements
OG0005
OG0018
OG00217
OG003
Headache
Title
Measurements
OG0005
OG0017
OG00210
OG003
Muscle Aches/Myalgias
Title
Measurements
OG0002
OG0016
OG0026
OG003
Joint Aches/Arthralgias
Title
Measurements
OG0001
OG0014
OG0022
OG003
Nausea
Title
Measurements
OG0002
OG0012
OG0026
OG003
Vomiting
Title
Measurements
OG0000
OG0012
OG0020
OG003
Abdominal pain
Title
Measurements
OG0005
OG0015
OG0024
OG003
Diarrhea
Title
Measurements
OG0002
OG0014
OG0029
OG003
OG003
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
OG004
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG005
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
OG006
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
OG007
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
Units
Counts
Participants
OG0000
OG0010
OG00249
OG00322
OG0040
OG0050
OG00635
OG00718
Title
Denominators
Categories
Any Solicited Event
Title
Measurements
OG00216
OG00312
OG0066
OG0077
Fever
Title
Measurements
OG0021
OG0030
OG0060
OG007
Chills
Title
Measurements
OG0021
OG0032
OG0060
OG007
Fatigue
Title
Measurements
OG0028
OG0036
OG0061
OG007
Headache
Title
Measurements
OG0029
OG0035
OG0063
OG007
Muscle Aches/Myalgias
Title
Measurements
OG0024
OG0033
OG0061
OG007
Joint Aches/Arthralgias
Title
Measurements
OG0021
OG0034
OG0061
OG007
Nausea
Title
Measurements
OG0023
OG0032
OG0063
OG007
Vomiting
Title
Measurements
OG0020
OG0031
OG0061
OG007
Abdominal pain
Title
Measurements
OG0024
OG0032
OG0061
OG007
Diarrhea
Title
Measurements
OG0024
OG0034
OG0063
OG007
OG003
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
OG004
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG005
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
OG006
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
OG007
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
Units
Counts
Participants
OG00020
OG00120
OG00250
OG00325
OG00419
OG00517
OG00635
OG00719
Title
Denominators
Categories
After 1st dose
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG00250
ParticipantsOG00325
ParticipantsOG00419
ParticipantsOG00517
ParticipantsOG00635
ParticipantsOG00719
Title
Measurements
OG0007
OG0017
OG00221
OG003
After 2nd dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00249
ParticipantsOG00322
Units
Counts
Participants
OG00018
OG00115
Title
Denominators
Categories
Baseline
Title
Measurements
OG0005.67(5.34 to 7.33)
OG0016.00(5.83 to 7.50)
Day 29
Title
Measurements
OG000NA(NA to NA)Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
OG001NA(NA to NA)Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
Counts
Participants
OG00048
OG00123
Title
Denominators
Categories
Baseline
ParticipantsOG00048
ParticipantsOG00123
Title
Measurements
OG0006.83(6.17 to 7.83)
OG0017.17(5.50 to 8.17)
Day 29
ParticipantsOG00048
ParticipantsOG00123
Title
Measurements
OG000NA(NA to NA)Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
OG001
Day 57
ParticipantsOG00047
ParticipantsOG00122
Title
Measurements
OG000NA(NA to NA)Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
OG001
OG00019
OG00115
Title
Denominators
Categories
Baseline
Title
Measurements
OG0006.17(5.83 to 8.17)
OG0016.17(5.50 to 6.83)
Day 29
Title
Measurements
OG000NA(NA to NA)Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
OG001NA(9.50 to NA)Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
Counts
Participants
OG00035
OG00119
Title
Denominators
Categories
Baseline
ParticipantsOG00035
ParticipantsOG00119
Title
Measurements
OG0005.83(4.17 to 6.83)
OG0016.50(5.17 to 8.50)
Day 29
ParticipantsOG00034
ParticipantsOG00119
Title
Measurements
OG000NA(NA to NA)Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
OG001
Day 57
ParticipantsOG00034
ParticipantsOG00117
Title
Measurements
OG000NA(NA to NA)Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
OG001
Units
Counts
Participants
OG00018
OG00115
Title
Denominators
Categories
Baseline
Title
Measurements
OG00049.6(26.7 to 92.1)
OG00173.2(33.6 to 159.7)
Day 29
Title
Measurements
OG0005208.2(904.6 to 29986.4)
OG0012846.7(716.6 to 11307.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of Type 1 neutralizing antibody GMT at Day 29
GMT Ratio
0.68
2-Sided
95
0.252
1.838
GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.
