A Study to Evaluate the Safety and Immunogenicity of MEDI... | NCT02289820 | Trialant
NCT02289820
Sponsor
MedImmune LLC
Status
Completed
Last Update Posted
Mar 15, 2018Actual
Enrollment
363Actual
Phase
Phase 1
Conditions
Respiratory Syncytial Virus (RSV)
Interventions
MEDI7510
IIV
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT02289820
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D4420C00004
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults
Official Title
A Phase 1b Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults
Acronym
Not provided
Organization
MedImmune LLCINDUSTRY
Status Module
Record Verification Date
Feb 2018
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
Jan 5, 2015Actual
Primary Completion Date
Feb 24, 2016Actual
Completion Date
Feb 24, 2016Actual
First Submitted Date
Nov 10, 2014
First Submission Date that Met QC Criteria
Nov 10, 2014
First Posted Date
Nov 13, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 30, 2017
Results First Submitted that Met QC Criteria
Aug 7, 2017
Results First Posted Date
Feb 19, 2018Actual
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
Feb 16, 2018
Last Update Posted Date
Mar 15, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedImmune LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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 goal of this study is to evaluate the safety, tolerability and immunogenicity of ascending doses of adjuvant in combination with a single dosage level of RSV sF in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions. This study will also provide preliminary safety and immunogenicity data to support concurrent dosing of MEDI7510 with influenza vaccine (IIV), and to assess the safety of MEDI7510 at a dose previously assessed in the Phase 1a study.
Detailed Description
A Phase 1b, double-blind, randomized, controlled cohort escalation study evaluating the safety, tolerability and immunogenicity of MEDI7510.
Approximately 264 subjects will be enrolled at approximately 5 study centers in the US and randomized by cohort (Cohort 1 [4:1]; Cohorts 2 and 3 [8:8:3]; Cohort 4 [5:1]) to receive a single intramuscular dose of 1 study vaccine (Cohorts 1 and 4) or a single intramuscular dose of each of 2 study vaccines (Cohorts 2 and 3) administered in contralateral arms.
Cohort 1: MEDI7510 formulation (n = 40) or IIV (n = 10) Cohort 2: MEDI7510 formulation and placebo (n = 40) or MEDI7510 formulation and IIV (n = 40) or placebo and IIV (n = 15) Cohort 3: MEDI7510 formulation and placebo (n = 40) or MEDI7510 formulation and IIV (n = 40) or placebo and IIV (n = 15) Cohort 4: MEDI7510 formulation (n = 20) or IIV (n = 4)
Conditions Module
Conditions
Respiratory Syncytial Virus (RSV)
Keywords
RSV
Older adults
MEDI7510
Vaccine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
363Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Experimental
Participants will receive a single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
Biological: MEDI7510
MEDI7510 (120 mcg sF + 2.5 mcg GLA), Cohort 2
Experimental
Participants will receive a single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV or MEDI7510 plus placebo administered by IM injection in contralateral arms on Day 1.
Biological: MEDI7510
Biological: IIV
MEDI7510 (120 mcg sF + 5 mcg GLA), Cohort 3
Experimental
Participants will receive a single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV or MEDI7510 plus placebo administered by IM injection in contralateral arms on Day 1.
Biological: MEDI7510
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Experimental
Participants will receive a single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
Biological: MEDI7510
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI7510
Biological
RSV sF antigen plus adjuvant
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
MEDI7510 (120 mcg sF + 2.5 mcg GLA), Cohort 2
MEDI7510 (120 mcg sF + 5 mcg GLA), Cohort 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Solicited Symptoms
Solicited symptoms are events that are considered likely to occur post dosing and included the local reaction (pain, tenderness or soreness, redness, and swelling at the site of injection) to investigational product (IP) injection and systemic symptoms (fever greater than or equal to [>=] 100.4°F [>=38°C] by any route, headache, generalized muscle aches, and fatigue or tiredness) that might be related to IP injection. Solicited symptoms were not coded using Medical Dictionary for Regulatory Activities (MedDRA) and summarized regardless of whether or not they are treatment emergent. The percentage of participants with solicited symptoms were recorded during Days 1 (day of dosing) through 7.
