A Dose-ranging Pediatric Study of an Adjuvanted Pandemic... | NCT04669691 | Trialant
NCT04669691
Sponsor
Seqirus
Status
Completed
Last Update Posted
Mar 13, 2024Actual
Enrollment
420Actual
Phase
Phase 2
Conditions
Influenza, Human
Interventions
H5N1 antigen combined with MF59 adjuvant
Countries
Estonia
Philippines
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
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT04669691
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V87_30
Secondary IDs
ID
Type
Description
Link
2016-001898-32
EudraCT Number
Brief Title
A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine
Official Title
A Phase 2, Randomized, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Several Doses of Antigen and MF59 Adjuvant Content in a Monovalent H5N1 Pandemic Influenza Vaccine in Healthy Pediatric Subjects 6 Months to < 9 Years of Age
Acronym
Not provided
Organization
SeqirusINDUSTRY
Status Module
Record Verification Date
Feb 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 19, 2020Actual
Primary Completion Date
Apr 15, 2022Actual
Completion Date
Apr 15, 2022Actual
First Submitted Date
Nov 30, 2016
First Submission Date that Met QC Criteria
Dec 9, 2020
First Posted Date
Dec 17, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Apr 5, 2023
Results First Submitted that Met QC Criteria
Apr 5, 2023
Results First Posted Date
Jan 16, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 21, 2024
Last Update Posted Date
Mar 13, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SeqirusINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a pediatric dose-ranging study to evaluate the safety and immunogenicity of vaccination with different MF59-adjuvanted H5N1 vaccine formulations.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza, Human
Keywords
Pandemic
Influenza
Vaccine
MF59
Adjuvant
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
420Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Lowest dose, less adjuvant aH5N1 vaccine
Experimental
Two consecutive intramuscular (IM) administrations (Day 1 and Day 22)
Biological: H5N1 antigen combined with MF59 adjuvant
Low dose, less adjuvant aH5N1 vaccine
Experimental
Two consecutive IM administrations (Day 1 and Day 22)
Biological: H5N1 antigen combined with MF59 adjuvant
Mid dose, less adjuvant aH5N1 vaccine
Experimental
Two consecutive IM administrations (Day 1 and Day 22)
Biological: H5N1 antigen combined with MF59 adjuvant
Lowest dose, adjuvanted aH5N1 vaccine
Experimental
Two consecutive IM administrations (Day 1 and Day 22)
Biological: H5N1 antigen combined with MF59 adjuvant
Low dose, adjuvanted aH5N1 vaccine
Experimental
Two consecutive IM administrations (Day 1 and Day 22)
Biological: H5N1 antigen combined with MF59 adjuvant
Mid dose, adjuvanted aH5N1 vaccine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
H5N1 antigen combined with MF59 adjuvant
Biological
Eligible subjects will be stratified by age at the time of enrollment into one of 2 age cohorts and within each age cohort will be randomly assigned (equally) to 1 of 6 study vaccine groups. Subjects in each study vaccine group will be scheduled to receive 2 injections of aH5N1 vaccine 3 weeks apart
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Percentages of subjects with solicited local and systemic AEs that occurred within 7 days following each vaccination, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Day 1 through Day 7 and Day 22 through Day 28
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Percentages of subjects with any unsolicited AEs reported within 21 days after each vaccination within each vaccine group, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Day 1 through Day 43
Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal
Percentages of subjects reporting SAEs, NOCDs, AESIs, and AEs leading to vaccine and/or study withdrawal, as collected from Day 1 through Day 387, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Day 1 through Day 387
Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain
GMTs on Day 1 (prior to the first vaccination), Day 22 (3 weeks after the first vaccination), and Day 43 (3 weeks after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Secondary Outcomes
Measure
Description
Time Frame
Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMTs on Day 1 (prior to the first vaccination) and Day 202 (6 months after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Day 1 (baseline) and Day 202
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy male and female subjects of 6 months through <9 years of age on the day of informed consent/assent.
Documented consent provided by the subject's parent(s)/LAR(s) have voluntarily given written informed consent/assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Subject's parent(s)/LAR(s) able to comprehend and comply with all study procedures, and available for all clinic visits and telephone contacts scheduled in the study.
Subjects must provide a baseline blood sample within 10 days prior to the Day 1 vaccination.
Exclusion Criteria:
Each subject must not have:
Progressive, unstable or uncontrolled clinical conditions.
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws, ie,
Subjects who have had a fever (body temperature measurement ≥ 38°C) within three days prior to vaccination. The subject may return for vaccination after they have been free of fever for three days.
History of epilepsy or convulsions (excluding febrile convulsions).
A subject who has any medical condition meeting the definition of AESI defined for the purposes of this trial (see appendix A).
Subjects who have received antipyretic medication within the past 24 hours prior to vaccination. The subject may return for vaccination after a period of 24 hours has passed since the administration of an antipyretic.
Abnormal function of the immune system resulting from:
Clinical conditions.
Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent/assent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted.
Administration of antineoplastic and immunomodulating agents or radiotherapy from within 90 days prior to informed consent/assent.
Suspicion of pandemic influenza illness within past six months or have ever received previous pandemic H5N1 flu vaccination.
Received immunoglobulins or any blood products within 180 days prior to informed consent/assent.
Received an investigational or non-registered medicinal within 30 days prior to informed consent/assent.
Children of study site staff (this includes research or clinic staff) or children who are otherwise related to study site staff or have household members who are study site staff. Study site staff are employees with direct or indirect contact with study subjects and/or have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, medical assistants, document scanners, etc. study personnel as an immediate family or household member.
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine prior to day 43. Following day 43 other vaccines may be administered, including seasonal flu.