Other
Units
Counts
Participants
OG00048
OG00123
Title
Denominators
Categories
Baseline
ParticipantsOG00048
ParticipantsOG00123
Title
Measurements
OG000111.6(70.5 to 176.5)
OG001116.0(48.1 to 280.1)
Day 29
ParticipantsOG00048
ParticipantsOG00123
Title
Measurements
OG00010869.2(1953.5 to 60474.3)
OG001
Day 57
ParticipantsOG00047
ParticipantsOG00122
Title
Measurements
OG0004407.5(1547.8 to 12551.0)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of type 1 neutralizing antibody GMT at Day 29
GMT Ratio
1.26
2-Sided
95
0.232
6.833
GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.
Other
OG000
OG001
Comparison of type 1 neutralizing antibody GMT at Day 57
GMT Ratio
1.98
2-Sided
95
0.603
6.528
GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.
Other
OG00019
OG00115
Title
Denominators
Categories
Baseline
Title
Measurements
OG000113.0(56.7 to 225.2)
OG00174.6(43.2 to 128.8)
Day 29
Title
Measurements
OG0003091.2(1095.6 to 8721.9)
OG0013945.5(736.6 to 21132.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of type 3 neutralizing antibody GMT at Day 29
GMT Ratio
1.56
2-Sided
95
0.639
3.828
GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.
Other
Units
Counts
Participants
OG00035
OG00119
Title
Denominators
Categories
Baseline
ParticipantsOG00035
ParticipantsOG00119
Title
Measurements
OG00053.4(29.1 to 97.8)
OG001101.1(47.7 to 214.5)
Day 29
ParticipantsOG00034
ParticipantsOG00119
Title
Measurements
OG0002810.1(1364.0 to 5789.3)
OG001
Day 57
ParticipantsOG00034
ParticipantsOG00117
Title
Measurements
OG0003337.0(1293.1 to 8611.7)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Comparison of type 3 neutralizing antibody GMT at Day 29
GMT Ratio
1.79
2-Sided
95
0.772
4.163
GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.
Other
OG000
OG001
Comparison of type 3 neutralizing antibody GMT at Day 57
GMT Ratio
2.51
2-Sided
95
0.994
6.340
GMT ratios (nOPV/mOPV) were estimated via a linear model of the log₂ neutralizing antibody titer as a function of group with a fixed parameter for site and a covariate for the baseline log₂ neutralizing antibody titer level.
Other
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of Sabin mOPV1 containing 10^6.0 CCID50 on Day 1.
Units
Counts
Participants
OG00018
OG00114
Title
Denominators
Categories
≥ 4-fold rise
Title
Measurements
OG00088.9(65.29 to 98.62)
OG00192.9(66.13 to 99.82)
≥ 2-fold rise
Title
Measurements
OG00094.4(72.71 to 99.86)
OG001100(76.84 to 100)
Any fold-rise
Title
Measurements
OG000100(81.47 to 100)
OG001100(76.84 to 100)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Between-Group Seroconversion Rate (4-fold rise) in Neutralizing Antibody Titers
Fisher Exact
>0.999
Rate Difference
-4.0
2-Sided
95
-27.67
22.72
Rate Difference = nOPV - mOPV
Other
Group 4: mOPV1 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 doses of Sabin mOPV1 containing ≥ 10^6.0 CCID50/dose, given 28 days apart.