Day 1 to Day 7
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent were the events between administration of study drug and including the follow-up period through Day 29. The AEs were summarized using the Medical Dictionary for Regulatory Activities version 18.1.
From Day 1 to Day 29
Percentage of Participants With Treatment-emergent Serious Adverse Events
A serious adverse event (SAE) was an AE resulting in any of following reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk), persistent or significant disability/incapacity, congenital anomaly, and a medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.
From Day 1 to Day 361
Percentage of Participants With New Onset Chronic Diseases (NOCDs)
A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. All NOCDs were recorded from the time of dosing through the day of the last participant contact (Day 361 visit).
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
GMTs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay at Baseline and the results through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A. Immunogenicity population is defined as all participants in ATP who had no protocol deviation judged to have the potential to interfere with generation or interpretation of an immune response.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age greater than or equal to 60 years
Ambulatory or ambulatory with assistance (not institutionalized, bedridden, or homebound)
Weight greater than 90 lbs
Hemoglobin greater than or equal to 10.5 g/dL for women and greater than or equal to 11 g/dL for men
Subject able to complete follow-up period of 360 days after dosing
Exclusion Criteria:
History of allergy to: any component of the vaccine; IIV or intolerance of IIV; eggs in adulthood
Receipt of seasonal flu shot within 60 days prior to dosing
Any unstable acute or chronic medical condition, including one that has resulted in change in therapy (medication or other) in the 30 days prior to randomization or hospitalization in the previous year or might be predicted to result in hospitalization in the year after enrollment. Subjects with severe, untreated or uncontrolled underlying medical disease that might either compromise subject safety or affect the ability to assess safety of the investigational product are excluded. Medications taken on an as-needed basis are permitted to start or stop during the 30 days prior to randomization unless they are medications not previously taken by the subject
Clinically significant abnormalities in screening laboratory assessments or screening ECG
Cognitive disorder such that informed consent cannot be obtained directly from the subject
Previous vaccination against RSV
History of or current autoimmune disorder
Immunosuppression caused by disease, including human immunodeficiency virus (HIV) infection, or medications. Any oral prednisone dosing within 30 days of enrollment or planned dosing within the 360-day follow-up period would disqualify. Expected need for immunosuppressive medications during the 360-day follow-up period would disqualify
History of splenectomy or of condition affecting splenic function (eg, hemoglobinopathy)
History of cancer within preceding 5 years other than treated non-melanoma skin cancer
Body Mass Index 40 or higher
Receipt of any nonstudy vaccine within 30 days prior to study dosing or expected receipt of nonstudy vaccine within 30 days after study dosing
Receipt of any investigational product in the 90 days prior to randomization or expected receipt of investigational product during the period of study follow-up
Receipt of immunoglobulins or blood products within 4 months of study dosing (120 days) or expected receipt of investigational product during the period of study follow-up
Current bleeding or clotting disorder including use of anticoagulants other than drugs with anti-platelet activity (such as nonsteroidal anti-inflammatory drugs, clopidogrel, ticagrelor or aspirin)
Expected receipt of antipyretic or analgesic medication on a daily or every other day basis from randomization through 72 hours after receipt of IP (Note: A daily dose of aspirin is not considered a contraindication to enrollment.)
Subjects who have significant scarring, tattoos, abrasions, cuts, or infections over the deltoid region of both arms that, in the investigators opinion, could interfere with evaluation of injection site local reactions
Concurrent enrollment in another clinical study that involves any invasive clinical procedure, including phlebotomy
History of alcohol or drug abuse or psychiatric disorder that, in the investigators opinion, would affect the subject's safety or compliance with study
Employees of individuals directly involved with the conduct of the study, individuals who themselves are involved with the conduct of the study, or immediate family members of such individuals
Chang LA, Phung E, Crank MC, Morabito KM, Villafana T, Dubovsky F, Falloon J, Esser MT, Lin BC, Chen GL, Graham BS, Ruckwardt TJ. A prefusion-stabilized RSV F subunit vaccine elicits B cell responses with greater breadth and potency than a postfusion F vaccine. Sci Transl Med. 2022 Dec 21;14(676):eade0424. doi: 10.1126/scitranslmed.ade0424. Epub 2022 Dec 21.