Vesikari T, Karvonen A, Tilman S, Borkowski A, Montomoli E, Banzhoff A, Clemens R. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics. 2010 Oct;126(4):e762-70. doi: 10.1542/peds.2009-2628. Epub 2010 Sep 6.
Vesikari T, Forsten A, Borkowski A, Gaitatzis N, Banzhoff A, Clemens R. Homologous and heterologous antibody responses to a one-year booster dose of an MF59((R)) adjuvanted A/H5N1 pre-pandemic influenza vaccine in pediatric subjects. Hum Vaccin Immunother. 2012 Jul;8(7):921-8. doi: 10.4161/hv.20248. Epub 2012 Jul 1.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
SEQIRUS supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release.
Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry [EU CTR])
Types
Study Protocol
Statistical Analysis Plan (SAP)
Time Frame
SEQIRUS discloses results from clinical studies within 12 months of last patient last visit (LPLV) unless otherwise mandated by local laws or regulations.
Access Criteria
SEQIRUS will consider requests from qualified scientific and medical researchers to disclose protocols, anonymized subject-level data and study-level data when there is medical, scientific and/or public health interest to ensure the safe use of a Seqirus product licensed on or after 1 January 2014 in the United States (US) and/or the European Union (EU). This applies to Seqirus-sponsored interventional studies initiated after 27 September 2007 and ongoing as of 26 December 2007, that have been included as part of a US or EU submission package which received approval in US and EU on or after 1 January 2014 and have been accepted for publication
In total, 420 subjects were enrolled in the study.
Recruitment Details
Subjects were enrolled from 2 centers in Estonia and 5 centers in the Philippines.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
FG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
FG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
FG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
FG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
FG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00069 subjects
FG00172 subjects
FG00270 subjects
FG00370 subjects
FG00469 subjects
FG00570 subjects
COMPLETED
FG00069 subjects
FG00171 subjects
FG00270 subjects
FG00370 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
BG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
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, Categorical
Count of Participants
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
Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Percentages of subjects with solicited local and systemic AEs that occurred within 7 days following each vaccination, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Solicited Safety Set, defined as all subjects in the All Exposed Set with any solicited AE data collected, including temperature measurements or use of analgesics/antipyretics.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Count of Participants
Participants
Day 1 through Day 7 and Day 22 through Day 28
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
Adverse Events Module
Frequency Threshold
5
Time Frame
SAEs and nonserious unsolicited AEs: Day 1 through Day 387; solicited AEs: Day 1 through Day 7 and Day 22 through Day 28
Description
SAEs, nonserious unsolicited AEs, and solicited AEs are reported in this Adverse Events section
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
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
Two consecutive IM administrations (Day 1 and Day 22)
Biological: H5N1 antigen combined with MF59 adjuvant
Low dose, adjuvanted aH5N1 vaccine
Low dose, less adjuvant aH5N1 vaccine
Lowest dose, adjuvanted aH5N1 vaccine
Lowest dose, less adjuvant aH5N1 vaccine
Mid dose, adjuvanted aH5N1 vaccine
Mid dose, less adjuvant aH5N1 vaccine
aH5N1
Day 1 (baseline), Day 22, and Day 43
Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMRs calculated as follows: Day 22/Day 1 and Day 43/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Day 1 (baseline), Day 22, and Day 43
Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)
Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 22 and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Day 1 (baseline), Day 22, and Day 43
Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40
Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1, Day 22, and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Day 1 (baseline), Day 22, and Day 43
Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMRs calculated as follows: Day 202/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Day 1 (baseline) and Day 202
Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)
Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 202 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Day 1 (baseline) and Day 202
Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40
Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1 and Day 202 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
Day 1 (baseline) and Day 202
Tartu
Tartu
50106
Estonia
60805 - De La Salle Medical and Health Sciences Institute
Dasmariñas
Manila
4114
Philippines
60804 - University of Perpetual Help Dalta Medical Center
Las Piñas
Manila
1742
Philippines
60802- Philippine General Hospital
Manila
National Capital Region
1000
Philippines
60803- Philippine General Hospital - Pediatrics
Manila
National Capital Region
1000
Philippines
60801- Philippine General Hospital - Pediatrics
Manila
1000
Philippines
69 subjects
FG00570 subjects
0 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
BG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
BG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
BG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
BG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
BG006
Total
Total of all reporting groups
69
BG00172
BG00270
BG00370
BG00469
BG00570
BG006420
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG00069
BG00172
BG00270
BG00370
BG00469
BG00570
BG006420
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Age, Continuous
Mean
Standard Deviation
months
Title
Denominators
Categories
Title
Measurements
BG00048.2± 28.80
BG00150.9± 31.61
BG00247.1± 30.90
BG00348.8± 31.81
BG00449.9± 30.79
BG00550.6± 31.77
BG00649.3± 30.82
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
6 months to <36 months
Title
Measurements
BG00035
BG00135
BG00235
BG00335
BG00436
BG00534
BG006210
3 years to <9 years
Title
Measurements
BG00034
BG00137
BG00235
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00031
BG00126
BG00233
BG00331
BG00431
BG00540
BG006192
Male
BG00038
BG00146
BG00237
BG00339
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Not Hispanic or Latino
BG00069
BG00172
BG00270
BG00370
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Asian
BG00052
BG00156
BG00253
BG00353
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG00017
BG00116
BG00217
BG00317
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
Philippines
Title
Measurements