Units
Counts
Participants
OG00047
OG00120
Title
Denominators
Categories
Day 29: ≥ 4-fold rise
ParticipantsOG00036
ParticipantsOG00118
Title
Measurements
OG00086.1(70.50 to 95.33)
OG00188.9(65.29 to 98.62)
Day 29: ≥ 2-fold rise
ParticipantsOG00042
ParticipantsOG00120
Title
Measurements
OG00083.3(68.64 to 93.03)
OG001
Day 29: Any fold-rise
ParticipantsOG00047
ParticipantsOG00120
Title
Measurements
OG00083.0(69.19 to 92.35)
OG001
Day 57: ≥ 4-fold rise
ParticipantsOG00035
ParticipantsOG00118
Title
Measurements
OG00097.1(85.08 to 99.93)
OG001
Day 57: ≥ 2-fold rise
ParticipantsOG00041
ParticipantsOG00119
Title
Measurements
OG00095.1(83.47 to 99.40)
OG001
Day 57: Any fold-rise
ParticipantsOG00046
ParticipantsOG00119
Title
Measurements
OG00097.8(88.47 to 99.94)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.
Fisher Exact
>0.999
Rate Difference
-2.8
2-Sided
95
-20.47
20.86
Rate Difference = nOPV - mOPV
Other
OG000
OG001
Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.
Fisher Exact
0.263
Rate Difference
8.3
2-Sided
95
-5.71
30.57
Rate Difference = nOPV - mOPV
Other
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
Units
Counts
Participants
OG00018
OG00115
Title
Denominators
Categories
≥ 4-fold rise
ParticipantsOG00015
ParticipantsOG00114
Title
Measurements
OG000100(78.20 to 100)
OG00185.7(57.9 to 98.22)
≥ 2-fold rise
ParticipantsOG00017
ParticipantsOG00115
Title
Measurements
OG00094.1(71.31 to 99.85)
OG001
Any fold-rise
ParticipantsOG00018
ParticipantsOG00115
Title
Measurements
OG00094.4(72.71 to 99.86)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Between-group seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after vaccination
Fisher Exact
0.224
Rate Difference
14.3
2-Sided
95
-8.30
40.45
Rate Difference = nOPV - mOPV
Other
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
Units
Counts
Participants
OG00034
OG00118
Title
Denominators
Categories
Day 29: ≥ 4-fold rise
ParticipantsOG00028
ParticipantsOG00115
Title
Measurements
OG00096.4(81.65 to 99.91)
OG00186.7(59.54 to 98.34)
Day 29: ≥ 2-fold rise
ParticipantsOG00032
ParticipantsOG00118
Title
Measurements
OG00096.9(83.78 to 99.92)
OG001
Day 29: Any fold-rise
ParticipantsOG00034
ParticipantsOG00118
Title
Measurements
OG00094.1(80.32 to 99.28)
OG001
Day 57: ≥ 4-fold rise
ParticipantsOG00028
ParticipantsOG00114
Title
Measurements
OG00096.4(81.65 to 99.91)
OG001
Day 57: ≥ 2-fold rise
ParticipantsOG00034
ParticipantsOG00117
Title
Measurements
OG00090.6(74.98 to 98.02)
OG001
Day 57: Any fold-rise
ParticipantsOG00032
ParticipantsOG00117
Title
Measurements
OG000100(89.72 to 100)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after first dose.
Fisher Exact
0.275
Rate Difference
9.8
2-Sided
95
-7.29
35.19
Rate Difference = nOPV - mOPV
Other
OG000
OG001
Between-group comparison of seroconversion rate (4-fold rise) in neutralizing antibody titers 28 days after 2nd dose.
Fisher Exact
0.100
Rate Difference
17.9
2-Sided
95
-1.27
44.93
Rate Difference = nOPV - mOPV
Other
OG003
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
Units
Counts
Participants
OG00018
OG00118
OG00219
OG00315
Title
Denominators
Categories
Title
Measurements
OG00022(15 to 24)
OG00120(20 to 29)
OG00220(15 to 37)
OG00329(22 to 42)
Group 7: nOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of nOPV3 containing 10^6.5 CCID50/dose, given 28 days apart.
OG003
Group 8: mOPV3 (OPV History)
Healthy adults fully vaccinated against polio with an OPV-containing vaccine history were administered 2 vaccinations of mOPV3 containing ≥ 10^5.8 CCID50/dose, given 28 days apart.