A total of 264 participants were enrolled in the study. Of the 264 randomized participants, 3 participants did not receive the study drug. 261 participants were included in the As-treated Population.
Recruitment Details
A total of 363 participants were screened. Of these, 264 participants were enrolled.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
FG001
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
FG002
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
FG003
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
FG004
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
FG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
FG006
MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00039 subjects
FG00120 subjects
FG00244 subjects
FG00339 subjects
FG00440 subjects
FG00540 subjects
FG00639 subjects
COMPLETED
FG00037 subjects
FG00118 subjects
FG00238 subjects
FG00337 subjects
FG004
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0026 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Percentage of Participants With Solicited Symptoms
Solicited symptoms are events that are considered likely to occur post dosing and included the local reaction (pain, tenderness or soreness, redness, and swelling at the site of injection) to investigational product (IP) injection and systemic symptoms (fever greater than or equal to [>=] 100.4°F [>=38°C] by any route, headache, generalized muscle aches, and fatigue or tiredness) that might be related to IP injection. Solicited symptoms were not coded using Medical Dictionary for Regulatory Activities (MedDRA) and summarized regardless of whether or not they are treatment emergent. The percentage of participants with solicited symptoms were recorded during Days 1 (day of dosing) through 7.
As-treated Population (ATP) included all participants who received any amount of study drug.
Posted
Number
Percentage of Participants
Day 1 to Day 7
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Adverse Events Module
Frequency Threshold
0
Time Frame
AEs and SAEs were collected from time of signature of informed consent throughout the treatment period and including the follow-up period through the Day 29 visit and day of last subject contact (Day 361 visit), respectively
Description
Not provided
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
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac arrest
Cardiac disorders
MedDRA 18.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 18.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Judith Falloon, MD, FACP, FIDSA, Senior Director, Clinical Development
MedImmune LLC
+1-301-398-4010
information.center@astrazeneca.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Inactivated Influenza Vaccine (IIV)
Active Comparator
Participants will receive a single dose of IIV by intramuscular injection in contralateral arms on Day 1.
Biological: IIV
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
IIV
Biological
Marketed Inactivated Influenza Vaccine
Inactivated Influenza Vaccine (IIV)
MEDI7510 (120 mcg sF + 2.5 mcg GLA), Cohort 2
From Day 1 to Day 361
Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through the day of the last participant contact (Day 361 visit).
From Day 1 to Day 361
Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361
Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay
GMFRs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay from Baseline line through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.
Day 29, 61, 91, 181, 271, and 361
Percentage of Participants With Post-dose Seroresponse to RSV by RSV A Microneutralization Assay
Seroresponse defined as a greater than or equal to (>=) 3-fold rise in titer from baseline. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.
Day 29
Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay
Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.
Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361
GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay
The Anti F IgG antibodies were derived from the RSV-specific 4-plex MSD assay developed on the Meso Scale discovery platform. Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.
Day 29, 61, 91, 181, 271, and 361
Percentage of Participants With Post-dose Seroresponse to RSV by Anti-F IgG Assay
Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline. Humoral immunity against RSV was assessed by an Anti-F IgG assay derived from the RSV-specific 4-plex MSD assay.
Day 29
Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies
The ratio of post-dose HAI antibody GMTs and GMFRs in the IIV group and the MEDI7510 plus IIV group was provided by strain and by cohort for Cohorts 2 and 3 to check the effect of MEDI7510 on IIV when administered together. Humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed on Day 29 by each strain (H1N1, H3N2, B/Yamagata).
Day 29
Geometric Mean Counts of Cellular Immune Response Against RSV by Respiratory Syncytial Virus Fusion Protein (RSV F) Interferon Gamma (IFNγ) Enzyme-linked Immunosorbent Spot (ELISPOT) Assay
The Geometric Mean Counts assessed by the ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples.