BG00052
BG00156
BG00253
BG00353
BG00452
BG00554
BG006320
Estonia
Title
Measurements
BG00017
BG00116
BG00217
BG003
Received an influenza vaccination in the past 2 years
Count of Participants
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG0001
BG0010
BG0023
BG0033
BG0043
BG0052
BG00612
No
Title
Measurements
BG00068
BG00172
BG00267
BG003
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00069
OG00172
OG00270
OG00370
OG00469
OG00570
Title
Denominators
Categories
Solicited AEs (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG00032
OG00133
OG00232
OG003
Solicited Local AEs (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
Solicited Systemic AEs (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG003
Analgesic/antipyretic use (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG003
Solicited AEs (6 months to <36 years age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG003
Solicited Local AEs (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG003
Solicited Systemic AEs (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG003
Analgesic/antipyretic use (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG003
Solicited AEs (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
Solicited Local AEs (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG003
Solicited Systemic AEs (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG003
Analgesic/antipyretic use (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG003
Primary
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Percentages of subjects with any unsolicited AEs reported within 21 days after each vaccination within each vaccine group, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Unsolicited Safety Set, defined as all subjects in the All Exposed Set with unsolicited AE data.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Count of Participants
Participants
Day 1 through Day 43
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00069
OG00172
OG00270
OG003
Title
Denominators
Categories
Unsolicited AEs, Any (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG003
Primary
Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal
Percentages of subjects reporting SAEs, NOCDs, AESIs, and AEs leading to vaccine and/or study withdrawal, as collected from Day 1 through Day 387, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Unsolicited Safety Set, defined as all subjects in the All Exposed Set with unsolicited AE data.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Count of Participants
Participants
Day 1 through Day 387
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00069
OG00172
OG00270
OG003
Title
Denominators
Categories
SAE (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG003
Primary
Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain
GMTs on Day 1 (prior to the first vaccination), Day 22 (3 weeks after the first vaccination), and Day 43 (3 weeks after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
Per Protocol Set (PPS) Immunogenicity, defined as all subjects in the Full Analysis Set (FAS) Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 (baseline), Day 22, and Day 43
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00067
OG00171
OG00267
OG003
Title
Denominators
Categories
HI GMT Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG003
Primary
Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMRs calculated as follows: Day 22/Day 1 and Day 43/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 1 (baseline), Day 22, and Day 43
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00067
OG00171
OG00267
OG003
Title
Denominators
Categories
HI GMR Day 22/Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG003
Primary
Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)
Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 22 and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Number
95% Confidence Interval
percentage of participants
Day 1 (baseline), Day 22, and Day 43
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00067
OG00171
OG00267
OG003
Title
Denominators
Categories
HI seroconversion at Day 22 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG003
Primary
Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40
Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1, Day 22, and Day 43 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
No statistical analyses have been specified for this primary endpoint. The statistical analysis was descriptive in nature without any prespecified inferential analyses.
PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Number
95% Confidence Interval
percentage of participants
Day 1 (baseline), Day 22, and Day 43
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00067
OG00171
OG00267
OG003
Title
Denominators
Categories
HI titer ≥1:40 at Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG003
Secondary
Secondary Immunogenicity Endpoint 1a: GMTs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMTs on Day 1 (prior to the first vaccination) and Day 202 (6 months after the second vaccination) as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 1 (baseline) and Day 202
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00067
OG00171
OG00267
OG003
Title
Denominators
Categories
HI GMT Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG003
Secondary
Secondary Immunogenicity Endpoint 1b: GMRs, as Measured by HI and MN Assays Against the Homologous H5N1 Strain
GMRs calculated as follows: Day 202/Day 1 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 1 (baseline) and Day 202
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00067
OG00171
OG00267
OG003
Title
Denominators
Categories
HI GMR Day 202/Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG003
Secondary
Secondary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)
Percentage of subjects achieving seroconversion (non-detectable to ≥1:40, or 4-fold increase from a detectable Day 1 titer) on Day 202 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Number
95% Confidence Interval
percentage of participants
Day 1 (baseline) and Day 202
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00067
OG00171
OG00267
OG003
Title
Denominators
Categories
HI seroconversion at Day 202 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG003
Secondary
Secondary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40
Percentage of subjects achieving seroconversion with a titer ≥1:40 on Day 1 and Day 202 as determined by HI and MN assays against the homologous H5N1 pandemic influenza strain, by total population and by age cohort.
PPS Immunogenicity, defined as all subjects in the FAS Immunogenicity who: correctly received the vaccine; provided at least the baseline and one postbaseline blood sample, with evaluable immunogenicity data; had no protocol deviations leading to exclusion as defined prior to unblinding/analysis.
Results are presented for the overall study population and for the 6 months to <36 months and 3 years to <9 years age cohorts.