Units
Counts
Participants
OG00050
OG00125
OG00235
OG00319
Title
Denominators
Categories
After first dose
ParticipantsOG00050
ParticipantsOG00125
ParticipantsOG00235
ParticipantsOG00319
Title
Measurements
OG00020(9 to 20)
OG00120(14 to 20)
OG00221(13 to NA)Could not be calculated due to low numbers of participants with positive shedding results
OG003
After 2nd dose
ParticipantsOG00049
ParticipantsOG00122
ParticipantsOG00235
ParticipantsOG00318
OG00018
OG00118
Title
Denominators
Categories
Day 3
ParticipantsOG00016
ParticipantsOG00117
Title
Measurements
OG00062.5(35.4 to 84.8)
OG00182.4(56.6 to 96.2)
Day 5
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG00093.3(68.1 to 99.8)
OG001
Day 8
ParticipantsOG00017
ParticipantsOG00118
Title
Measurements
OG000100(80.5 to 100)
OG001
Day 10
ParticipantsOG00017
ParticipantsOG00116
Title
Measurements
OG000100(80.5 to 100)
OG001
Day 15
ParticipantsOG00017
ParticipantsOG00116
Title
Measurements
OG00094.1(71.3 to 99.9)
OG001
Day 22
ParticipantsOG00018
ParticipantsOG00116
Title
Measurements
OG00050.0(26.0 to 74.0)
OG001
Day 29
ParticipantsOG00018
ParticipantsOG00115
Title
Measurements
OG00022.2(6.4 to 47.6)
OG001
Day 36
ParticipantsOG00013
ParticipantsOG00115
Title
Measurements
OG00030.8(9.1 to 61.4)
OG001
Day 43
ParticipantsOG00015
ParticipantsOG00115
Title
Measurements
OG0000.0(0.0 to 21.8)
OG001
Day 50
ParticipantsOG00018
ParticipantsOG00114
Title
Measurements
OG0000.0(0.0 to 18.5)
OG001
Day 57
ParticipantsOG00016
ParticipantsOG00114
Title
Measurements
OG0000.0(0.0 to 20.6)
OG001
At any time point
ParticipantsOG00018
ParticipantsOG00118
Title
Measurements
OG000100(81.5 to 100)
OG001
OG00019
OG00115
Title
Denominators
Categories
Day 3
ParticipantsOG00017
ParticipantsOG00114
Title
Measurements
OG00088.2(63.6 to 98.5)
OG00171.4(41.9 to 91.6)
Day 5
ParticipantsOG00017
ParticipantsOG00112
Title
Measurements
OG000100(80.5 to 100)
OG001
Day 8
ParticipantsOG00017
ParticipantsOG00114
Title
Measurements
OG000100(80.5 to 100)
OG001
Day 10
ParticipantsOG00016
ParticipantsOG00113
Title
Measurements
OG00093.8(69.8 to 99.8)
OG001
Day 15
ParticipantsOG00017
ParticipantsOG00115
Title
Measurements
OG00076.5(50.1 to 93.2)
OG001
Day 22
ParticipantsOG00018
ParticipantsOG00113
Title
Measurements
OG00038.9(17.3 to 64.3)
OG001
Day 29
ParticipantsOG00018
ParticipantsOG00114
Title
Measurements
OG00038.9(17.3 to 64.3)
OG001
Day 36
ParticipantsOG00018
ParticipantsOG00112
Title
Measurements
OG00027.8(9.7 to 53.5)
OG001
Day 43
ParticipantsOG00017
ParticipantsOG00114
Title
Measurements
OG00011.8(1.5 to 36.4)
OG001
Day 50
ParticipantsOG00017
ParticipantsOG00114
Title
Measurements
OG0000.0(0.0 to 19.5)
OG001
Day 57
ParticipantsOG00017
ParticipantsOG00115
Title
Measurements
OG0000.0(0.0 to 19.5)
OG001
At any time point
ParticipantsOG00019
ParticipantsOG00115
Title
Measurements
OG000100(82.4 to 100)