Baseline (Day 1) and Day 8
GMFRs of Cellular Immune Response Against RSV by RSV F IFNγ ELISPOT Assay
The GMFRs assessed by the ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples
Day 8
Percentage of Participants With Post-dose Cell-mediated Immune Response to RSV F by RSV F Peptide Pool IFNγ ELISPOT
Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline. The Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples.
Day 8
South Miami
Florida
United States
Research Site
Kansas City
Missouri
United States
Research Site
Raleigh
North Carolina
United States
Research Site
Nashville
Tennessee
United States
Derived
Falloon J, Talbot HK, Curtis C, Ervin J, Krieger D, Dubovsky F, Takas T, Yu J, Yu L, Lambert SL, Villafana T, Esser MT. Dose Selection for an Adjuvanted Respiratory Syncytial Virus F Protein Vaccine for Older Adults Based on Humoral and Cellular Immune Responses. Clin Vaccine Immunol. 2017 Sep 5;24(9):e00157-17. doi: 10.1128/CVI.00157-17. Print 2017 Sep.
40 subjects
FG00539 subjects
FG00637 subjects
0 subjects
FG0051 subjects
FG0062 subjects
1 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
withdrawal of consent
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
BG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
BG003
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
BG004
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
BG005
MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
BG006
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
BG007
Total
Total of all reporting groups
39
BG00144
BG00239
BG00340
BG00440
BG00539
BG00620
BG007261
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00070.5± 6.9
BG00169.6± 7.0
BG00269.3± 5.2
BG00367.9± 5.8
BG00470.1± 5.9
BG00570.2± 6.8
BG00668.9± 6.5
BG00769.5± 6.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00021
BG00125
BG00227
BG00319
BG00418
BG00519
BG00613
BG007142
Male
BG00018
BG00119
BG00212
BG00321
BG004
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00138
OG00240
OG00320
OG00444
OG00540
OG00638
Title
Denominators
Categories
Title
Measurements
OG00035.9
OG00173.7
OG00260.0
OG00360.0
OG00463.6
OG00575.0
OG00668.4
Primary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent were the events between administration of study drug and including the follow-up period through Day 29. The AEs were summarized using the Medical Dictionary for Regulatory Activities version 18.1.
ATP included all participants who received any amount of study drug.
Posted
Number
Percentage of Participants
From Day 1 to Day 29
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.1
OG00115.4
OG00222.5
OG003
Primary
Percentage of Participants With Treatment-emergent Serious Adverse Events
A serious adverse event (SAE) was an AE resulting in any of following reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk), persistent or significant disability/incapacity, congenital anomaly, and a medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.
ATP included all participants who received any amount of study drug.
Posted
Number
Percentage of Participants
From Day 1 to Day 361
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.6
OG0015.1
OG0020
OG003
Primary
Percentage of Participants With New Onset Chronic Diseases (NOCDs)
A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. All NOCDs were recorded from the time of dosing through the day of the last participant contact (Day 361 visit).
ATP included all participants who received any amount of study drug.
Posted
Number
Percentage of Participants
From Day 1 to Day 361
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.6
OG0010
OG0025.0
OG003
Primary
Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)
An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through the day of the last participant contact (Day 361 visit).
ATP included all participants who received any amount of study drug.
Posted
Number
Percentage of Participants
From Day 1 to Day 361
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay
GMTs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay at Baseline and the results through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A. Immunogenicity population is defined as all participants in ATP who had no protocol deviation judged to have the potential to interfere with generation or interpretation of an immune response.
Immunogenicity population
Posted
Geometric Mean
95% Confidence Interval
Titers
Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG003
Title
Denominators
Categories
Baseline (Day 1)
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG003
Secondary
Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay
GMFRs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay from Baseline line through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.
Immunogenicity Population. Here, 'n' is number of participants analyzed for this outcome measure at given time points.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
Day 29, 61, 91, 181, 271, and 361
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG003
Title
Denominators
Categories
Day 29
ParticipantsOG00039
ParticipantsOG00138
ParticipantsOG00240
ParticipantsOG003
Secondary
Percentage of Participants With Post-dose Seroresponse to RSV by RSV A Microneutralization Assay
Seroresponse defined as a greater than or equal to (>=) 3-fold rise in titer from baseline. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.