Posted
Number
95% Confidence Interval
percentage of participants
Day 1 (baseline) and Day 202
ID
Title
Description
OG000
Lowest Dose, Less Adjuvant aH5N1 Vaccine
2 doses of lowest dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
OG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
OG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
Units
Counts
Participants
OG00067
OG00171
OG00267
OG003
Title
Denominators
Categories
HI titer ≥1:40 at Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG003
0
69
0
69
37
69
EG001
Low Dose, Less Adjuvant aH5N1 Vaccine
2 doses of low dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
1
72
1
72
34
72
EG002
Mid Dose, Less Adjuvant aH5N1 Vaccine
2 doses of mid dose, less adjuvant aH5N1 by IM administration (Day 1 and Day 22)
0
70
3
70
40
70
EG003
Lowest Dose, Adjuvanted aH5N1 Vaccine
2 doses of lowest dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
0
70
0
70
39
70
EG004
Low Dose, Adjuvanted aH5N1 Vaccine
2 doses of low dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
0
69
1
69
37
69
EG005
Mid Dose, Adjuvanted aH5N1 Vaccine
2 doses of mid dose, adjuvanted aH5N1 by IM administration (Day 1 and Day 22)
0
70
3
70
33
70
EG0000 affected69 at risk
EG0011 affected72 at risk
EG0020 affected70 at risk
EG0030 affected70 at risk
EG0040 affected69 at risk
EG0050 affected70 at risk
Pneumonia
Infections and infestations
MedDRA version 25.0
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected72 at risk
EG0020 affected70 at risk
EG0030 affected70 at risk
EG0041 affected69 at risk
EG0050 affected70 at risk
Septic shock
Infections and infestations
MedDRA version 25.0
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected72 at risk
EG0020 affected70 at risk
EG0030 affected70 at risk
EG0040 affected69 at risk
EG0050 affected70 at risk
Animal bite
Injury, poisoning and procedural complications
MedDRA version 25.0
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected72 at risk
EG0022 affected70 at risk
EG0030 affected70 at risk
EG0040 affected69 at risk
EG0052 affected70 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA version 25.0
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected72 at risk
EG0021 affected70 at risk
EG0030 affected70 at risk
EG0040 affected69 at risk
EG0050 affected70 at risk
Brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected72 at risk
EG0020 affected70 at risk
EG0030 affected70 at risk
EG0040 affected69 at risk
EG0050 affected70 at risk
Febrile convulsion
Nervous system disorders
MedDRA version 25.0
Systematic Assessment
EG0000 affected69 at risk
EG0010 affected72 at risk
EG0020 affected70 at risk
EG0030 affected70 at risk
EG0041 affected69 at risk
EG0051 affected70 at risk
EG0001 affected69 at risk
EG0010 affected72 at risk
EG0022 affected70 at risk
EG0034 affected70 at risk
EG0040 affected69 at risk
EG0054 affected70 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA version 25.0
Systematic Assessment
EG0006 affected69 at risk
EG0014 affected72 at risk
EG00212 affected70 at risk
EG0031 affected70 at risk
EG0045 affected69 at risk
EG0055 affected70 at risk
Injection site erythema
General disorders
Solicited AE
Systematic Assessment
EG0004 affected69 at risk
EG0015 affected72 at risk
EG0027 affected70 at risk
EG0035 affected70 at risk
EG0045 affected69 at risk
EG0054 affected70 at risk
Injection site induration
General disorders
Solicited AE
Systematic Assessment
EG0003 affected69 at risk
EG0013 affected72 at risk
EG0024 affected70 at risk
EG0035 affected70 at risk
EG0045 affected69 at risk
EG0054 affected70 at risk
Injection site tenderness or pain
General disorders
Solicited AE
Systematic Assessment
EG00021 affected69 at risk
EG00112 affected72 at risk
EG00217 affected70 at risk
EG00317 affected70 at risk
EG00419 affected69 at risk
EG00517 affected70 at risk
Change of eating habits
Metabolism and nutrition disorders
Solicited AE
Systematic Assessment
EG0007 affected69 at risk
EG0018 affected72 at risk
EG0023 affected70 at risk
EG0034 affected70 at risk
EG0046 affected69 at risk
EG0054 affected70 at risk
Diarrhea
Gastrointestinal disorders
Solicited AE
Systematic Assessment
EG00010 affected69 at risk
EG00112 affected72 at risk
EG00211 affected70 at risk
EG00310 affected70 at risk
EG0046 affected69 at risk
EG0056 affected70 at risk
Fatigue
General disorders
Solicited AE
Systematic Assessment
EG0001 affected69 at risk
EG0012 affected72 at risk
EG0024 affected70 at risk
EG0034 affected70 at risk
EG0046 affected69 at risk
EG0053 affected70 at risk
Fever (≥38.0°C)
General disorders
Solicited AE
Systematic Assessment
EG0008 affected69 at risk
EG0019 affected72 at risk
EG0027 affected70 at risk
EG0037 affected70 at risk
EG0042 affected69 at risk
EG0056 affected70 at risk
Headache
Nervous system disorders
Solicited AE
Systematic Assessment
EG0003 affected69 at risk
EG0012 affected72 at risk
EG0022 affected70 at risk
EG0033 affected70 at risk
EG0043 affected69 at risk
EG0054 affected70 at risk
Irritability
Psychiatric disorders
Solicited AE
Systematic Assessment
EG0008 affected69 at risk
EG0019 affected72 at risk
EG0024 affected70 at risk
EG0036 affected70 at risk
EG00410 affected69 at risk
EG0054 affected70 at risk
Sleepiness
Nervous system disorders
Solicited AE
Systematic Assessment
EG0009 affected69 at risk
EG0017 affected72 at risk
EG0025 affected70 at risk
EG0036 affected70 at risk
EG0048 affected69 at risk
EG0053 affected70 at risk
Vomiting
Gastrointestinal disorders
Solicited AE
Systematic Assessment