OG001
Counts
Participants
OG00018
OG00118
Title
Denominators
Categories
Day 3
ParticipantsOG00010
ParticipantsOG00114
Title
Measurements
OG0002.94(2.750 to 3.875)
OG0013.22(2.750 to 4.211)
Day 5
ParticipantsOG00014
ParticipantsOG00113
Title
Measurements
OG0003.22(2.922 to 4.125)
OG001
Day 8
ParticipantsOG00017
ParticipantsOG00118
Title
Measurements
OG0003.41(2.813 to 4.000)
OG001
Day 10
ParticipantsOG00017
ParticipantsOG00116
Title
Measurements
OG0003.19(2.938 to 3.719)
OG001
Day 15
ParticipantsOG00016
ParticipantsOG00113
Title
Measurements
OG0002.75(2.750 to 2.813)
OG001
Day 22
ParticipantsOG0009
ParticipantsOG0017
Title
Measurements
OG0002.75(2.750 to 3.219)
OG001
Day 29
ParticipantsOG0004
ParticipantsOG0014
Title
Measurements
OG0002.77(2.750 to 2.781)
OG001
Day 36
ParticipantsOG0004
ParticipantsOG0012
Title
Measurements
OG0002.75(2.750 to 3.313)
OG001
Day 43
ParticipantsOG0000
ParticipantsOG0011
Title
Measurements
OG0013.34(3.34 to 3.34)
Day 50
ParticipantsOG0000
ParticipantsOG0010
Day 57
ParticipantsOG0000
ParticipantsOG0010
Participants
OG00019
OG00115
Title
Denominators
Categories
Day 3
ParticipantsOG00015
ParticipantsOG00110
Title
Measurements
OG0004.06(2.938 to 4.750)
OG0014.00(2.781 to 4.734)
Day 5
ParticipantsOG00017
ParticipantsOG00112
Title
Measurements
OG0003.88(2.906 to 4.500)
OG001
Day 8
ParticipantsOG00017
ParticipantsOG00114
Title
Measurements
OG0004.28(3.094 to 4.594)
OG001
Day 10
ParticipantsOG00015
ParticipantsOG00113
Title
Measurements
OG0004.16(2.844 to 4.375)
OG001
Day 15
ParticipantsOG00013
ParticipantsOG00114
Title
Measurements
OG0002.84(2.750 to 3.063)
OG001
Day 22
ParticipantsOG0007
ParticipantsOG0018
Title
Measurements
OG0002.75(2.750 to 2.781)
OG001
Day 29
ParticipantsOG0007
ParticipantsOG0017
Title
Measurements
OG0002.75(2.750 to 2.813)
OG001
Day 36
ParticipantsOG0005
ParticipantsOG0014
Title
Measurements
OG0002.78(2.750 to 3.281)
OG001
Day 43
ParticipantsOG0002
ParticipantsOG0011
Title
Measurements
OG0002.77(2.750 to 2.781)
OG001
Day 50
ParticipantsOG0000
ParticipantsOG0011
Title
Measurements
OG0012.81(2.81 to 2.81)
Day 57
ParticipantsOG0000
ParticipantsOG0011
Title
Measurements
OG0013.78(3.78 to 3.78)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG003
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
Units
Counts
Participants
OG00016
OG00113
OG00214
OG00311
Title
Denominators
Categories
Title
Measurements
OG0001.88(1.477 to 2.344)
OG0011.96(1.734 to 2.477)
OG0022.20(1.844 to 3.016)
OG0032.41(1.766 to 3.578)
OG002
Group 5: nOPV3 (IPV History)
Healthy adults fully vaccinated against polio exclusively by IPV were administered 1 vaccination of nOPV3 containing 10^6.5 CCID50 on Day 1.
OG003
Group 6: mOPV3 (IPV History)
Healthy adults fully vaccinated against polio by exclusively IPV were administered 1 vaccination of Sabin mOPV3 containing ≥ 10^5.8 CCID50 on Day 1.