Immunogenicity population.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 29
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG00041.0(25.57 to 57.90)
OG00142.1(26.31 to 59.18)
OG00242.5(27.04 to 59.11)
OG003
Secondary
Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay
Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.
Immunogenicity Population. Here, 'n' is number of participants analyzed for this outcome measure at given time points.
Posted
Geometric Mean
95% Confidence Interval
F Ab Unit/mL
Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG003
Title
Denominators
Categories
Baseline (Day 1)
ParticipantsOG00039
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG003
Secondary
GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay
The Anti F IgG antibodies were derived from the RSV-specific 4-plex MSD assay developed on the Meso Scale discovery platform. Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.
Immunogenicity Population. Here, 'n' is number of participants analyzed for this outcome measure at given time points.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
Day 29, 61, 91, 181, 271, and 361
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG003
Title
Denominators
Categories
Day 29
ParticipantsOG00039
ParticipantsOG00138
ParticipantsOG00240
ParticipantsOG003
Secondary
Percentage of Participants With Post-dose Seroresponse to RSV by Anti-F IgG Assay
Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline. Humoral immunity against RSV was assessed by an Anti-F IgG assay derived from the RSV-specific 4-plex MSD assay.
Immunogenicity population.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 29
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00039
OG00139
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG00094.9(82.68 to 99.37)
OG00189.5(75.20 to 97.06)
OG00290.0(76.34 to 97.21)
OG003
Secondary
Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies
The ratio of post-dose HAI antibody GMTs and GMFRs in the IIV group and the MEDI7510 plus IIV group was provided by strain and by cohort for Cohorts 2 and 3 to check the effect of MEDI7510 on IIV when administered together. Humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed on Day 29 by each strain (H1N1, H3N2, B/Yamagata).
Immunogenicity Population.
Posted
Number
95% Confidence Interval
Ratio
Day 29
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00038
OG00140
OG00240
OG003
Title
Denominators
Categories
GMT: H1N1
Title
Measurements
OG000NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0011.19(0.71 to 1.99)
OG002
Secondary
Geometric Mean Counts of Cellular Immune Response Against RSV by Respiratory Syncytial Virus Fusion Protein (RSV F) Interferon Gamma (IFNγ) Enzyme-linked Immunosorbent Spot (ELISPOT) Assay
The Geometric Mean Counts assessed by the ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples.
Immunogenicity Population. Here, 'n' is number of participants analyzed for this outcome measure at given time points.
Posted
Geometric Mean
95% Confidence Interval
Spot forming counts per 10^6 PBMCs
Baseline (Day 1) and Day 8
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00038
OG00137
OG00234
OG003
Title
Denominators
Categories
Baseline (Day 1)
ParticipantsOG00034
ParticipantsOG00132
ParticipantsOG00233
ParticipantsOG003
Secondary
GMFRs of Cellular Immune Response Against RSV by RSV F IFNγ ELISPOT Assay
The GMFRs assessed by the ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples
Immunogenicity Population.
Posted
Geometric Mean
95% Confidence Interval
Fold rise
Day 8
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00034
OG00126
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.45(4.88 to 8.52)
OG0016.77(4.13 to 11.09)
OG0028.67(6.38 to 11.78)
OG003
Secondary
Percentage of Participants With Post-dose Cell-mediated Immune Response to RSV F by RSV F Peptide Pool IFNγ ELISPOT
Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline. The Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples.
Immunogenicity Population.
Posted
Number
95% Confidence Interval
Percentage of Participants
Day 8
ID
Title
Description
OG000
MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1
Participants received single dose of MEDI7510 (120 microgram [mcg] respiratory syncytial virus [RSV] soluble fusion protein [sF] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1.