EG0003 affected69 at risk
EG0015 affected72 at risk
EG0025 affected70 at risk
EG0036 affected70 at risk
EG0044 affected69 at risk
EG0051 affected70 at risk
Other solicited AE
General disorders
Solicited AE
Systematic Assessment
Analgesic/antipyretic use for prevention of pain/fever
EG0006 affected69 at risk
EG0016 affected72 at risk
EG0025 affected70 at risk
EG0033 affected70 at risk
EG0044 affected69 at risk
EG0055 affected70 at risk
Other solicited AE
General disorders
Solicited AE
Systematic Assessment
Analgesic/antipyretic use for treatment of pain/fever
EG0007 affected69 at risk
EG0017 affected72 at risk
EG0025 affected70 at risk
EG0033 affected70 at risk
EG0044 affected69 at risk
EG0057 affected70 at risk
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
0
BG0050
BG0060
0
BG0050
BG0060
35
BG00433
BG00536
BG006210
38
BG00530
BG006228
69
BG00570
BG006420
0
BG0050
BG0060
52
BG00553
BG006319
0
BG0050
BG0060
0
BG0051
BG0061
17
BG00516
BG006100
0
BG0050
BG0060
0
BG0050
BG0060
17
BG00417
BG00516
BG006100
67
BG00466
BG00568
BG006408
34
OG00437
OG00531
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG00019
OG00116
OG00216
OG00321
OG00419
OG00517
70
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG00021
OG00124
OG00220
OG00324
OG00429
OG00518
70
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG0009
OG0017
OG0026
OG0035
OG0045
OG0059
35
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG00015
OG00120
OG00218
OG00320
OG00421
OG00515
35
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0007
OG00110
OG0026
OG00311
OG0048
OG0054
35
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG00014
OG00115
OG00216
OG00316
OG00418
OG00511
35
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0005
OG0014
OG0024
OG0033
OG0043
OG0056
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG00017
OG00113
OG00214
OG00314
OG00416
OG00516
35
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG00012
OG0016
OG00210
OG00310
OG00411
OG00513
35
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0007
OG0019
OG0024
OG0038
OG00411
OG0057
35
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0004
OG0013
OG0022
OG0032
OG0042
OG0053
70
OG00469
OG00570
70
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG00018
OG00115
OG00220
OG00310
OG00415
OG00512
Unsolicited AEs, Mild (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG00018
OG00114
OG00220
OG003
Unsolicited AEs, Moderate (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG0000
OG0011
OG0020
OG003
Unsolicited AEs, Severe (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unsolicited AEs, Related (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG0002
OG0012
OG0022
OG003
Unsolicited AEs, Any (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG00012
OG00111
OG00213
OG003
Unsolicited AEs, Mild (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG00012
OG00110
OG00213
OG003
Unsolicited AEs, Moderate (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0000
OG0011
OG0020
OG003
Unsolicited AEs, Severe (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unsolicited AEs, Related (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0001
OG0012
OG0022
OG003
Unsolicited AEs, Any (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0006
OG0014
OG0027
OG003
Unsolicited AEs, Mild (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0006
OG0014
OG0027
OG003
Unsolicited AEs, Moderate (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unsolicited AEs, Severe (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000
OG0010
OG0020
OG003
Unsolicited AEs, Related (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0001
OG0010
OG0020
OG003
70
OG00469
OG00570
70
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG0000
OG0011
OG0023
OG0030
OG0041
OG0053
Related SAE (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG0000
OG0010
OG0020
OG003
NOCD (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG0000
OG0011
OG0020
OG003
AESI (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG0000
OG0010
OG0020
OG003
AE leading to withdrawal (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG0000
OG0010
OG0020
OG003
Death (overall study population)
ParticipantsOG00069
ParticipantsOG00172
ParticipantsOG00270
ParticipantsOG00370
ParticipantsOG00469
ParticipantsOG00570
Title
Measurements
OG0000
OG0011
OG0020
OG003
SAE (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0000
OG0011
OG0021
OG003
Related SAE (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0000
OG0010
OG0020
OG003
NOCD (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0000
OG0010
OG0020
OG003
AESI (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0000
OG0010
OG0020
OG003
AE leading to withdrawal (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0000
OG0010
OG0020
OG003
Death (6 months to <36 months age cohort)
ParticipantsOG00035
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00534
Title
Measurements
OG0000
OG0011
OG0020
OG003
SAE (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000
OG0010
OG0022
OG003
Related SAE (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000
OG0010
OG0020
OG003
NOCD (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000
OG0011
OG0020
OG003
AESI (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000
OG0010
OG0020
OG003
AE leading to withdrawal (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000
OG0010
OG0020
OG003
Death (3 years to <9 years age cohort)
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00235