Units
Counts
Participants
OG00015
OG00115
OG00217
OG00312
Title
Denominators
Categories
Title
Measurements
OG00057.84(10.188 to 66.625)
OG00166.88(52.797 to 78.344)
OG00260.80(49.172 to 80.438)
OG00371.46(56.711 to 87.945)
3 affected
25 at risk
EG0041 affected19 at risk
EG0050 affected17 at risk
EG0061 affected35 at risk
EG0071 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0051 affected17 at risk
EG0060 affected35 at risk
EG0071 affected19 at risk
10 affected
25 at risk
EG0043 affected19 at risk
EG0057 affected17 at risk
EG0065 affected35 at risk
EG0075 affected19 at risk
4 affected
25 at risk
EG0046 affected19 at risk
EG0051 affected17 at risk
EG0065 affected35 at risk
EG0072 affected19 at risk
3 affected
25 at risk
EG0041 affected19 at risk
EG0051 affected17 at risk
EG0068 affected35 at risk
EG0071 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0061 affected35 at risk
EG0071 affected19 at risk
2 affected
25 at risk
EG0041 affected19 at risk
EG0050 affected17 at risk
EG0061 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0071 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
10 affected
25 at risk
EG0043 affected19 at risk
EG0056 affected17 at risk
EG0068 affected35 at risk
EG0075 affected19 at risk
0 affected
25 at risk
EG0041 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
6 affected
25 at risk
EG0042 affected19 at risk
EG0052 affected17 at risk
EG0062 affected35 at risk
EG0072 affected19 at risk
6 affected
25 at risk
EG0041 affected19 at risk
EG0052 affected17 at risk
EG0062 affected35 at risk
EG0071 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
2 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0061 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0041 affected19 at risk
EG0051 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0061 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0071 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0061 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0041 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
2 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0061 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0061 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0061 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
2 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0041 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0041 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
2 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0071 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0041 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
1 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0071 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0 affected
25 at risk
EG0040 affected19 at risk
EG0050 affected17 at risk
EG0060 affected35 at risk
EG0070 affected19 at risk
0
OG0040
OG0050
OG0060
OG0070
1
OG0041
OG0050
OG0061
OG0070
9
OG0047
OG0057
OG0069
OG0075
7
OG0043
OG0055
OG0066
OG0073
3
OG0042
OG0052
OG0061
OG0072
2
OG0041
OG0052
OG0061
OG0071
2
OG0041
OG0051
OG0068
OG0070
1
OG0041
OG0050
OG0060
OG0070
3
OG0046
OG0051
OG0065
OG0072
6
OG0043
OG0056
OG0063
OG0073
1
1
3
2
1
0
1
0
0
3
10
OG0044
OG0051
OG0063
OG0072
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG00635
ParticipantsOG00718
Title
Measurements
OG00216
OG0037
OG0062
OG0073
NA
(10.17 to NA)
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
NA
(NA to NA)
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
NA
(9.50 to NA)
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
9.83
(9.17 to NA)
Titers above upper limit of quantitation (ULOQ) (10.5 log₂)
4495.1
(960.9 to 21027.0)
16500.8
(808.4 to 336813.5)
1483.8
(758.8 to 2901.4)
1076.8
(613.5 to 1890.0)
90.0
(68.30 to 98.77)
100
(83.16 to 100)
88.9
(65.29 to 98.62)
94.7
(73.97 to 99.87)
94.7
(73.97 to 99.87)
100
(78.20 to 100)
100
(78.20 to 100)
83.3
(58.58 to 96.42)
94.4
(72.71 to 99.86)
78.6
(49.20 to 95.34)
76.5
(50.10 to 93.19)
88.2
(63.56 to 98.54)
17
(8 to NA)
Could not be calculated due to low numbers of participants with positive shedding results
Title
Measurements
OG0005(NA to NA)Could not be calculated due to low numbers of participants with positive shedding results
OG0017(4 to 7)
OG0022(NA to NA)Could not be calculated due to low numbers of participants with positive shedding results
OG0032(NA to NA)Could not be calculated due to low numbers of participants with positive shedding results