OG001
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
OG003
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
OG004
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
OG005
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
OG006
MEDI7510 (120 mcg sF + 5 mcg GLA) + IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
Units
Counts
Participants
OG00034
OG00126
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG00076.5(58.83 to 89.25)
OG00180.8(60.65 to 93.45)
OG00290.0(73.47 to 97.89)
OG003
1
39
2
39
EG001
Inactivated Influenza Vaccine (IIV)
Participants received single dose of IIV by intramuscular injection in contralateral arms on Day 1.
1
44
8
44
EG002
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + Placebo, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
2
39
5
39
EG003
MEDI7510 (120 mcg sF + 2.5 mcg GLA) + IIV, Cohort 2
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
0
40
9
40
EG004
MEDI7510 (120 mcg sF + 5 mcg GLA) + Placebo, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus placebo administered by IM injection in contralateral arms on Day 1.
0
40
11
40
EG005
MEDI7510 (120 mcg sF + 5 mcg GLA)+ IIV, Cohort 3
Participants received single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV administered by IM injection in contralateral arms on Day 1.
1
39
8
39
EG006
MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4
Participants received single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1.
0
20
6
20
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Breast cancer female
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Rectal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Angina pectoris
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Coronary artery disease
Cardiac disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected20 at risk
Blepharospasm
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Iridocyclitis
Eye disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Dental caries
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Nausea
Gastrointestinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected20 at risk
Axillary pain
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Fatigue
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected20 at risk
Injection site reaction
General disorders
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Pyrexia
General disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Cellulitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Gastroenteritis viral
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Herpes zoster
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Laryngitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Nasopharyngitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected39 at risk
EG0031 events1 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Pharyngitis streptococcal
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Rhinitis
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0013 events3 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0051 events1 affected39 at risk
EG0061 events1 affected20 at risk
Urinary tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0031 events1 affected40 at risk
EG0042 events2 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Bone contusion
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Fall
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected20 at risk
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected20 at risk
Wound haematoma
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected39 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0021 events1 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected20 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Balance disorder
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Dizziness
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Headache
Nervous system disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0021 events1 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Dysuria
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Urinary hesitation
Renal and urinary disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Prostatitis
Reproductive system and breast disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected39 at risk