ParticipantsOG00335
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000
OG0010
OG0020
OG003
66
OG00469
OG00567
66
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0005.05(4.8 to 5.3)
OG0015.00(4.8 to 5.2)
OG0025.21(5.0 to 5.4)
OG0035.05(4.8 to 5.3)
OG0045.00(4.8 to 5.2)
OG0055.24(5.0 to 5.5)
HI GMT Day 22 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0005.61(4.9 to 6.4)
OG0016.21(5.5 to 7.0)
OG0025.98(5.3 to 6.8)
OG003
HI GMT Day 43 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG00081.10(58.3 to 112.8)
OG00168.06(49.4 to 93.8)
OG00286.70(62.3 to 120.7)
OG003
HI GMT Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0005.10(4.9 to 5.3)
OG0015.00(4.8 to 5.2)
OG0025.42(5.2 to 5.7)
OG003
HI GMT Day 22 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0005.59(4.7 to 6.6)
OG0016.14(5.2 to 7.3)
OG0025.51(4.6 to 6.6)
OG003
HI GMT Day 43 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG00093.22(56.5 to 153.7)
OG00198.37(59.6 to 162.4)
OG002102.28(61.5 to 170.1)
OG003
HI GMT Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0005.00(4.6 to 5.4)
OG0015.00(4.7 to 5.4)
OG0025.00(4.6 to 5.4)
OG003
HI GMT Day 22 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0005.61(4.6 to 6.8)
OG0016.32(5.3 to 7.6)
OG0026.29(5.2 to 7.6)
OG003
HI GMT Day 43 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG00070.21(45.5 to 108.4)
OG00148.35(32.1 to 72.9)
OG00269.40(44.9 to 107.2)
OG003
MN GMT Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0005.19(4.9 to 5.5)
OG0015.27(5.0 to 5.6)
OG0025.38(5.1 to 5.7)
OG003
MN GMT Day 22 (overall study population)
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00267
ParticipantsOG00364
ParticipantsOG00466
ParticipantsOG00567
Title
Measurements
OG00031.42(24.7 to 40.0)
OG00134.83(27.5 to 44.2)
OG00240.61(31.9 to 51.7)
OG003
MN GMT Day 43 (overall study population)
ParticipantsOG00067
ParticipantsOG00170
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG000531.04(424.7 to 664.1)
OG001667.86(536.7 to 831.1)
OG002610.37(488.0 to 763.4)
OG003
MN GMT Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0005.00(4.7 to 5.3)
OG0015.00(4.7 to 5.3)
OG0025.26(4.9 to 5.6)
OG003
MN GMT Day 22 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00331
ParticipantsOG00434
ParticipantsOG00531
Title
Measurements
OG00029.27(21.0 to 40.8)
OG00133.14(23.8 to 46.2)
OG00224.93(17.9 to 34.7)
OG003
MN GMT Day 43 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG000618.77(448.2 to 854.3)
OG001910.32(659.3 to 1256.9)
OG002717.83(520.0 to 991.0)
OG003
MN GMT Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0005.38(4.9 to 5.9)
OG0015.54(5.1 to 6.0)
OG0025.49(5.0 to 6.0)
OG003
MN GMT Day 22 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00432
ParticipantsOG00536
Title
Measurements
OG00033.70(24.0 to 47.4)
OG00136.69(26.3 to 51.1)
OG00266.97(47.6 to 94.2)
OG003
MN GMT Day 43 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG000458.11(334.2 to 627.9)
OG001495.77(366.4 to 670.9)
OG002518.46(378.2 to 710.8)
OG003
66
OG00469
OG00567
66
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0001.11(1.0 to 1.3)
OG0011.24(1.1 to 1.4)
OG0021.15(1.0 to 1.3)
OG0031.22(1.1 to 1.4)
OG0041.29(1.1 to 1.5)
OG0051.11(1.0 to 1.3)
HI GMR Day 43/Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG00016.14(11.5 to 22.6)
OG00113.77(9.9 to 19.1)
OG00216.38(11.7 to 23.0)
OG003
HI GMR Day 22/Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0001.10(0.9 to 1.3)
OG0011.21(1.0 to 1.4)
OG0021.05(0.9 to 1.3)
OG003
HI GMR Day 43/Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG00018.27(11.1 to 30.1)
OG00119.62(11.9 to 32.4)
OG00219.02(11.5 to 31.4)
OG003
HI GMR Day 22/Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0001.12(0.9 to 1.4)
OG0011.26(1.0 to 1.5)
OG0021.26(1.0 to 1.5)
OG003
HI GMR Day 43/Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG00014.27(9.0 to 22.6)
OG0019.83(6.4 to 15.2)
OG00214.10(8.9 to 22.3)
OG003
MN GMR Day 22/Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00267
ParticipantsOG00364
ParticipantsOG00466
ParticipantsOG00567
Title
Measurements
OG0006.02(4.7 to 7.7)
OG0016.62(5.2 to 8.4)
OG0027.66(6.0 to 9.8)
OG003
MN GMR Day 43/Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00170
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG000102.26(81.4 to 128.5)
OG001126.71(101.4 to 158.4)
OG002113.98(90.7 to 143.2)
OG003
MN GMR Day 22/Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00331
ParticipantsOG00434
ParticipantsOG00531
Title
Measurements
OG0005.76(4.1 to 8.0)
OG0016.52(4.7 to 9.1)
OG0024.80(3.4 to 6.7)
OG003
MN GMR Day 43/Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG000122.81(88.8 to 169.9)
OG001180.68(130.6 to 250.0)
OG002137.36(99.3 to 190.0)
OG003
MN GMR Day 22/Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00432
ParticipantsOG00536
Title
Measurements
OG0006.29(4.5 to 8.9)
OG0016.73(4.8 to 9.4)
OG00212.37(8.8 to 17.4)
OG003
MN GMR Day 43/Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG00085.22(61.6 to 118.0)
OG00189.57(65.6 to 122.3)
OG00294.64(68.4 to 131.0)
OG003
66
OG00469
OG00567
66
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0000.0(0.00 to 5.36)
OG0014.2(0.88 to 11.86)
OG0023.0(0.36 to 10.37)
OG0034.5(0.95 to 12.71)
OG0041.4(0.04 to 7.81)
OG0053.0(0.36 to 10.37)
HI seroconversion at Day 43 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG00082.1(70.80 to 90.39)
OG00174.6(62.92 to 84.23)
OG00277.6(65.78 to 86.89)
OG003
HI seroconversion at Day 22 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0000.0(0.00 to 10.28)
OG0012.9(0.07 to 15.33)
OG0020.0(0.00 to 10.28)
OG003
HI seroconversion at Day 43 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG00079.4(62.10 to 91.30)
OG00182.4(65.47 to 93.24)
OG00279.4(62.10 to 91.30)
OG003
HI seroconversion at Day 22 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000.0(0.00 to 10.58)
OG0015.4(0.66 to 18.19)
OG0026.1(0.74 to 20.23)
OG003
HI seroconversion at Day 43 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG00084.8(68.10 to 94.89)
OG00167.6(50.21 to 81.99)
OG00275.8(57.74 to 88.91)
OG003
MN seroconversion at Day 22 (overall study population)
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00267
ParticipantsOG00364
ParticipantsOG00466
ParticipantsOG00567
Title
Measurements
OG00044.8(32.60 to 57.42)
OG00156.5(44.04 to 68.42)
OG00258.2(45.52 to 70.15)
OG003
MN seroconversion at Day 43 (overall study population)
ParticipantsOG00067
ParticipantsOG00170
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG000100.0(94.64 to 100.00)
OG001100.0(94.87 to 100.00)
OG002100.0(94.64 to 100.00)
OG003
MN seroconversion at Day 22 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00331
ParticipantsOG00434
ParticipantsOG00531
Title
Measurements
OG00035.3(19.75 to 53.51)
OG00155.9(37.89 to 72.81)
OG00235.3(19.75 to 53.51)
OG003
MN seroconversion at Day 43 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG000100.0(89.72 to 100.00)
OG001100.0(89.72 to 100.00)
OG002100.0(89.72 to 100.00)
OG003
MN seroconversion at Day 22 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00432
ParticipantsOG00536
Title
Measurements
OG00054.5(36.35 to 71.89)
OG00157.1(39.35 to 73.68)
OG00281.8(64.54 to 93.02)
OG003
MN seroconversion at Day 43 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG000100.0(89.42 to 100.00)
OG001100.0(90.26 to 100.00)
OG002100.0(89.42 to 100.00)
OG003
66
OG00469
OG00567
66
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0000.0(0.00 to 5.36)
OG0010.0(0.00 to 5.06)
OG0020.0(0.00 to 5.36)
OG0030.0(0.00 to 5.44)
OG0040.0(0.00 to 5.21)
OG0051.5(0.04 to 8.04)
HI titer ≥1:40 at Day 22 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0000.0(0.00 to 5.36)
OG0014.2(0.88 to 11.86)
OG0023.0(0.36 to 10.37)
OG003
HI titer ≥1:40 at Day 43 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG00082.1(70.80 to 90.39)
OG00174.6(62.92 to 84.23)
OG00277.6(65.78 to 86.89)
OG003
HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0000.0(0.00 to 10.28)
OG0010.0(0.00 to 10.28)
OG0020.0(0.00 to 10.28)
OG003
HI titer ≥1:40 at Day 22 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0000.0(0.00 to 10.28)
OG0012.9(0.07 to 15.33)
OG0020.0(0.00 to 10.28)
OG003
HI titer ≥1:40 at Day 43 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG00079.4(62.10 to 91.30)
OG00182.4(65.47 to 93.24)
OG00279.4(62.10 to 91.30)
OG003
HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000.0(0.00 to 10.58)
OG0010.0(0.00 to 9.49)
OG0020.0(0.00 to 10.58)
OG003
HI titer ≥1:40 at Day 22 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000.0(0.00 to 10.58)
OG0015.4(0.66 to 18.19)
OG0026.1(0.74 to 20.23)
OG003
HI titer ≥1:40 at Day 43 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG00084.8(68.10 to 94.89)
OG00167.6(50.21 to 81.99)
OG00275.8(57.74 to 88.91)
OG003
MN titer ≥1:40 at Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0000.0(0.00 to 5.36)
OG0010.0(0.00 to 5.06)
OG0020.0(0.00 to 5.36)
OG003
MN titer ≥1:40 at Day 22 (overall study population)
ParticipantsOG00067
ParticipantsOG00169
ParticipantsOG00267
ParticipantsOG00364
ParticipantsOG00466
ParticipantsOG00567
Title
Measurements
OG00044.8(32.60 to 57.42)
OG00156.5(44.04 to 68.42)
OG00258.2(45.52 to 70.15)
OG003
MN titer ≥1:40 at Day 43 (overall study population)
ParticipantsOG00067
ParticipantsOG00170
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG000100.0(94.64 to 100.00)
OG001100.0(94.87 to 100.00)
OG002100.0(94.64 to 100.00)
OG003
MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0000.0(0.00 to 10.28)
OG0010.0(0.00 to 10.28)
OG0020.0(0.00 to 10.28)
OG003
MN titer ≥1:40 at Day 22 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00331
ParticipantsOG00434
ParticipantsOG00531
Title
Measurements
OG00035.3(19.75 to 53.51)
OG00155.9(37.89 to 72.81)
OG00235.3(19.75 to 53.51)
OG003
MN titer ≥1:40 at Day 43 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG000100.0(89.72 to 100.00)
OG001100.0(89.72 to 100.00)
OG002100.0(89.72 to 100.00)
OG003
MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000.0(0.00 to 10.58)
OG0010.0(0.00 to 9.49)
OG0020.0(0.00 to 10.58)
OG003
MN titer ≥1:40 at Day 22 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00432
ParticipantsOG00536
Title
Measurements
OG00054.5(36.35 to 71.89)
OG00157.1(39.35 to 73.68)
OG00281.8(64.54 to 93.02)
OG003
MN titer ≥1:40 at Day 43 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG000100.0(89.42 to 100.00)
OG001100.0(90.26 to 100.00)
OG002100.0(89.42 to 100.00)
OG003
66
OG00469
OG00567
66
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0005.05(4.8 to 5.3)
OG0015.00(4.8 to 5.2)
OG0025.21(5.0 to 5.4)
OG0035.05(4.8 to 5.3)
OG0045.00(4.8 to 5.2)
OG0055.24(5.0 to 5.5)
HI GMT Day 202 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0007.92(6.3 to 9.9)
OG0018.90(7.2 to 11.0)
OG0028.81(7.1 to 11.0)
OG003
HI GMT Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0005.10(4.9 to 5.3)
OG0015.00(4.8 to 5.2)
OG0025.42(5.2 to 5.7)
OG003
HI GMT Day 202 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0009.11(6.3 to 13.3)