EG0060 events0 affected20 at risk
Blood blister
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0041 events1 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0042 events2 affected40 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected20 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0061 events1 affected20 at risk
Hypertension
Vascular disorders
MedDRA 18.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected44 at risk
EG0020 events0 affected39 at risk
EG0030 events0 affected40 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected39 at risk
EG0060 events0 affected20 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
22
BG00520
BG0067
BG007119
20
OG00444
OG00540
OG00639
30.0
OG00418.2
OG00527.5
OG00620.5
20
OG00444
OG00540
OG00639
0
OG0042.3
OG0050
OG0062.6
20
OG00444
OG00540
OG00639
5.0
OG0040
OG0050
OG0060
20
OG00444
OG00540
OG00639
0
OG0040
OG0052.5
OG0060
20
OG00444
OG00540
OG00638
20
ParticipantsOG00444
ParticipantsOG00540
ParticipantsOG00638
Title
Measurements
OG000441.15(344.99 to 564.11)
OG001397.52(279.60 to 565.17)
OG002401.85(313.66 to 514.82)
OG003504.78(332.66 to 765.95)
OG004513.53(414.42 to 636.36)
OG005365.19(275.62 to 483.87)
OG006510.88(416.00 to 627.40)
Day 29
ParticipantsOG00039
ParticipantsOG00138
ParticipantsOG00240
ParticipantsOG00320
ParticipantsOG00443
ParticipantsOG00540
ParticipantsOG00637
Title
Measurements
OG0001068.43(820.93 to 1390.57)
OG0011233.62(1010.37 to 1506.21)
OG0021004.49(839.19 to 1202.36)
OG003
Day 61
ParticipantsOG00039
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00443
ParticipantsOG00540
ParticipantsOG00636
Title
Measurements
OG0001168.56(915.50 to 1491.57)
OG0031081.64(750.47 to 1558.93)
OG004626.09(509.37 to 769.57)
OG005
Day 91
ParticipantsOG00039
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00442
ParticipantsOG00540
ParticipantsOG00637
Title
Measurements
OG0001078.35(839.60 to 1385.00)
OG003967.42(665.58 to 1406.14)
OG004579.56(463.07 to 725.34)
OG005
Day 181
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00440
ParticipantsOG00540
ParticipantsOG00636
Title
Measurements
OG000866.23(673.55 to 1114.04)
OG003763.51(514.29 to 1133.49)
OG004548.46(439.44 to 684.53)
OG005
Day 271
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00319
ParticipantsOG00439
ParticipantsOG00539
ParticipantsOG00633
Title
Measurements
OG000796.48(607.83 to 1043.70)
OG003579.19(329.21 to 1018.98)
OG004546.80(435.46 to 686.62)
OG005
Day 361
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00318
ParticipantsOG00434
ParticipantsOG00538
ParticipantsOG00635
Title
Measurements
OG000746.01(594.45 to 936.22)
OG003814.32(515.32 to 1286.80)
OG004573.22(458.58 to 716.51)
OG005
20
OG00444
OG00540
OG00638
20
ParticipantsOG00443
ParticipantsOG00540
ParticipantsOG00637
Title
Measurements
OG0002.42(1.96 to 2.99)
OG0013.26(2.29 to 4.63)
OG0022.50(2.11 to 2.97)
OG0032.41(1.82 to 3.20)
OG0040.92(0.86 to 0.97)
OG0052.63(2.17 to 3.18)
OG0062.64(2.12 to 3.30)
Day 61
ParticipantsOG00039
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00443
ParticipantsOG00540
ParticipantsOG00636
Title
Measurements
OG0002.65(2.21 to 3.17)
OG0032.14(1.60 to 2.87)
OG0041.24(1.08 to 1.42)
OG005
Day 91
ParticipantsOG00039
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00442
ParticipantsOG00540
ParticipantsOG00637
Title
Measurements
OG0002.44(2.05 to 2.92)
OG0031.92(1.43 to 2.56)
OG0041.14(1.04 to 1.25)
OG005
Day 181
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00440
ParticipantsOG00540
ParticipantsOG00636
Title
Measurements
OG0001.99(1.72 to 2.30)
OG0031.51(1.20 to 1.91)
OG0041.15(1.02 to 1.30)
OG005
Day 271
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00319
ParticipantsOG00439
ParticipantsOG00539
ParticipantsOG00633
Title
Measurements
OG0001.83(1.57 to 2.14)
OG0031.08(0.64 to 1.81)
OG0041.11(0.96 to 1.27)
OG005
Day 361
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00318
ParticipantsOG00434
ParticipantsOG00538
ParticipantsOG00635
Title
Measurements
OG0001.71(1.50 to 1.96)
OG0031.47(1.12 to 1.93)
OG0041.15(1.00 to 1.31)
OG005
20
OG00444
OG00540
OG00638
30.0
(11.89 to 54.28)
OG0040(0.00 to 8.22)
OG00535.0(20.63 to 51.68)
OG00640.5(24.75 to 57.90)
20
OG00444
OG00540
OG00638
20
ParticipantsOG00444
ParticipantsOG00540
ParticipantsOG00638
Title
Measurements