OG00112.57(8.6 to 18.3)
OG00211.60(7.9 to 17.0)
OG003
HI GMT Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0005.00(4.6 to 5.4)
OG0015.00(4.7 to 5.4)
OG0025.00(4.6 to 5.4)
OG003
HI GMT Day 202 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0006.90(5.4 to 8.8)
OG0016.36(5.1 to 8.0)
OG0026.55(5.2 to 8.3)
OG003
MN GMT Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0005.19(4.9 to 5.5)
OG0015.27(5.0 to 5.6)
OG0025.38(5.1 to 5.7)
OG003
MN GMT Day 202 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00566
Title
Measurements
OG000113.24(94.7 to 135.4)
OG001146.98(123.6 to 174.8)
OG002146.41(122.4 to 175.1)
OG003
MN GMT Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0005.00(4.7 to 5.3)
OG0015.00(4.7 to 5.3)
OG0025.26(4.9 to 5.6)
OG003
MN GMT Day 202 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG000144.60(111.8 to 187.0)
OG001217.84(168.4 to 281.7)
OG002175.31(135.6 to 226.7)
OG003
MN GMT Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0005.38(4.9 to 5.9)
OG0015.54(5.1 to 6.0)
OG0025.49(5.0 to 6.0)
OG003
MN GMT Day 202 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00535
Title
Measurements
OG00089.38(69.6 to 114.8)
OG001101.19(79.8 to 128.2)
OG002122.19(95.1 to 157.0)
OG003
66
OG00469
OG00567
66
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0001.57(1.3 to 2.0)
OG0011.78(1.4 to 2.2)
OG0021.69(1.3 to 2.1)
OG0032.02(1.6 to 2.5)
OG0042.59(2.1 to 3.2)
OG0052.50(2.0 to 3.1)
HI GMR Day 202/Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0001.79(1.2 to 2.6)
OG0012.50(1.7 to 3.6)
OG0022.17(1.5 to 3.2)
OG003
HI GMR Day 202/Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0001.38(1.1 to 1.8)
OG0011.28(1.0 to 1.6)
OG0021.31(1.0 to 1.7)
OG003
MN GMR Day 202/Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00566
Title
Measurements
OG00021.77(18.1 to 26.1)
OG00127.94(23.4 to 33.4)
OG00227.45(22.9 to 33.0)
OG003
MN GMR Day 202/Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG00028.49(22.0 to 36.9)
OG00142.91(33.2 to 55.5)
OG00233.76(26.1 to 43.7)
OG003
MN GMR Day 202/Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00535
Title
Measurements
OG00016.64(12.8 to 21.6)
OG00118.41(14.4 to 23.5)
OG00222.38(17.3 to 29.0)
OG003
66
OG00469
OG00567
66
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG00010.4(4.30 to 20.35)
OG00114.1(6.97 to 24.38)
OG00211.9(5.30 to 22.18)
OG00315.2(7.51 to 26.10)
OG00421.7(12.71 to 33.31)
OG00525.4(15.53 to 37.49)
HI seroconversion at Day 202 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG00017.6(6.76 to 34.53)
OG00126.5(12.88 to 44.36)
OG00223.5(10.75 to 41.17)
OG003
HI seroconversion at Day 202 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0003.0(0.08 to 15.76)
OG0012.7(0.07 to 14.16)
OG0020.0(0.00 to 10.58)
OG003
MN seroconversion at Day 202 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00566
Title
Measurements
OG00095.5(87.47 to 99.07)
OG00197.2(90.19 to 99.66)
OG002100.0(94.64 to 100.00)
OG003
MN seroconversion at Day 202 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG00097.1(84.67 to 99.93)
OG001100.0(89.72 to 100.00)
OG002100.0(89.72 to 100.00)
OG003
MN seroconversion at Day 202 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00535
Title
Measurements
OG00093.9(79.77 to 99.26)
OG00194.6(81.81 to 99.34)
OG002100.0(89.42 to 100.00)
OG003
66
OG00469
OG00567
66
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0000.0(0.00 to 5.36)
OG0010.0(0.00 to 5.06)
OG0020.0(0.00 to 5.36)
OG0030.0(0.00 to 5.44)
OG0040.0(0.00 to 5.21)
OG0051.5(0.04 to 8.04)
HI titer ≥1:40 at Day 202 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG00010.4(4.30 to 20.35)
OG00114.1(6.97 to 24.38)
OG00211.9(5.30 to 22.18)
OG003
HI titer ≥1:40 at Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0000.0(0.00 to 10.28)
OG0010.0(0.00 to 10.28)
OG0020.0(0.00 to 10.28)
OG003
HI titer ≥1:40 at Day 202 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG00017.6(6.76 to 34.53)
OG00126.5(12.88 to 44.36)
OG00223.5(10.75 to 41.17)
OG003
HI titer ≥1:40 at Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000.0(0.00 to 10.58)
OG0010.0(0.00 to 9.49)
OG0020.0(0.00 to 10.58)
OG003
HI titer ≥1:40 at Day 202 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0003.0(0.08 to 15.76)
OG0012.7(0.07 to 14.16)
OG0020.0(0.00 to 10.58)
OG003
MN titer ≥1:40 at Day 1 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00567
Title
Measurements
OG0000.0(0.00 to 5.36)
OG0010.0(0.00 to 5.06)
OG0020.0(0.00 to 5.36)
OG003
MN titer ≥1:40 at Day 202 (overall study population)
ParticipantsOG00067
ParticipantsOG00171
ParticipantsOG00267
ParticipantsOG00366
ParticipantsOG00469
ParticipantsOG00566
Title
Measurements
OG00095.5(87.47 to 99.07)
OG00198.6(92.40 to 99.96)
OG002100.0(94.64 to 100.00)
OG003
MN titer ≥1:40 at Day 1 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG0000.0(0.00 to 10.28)
OG0010.0(0.00 to 10.28)
OG0020.0(0.00 to 10.28)
OG003
MN titer ≥1:40 at Day 202 (6 months to <36 months age cohort)
ParticipantsOG00034
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00333
ParticipantsOG00436
ParticipantsOG00531
Title
Measurements
OG00097.1(84.67 to 99.93)
OG001100.0(89.72 to 100.00)
OG002100.0(89.72 to 100.00)
OG003
MN titer ≥1:40 at Day 1 (3 years to <9 years age cohort)
ParticipantsOG00033
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00433
ParticipantsOG00536
Title
Measurements
OG0000.0(0.00 to 10.58)
OG0010.0(0.00 to 9.49)
OG0020.0(0.00 to 10.58)
OG003
MN titer ≥1:40 at Day 202 (3 years to <9 years age cohort)