OG00099.63(74.22 to 133.73)
OG00195.29(62.83 to 144.54)
OG002101.51(75.45 to 136.58)
OG00367.93(30.62 to 150.71)
OG00492.34(76.64 to 111.25)
OG00570.18(55.27 to 89.11)
OG00682.13(64.16 to 105.14)
Day 29
ParticipantsOG00039
ParticipantsOG00138
ParticipantsOG00240
ParticipantsOG00320
ParticipantsOG00443
ParticipantsOG00540
ParticipantsOG00637
Title
Measurements
OG0001328.36(958.76 to 1840.45)
OG0011433.98(1053.24 to 1952.34)
OG0021047.68(810.79 to 1353.79)
OG003
Day 61
ParticipantsOG00039
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00442
ParticipantsOG00540
ParticipantsOG00637
Title
Measurements
OG0001050.29(774.32 to 1424.61)
OG003852.27(491.53 to 1477.76)
OG004104.00(80.54 to 134.30)
OG005
Day 91
ParticipantsOG00039
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00441
ParticipantsOG00540
ParticipantsOG00637
Title
Measurements
OG000817.05(603.67 to 1105.86)
OG003662.15(375.50 to 1167.62)
OG00495.29(77.73 to 116.82)
OG005
Day 181
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00440
ParticipantsOG00540
ParticipantsOG00636
Title
Measurements
OG000501.47(368.62 to 682.20)
OG003403.58(226.56 to 718.92)
OG00491.54(74.62 to 112.29)
OG005
Day 271
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00319
ParticipantsOG00439
ParticipantsOG00539
ParticipantsOG00633
Title
Measurements
OG000389.94(286.92 to 529.96)
OG003341.99(160.13 to 730.40)
OG00492.70(75.46 to 113.88)
OG005
Day 361
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00318
ParticipantsOG00434
ParticipantsOG00538
ParticipantsOG00635
Title
Measurements
OG000343.64(255.99 to 461.32)
OG003284.56(140.69 to 575.55)
OG00494.10(74.03 to 119.61)
OG005
20
OG00444
OG00540
OG00638
20
ParticipantsOG00443
ParticipantsOG00540
ParticipantsOG00637
Title
Measurements
OG00013.33(9.39 to 18.93)
OG00115.15(10.18 to 22.55)
OG00210.32(7.87 to 13.54)
OG00314.77(7.63 to 28.59)
OG0040.99(0.96 to 1.02)
OG00515.20(11.29 to 20.47)
OG00617.95(14.06 to 22.91)
Day 61
ParticipantsOG00039
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00442
ParticipantsOG00540
ParticipantsOG00637
Title
Measurements
OG00010.54(7.73 to 14.37)
OG00312.55(6.55 to 24.04)
OG0041.09(0.91 to 1.32)
OG005
Day 91
ParticipantsOG00039
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00441
ParticipantsOG00540
ParticipantsOG00637
Title
Measurements
OG0008.20(6.09 to 11.05)
OG0039.75(5.37 to 17.70)
OG0041.00(0.95 to 1.05)
OG005
Day 181
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00320
ParticipantsOG00440
ParticipantsOG00540
ParticipantsOG00636
Title
Measurements
OG0005.03(3.89 to 6.50)
OG0035.94(3.58 to 9.85)
OG0040.97(0.92 to 1.02)
OG005
Day 271
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00319
ParticipantsOG00439
ParticipantsOG00539
ParticipantsOG00633
Title
Measurements
OG0003.91(3.05 to 5.02)
OG0034.92(3.11 to 7.77)
OG0040.96(0.91 to 1.01)
OG005
Day 361
ParticipantsOG00036
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00318
ParticipantsOG00434
ParticipantsOG00538
ParticipantsOG00635
Title
Measurements
OG0003.45(2.74 to 4.33)
OG0034.22(2.61 to 6.80)
OG0040.96(0.91 to 1.02)
OG005
20
OG00444
OG00540
OG00638
85.0
(62.11 to 96.79)
OG0040(0.00 to 8.22)
OG00597.5(86.84 to 99.94)
OG00697.3(85.84 to 99.93)
37
NA
(NA to NA)
Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0031.01(0.63 to 1.61)
GMT: H3N2
Title
Measurements
OG000NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0011.53(1.03 to 2.28)
OG002NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0030.78(0.53 to 1.15)
GMT: B/Yamagata
Title
Measurements
OG000NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0011.38(0.81 to 2.36)
OG002NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0031.49(0.91 to 2.46)
GMFR: H1N1
Title
Measurements
OG000NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0011.13(0.68 to 1.87)
OG002NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0030.97(0.54 to 1.75)
GMFR: H3N2
Title
Measurements
OG000NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0011.53(0.86 to 2.72)
OG002NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0031.28(0.69 to 2.38)
GMFR: B/Yamagata
Title
Measurements
OG000NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.
OG0011.09(0.76 to 1.55)
OG002NA(NA to NA)Data is not available for this time point because the humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed.