Safety and Immunogenicity of Different Formulations of Mo... | NCT05975840 | Trialant
NCT05975840
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Aug 19, 2025Actual
Enrollment
518Actual
Phase
Phase 1Phase 2
Conditions
Influenza, Human
Interventions
FLU Q-PAN H5N8 375_B
FLU Q-PAN H5N8 375_A
FLU Q-PAN H5N8 750_B
FLU Q-PAN H5N8 750_A
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05975840
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
219833
Secondary IDs
Not provided
Brief Title
Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults
Official Title
A Phase I/II Observer-blind, Randomized, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System (Referred to as Q-Pan H5N8), Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Aug 2025
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
Aug 3, 2023Actual
Primary Completion Date
May 21, 2024Actual
Completion Date
Sep 19, 2024Actual
First Submitted Date
Jul 27, 2023
First Submission Date that Met QC Criteria
Jul 27, 2023
First Posted Date
Aug 4, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Dec 13, 2024
Results First Submitted that Met QC Criteria
Jan 30, 2025
Results First Posted Date
Feb 20, 2025Actual
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
Aug 4, 2025
Last Update Posted Date
Aug 19, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety and immunogenicity of different formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03 adjuvant system in adults greater than or equal to (>=)18 years of age.
Detailed Description
Not provided
Conditions Module
Conditions
Influenza, Human
Keywords
Influenza
Safety
Immunogenicity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
518Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Age group 18-64: FLU Q-PAN H5N8 375_B
Active Comparator
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
Biological: FLU Q-PAN H5N8 375_B
Age group 18-64: FLU Q-PAN H5N8 375_A
Active Comparator
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
Biological: FLU Q-PAN H5N8 375_A
Age group 18-64: FLU Q-PAN H5N8 750_B
Active Comparator
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
Biological: FLU Q-PAN H5N8 750_B
Age group 18-64: FLU Q-PAN H5N8 750_A
Active Comparator
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Biological: FLU Q-PAN H5N8 750_A
Age group >=65: FLU Q-PAN H5N8 375_B
Active Comparator
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
Biological: FLU Q-PAN H5N8 375_B
Age group >=65: FLU Q-PAN H5N8 375_A
Interventions
Name
Type
Description
Arm Group Labels
Other Names
FLU Q-PAN H5N8 375_B
Biological
Participants received 2 doses of 375_B vaccine formulation by intramuscular injection in the non-dominant arm.
Age group 18-64: FLU Q-PAN H5N8 375_B
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Hemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8
Antibody titers were presented as geometric mean titers (GMTs).
At Day 43
Geometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N8
The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
At Day 43
Number of Seroprotected (SP) Participants for HI Antibody Titers
Seroprotection rate is defined as the number of participants with HI titer value greater than or equal to (>=) 1:40 which is considered as indicating protection.
At Day 43
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 1
Solicited administration site events included pain, redness and swelling.
7 days (Day 1 to Day 7) following dose 1
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 2
Solicited administration site events included pain, redness and swelling.
7 days (Day 22 to Day 28) following dose 2
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1
Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature >=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Secondary Outcomes
Measure
Description
Time Frame
HI Antibody Titers Against Vaccine-homologous H5N8
Antibody titers were presented as geometric mean titers (GMTs).
Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
GMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Medically stable participants as established by medical history and clinical examination before entering into the study.
A male or female >=18 years of age at the time of signing consent form.
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
Female participants of childbearing potential or non-childbearing potential may be enrolled in the study if specific criteria are met.
Exclusion Criteria:
Current diagnosis or history of autoimmune disorder(s) except hypothyroidism due to Hashimoto's thyroiditis.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Clinically significant acute or chronic pulmonary, cardiovascular, hepatic, or renal disease that appears uncontrolled or untreated, as determined by history or physical examination.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history, physical examination, or abnormalities in screening blood tests.
Recurrent history of or uncontrolled neurological disorders or seizures.
Diagnosed with cancer, or treatment for cancer within 3 years.
Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
Persons with a history of histologically confirmed basal cell carcinoma of the skin successfully treated with local excision only, are accepted and are eligible, but other histologic types of skin cancer are exclusionary.
Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible.
Documented human immunodeficiency virus-positive participants.
Bedridden participants.
Personal or family history of narcolepsy.
Food and Drug Administration (FDA) toxicity Grade 2, or greater, laboratory tests at Screening.
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the entire study period.
Use of public health emergency vaccines like coronavirus disease 2019 (COVID-19), Monkey pox (mpox) etc. These can be given at any time, but there should a gap of 2 - weeks before a dose of study vaccine can be given.
Use of any licensed vaccines: prior to receipt of the study vaccine and continuing up to 3 weeks after receiving the dose 2 of study vaccine.
Administration of long-acting immune-modifying drugs at any time during the study period.
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose and through the entire study period. For corticosteroids, this will mean prednisone equivalent >=20 milligrams/day for 14 days or a total of >=280 mg of prednisone equivalent dose in any 14-day period. Inhaled and topical steroids are allowed.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series.
History of/or current drug/alcohol abuse.
Any study personnel or their immediate dependents, family, or household member.
Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product.
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
Biological: FLU Q-PAN H5N8 375_A
Age group >=65: FLU Q-PAN H5N8 750_B
Active Comparator
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
Biological: FLU Q-PAN H5N8 750_B
Age group >=65: FLU Q-PAN H5N8 750_A
Active Comparator
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Biological: FLU Q-PAN H5N8 750_A
Age group >=65: FLU Q-PAN H5N8 375_B
FLU Q-PAN H5N8 375_A
Biological
Participants received 2 doses of 375_A vaccine formulation by intramuscular injection in the non-dominant arm.
Age group 18-64: FLU Q-PAN H5N8 375_A
Age group >=65: FLU Q-PAN H5N8 375_A
FLU Q-PAN H5N8 750_B
Biological
Participants received 2 doses of 750_B vaccine formulation by intramuscular injection in the non-dominant arm.
Age group 18-64: FLU Q-PAN H5N8 750_B
Age group >=65: FLU Q-PAN H5N8 750_B
FLU Q-PAN H5N8 750_A
Biological
Participants received 2 doses of 750_A vaccine formulation by intramuscular injection in the non-dominant arm.
Age group 18-64: FLU Q-PAN H5N8 750_A
Age group >=65: FLU Q-PAN H5N8 750_A
7 days (Day 1 to Day 7) following dose 1
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2
Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature >=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
7 days (Day 22 to Day 28) following dose 2
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1
Hemoglobin, white blood cells (WBC) increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
7 days (Day 1 to Day 7) following dose 1
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2
Hemoglobin, WBC increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
7 days (Day 22 to Day 28) following dose 2
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1
Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin and blood urea nitrogen (BUN) were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
7 days (Day 1 to Day 7) following dose 1
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2
Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, ALT, AST, alkaline phosphatase, total bilirubin and BUN were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
7 days (Day 22 to Day 28) following dose 2
Number of Participants Reporting Unsolicited AEs Following Dose 1
An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
21 days (Day 1 to Day 22) following dose 1
Number of Participants Reporting Unsolicited AEs Following Dose 2
An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
21 days (Day 22 to Day 43) following dose 2
Number of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 1
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).
21 days (Day 1 to Day 22) following dose 1
Number of Participants Reporting Unsolicited MAEs Following Dose 2
21 days (Day 22 to Day 43) following dose 2
Number of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)
Up to 6 months post dose 2 (administered on Day 22)
Number of Participants Reporting Serious Adverse Events (SAEs) up to Day 43
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.
From Day 1 to Day 43
Number of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)
Day 1 to 6 months post dose 2 (administered on Day 22)
Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 43
pIMDs are defined a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
From Day 1 to Day 43
Number of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)
Day 1 to 6 months post dose 2 (administered on Day 22)
The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
At Day 22, and 6 months post dose 2 (administered on Day 22)
Number of Seroprotected Participants for HI Antibody Titers
Seroprotection rate is defined as the number of participants with HI titer value >= 1:40 which is considered as indicating protection.
At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
Number of Seroconverted Participants for HI Antibody Titers
HI seroconversion is defined as a post-vaccination titer >=1:40 in the serum of participants with pre-vaccination titer below 1:10 or as a >=4-fold rise in post-vaccination HI titer with pre-vaccination titer >=1:10.
At Day 22, Day 43 and 6 months post dose 2 (administered on Day 22)
Microneutralization (MN) Antibody Titers for a Subset of Participants
Microneutralization testing was performed on 50% of the participants, randomly selected and equally distributed across the different age groups.
At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
Number of Seropositive Participants for MN Antibody Titers for a Subset of Participants
A seropositive participant is a participant whose antibody titer is greater than or equal to the assay cut-off value of 1:40.
At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
Number of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants
MN VR is defined as titer >=4x LLOQ for participants with pre-vaccination titer below LLOQ or a >=4 -fold increase from pre-vaccination titer for participants with pre-vaccination titer >=LLOQ.
At Day 22, Day 43, and 6 months post dose 2 (administered on Day 22)
Mobile
Alabama
36608
United States
GSK Investigational Site
Tempe
Arizona
85281
United States
GSK Investigational Site
Chula Vista
California
91911
United States
GSK Investigational Site
Long Beach
California
90806
United States
GSK Investigational Site
Santa Ana
California
92705
United States
GSK Investigational Site
Pembroke Pines
Florida
33025
United States
GSK Investigational Site
Chamblee
Georgia
30341
United States
GSK Investigational Site
Meridian
Idaho
83642
United States
GSK Investigational Site
El Dorado
Kansas
67042
United States
GSK Investigational Site
Lenexa
Kansas
66219
United States
GSK Investigational Site
Lexington
Kentucky
40509
United States
GSK Investigational Site
Metairie
Louisiana
70006
United States
GSK Investigational Site
Anderson
South Carolina
29621
United States
GSK Investigational Site
Knoxville
Tennessee
37920
United States
GSK Investigational Site
Austin
Texas
78745
United States
GSK Investigational Site
Boerne
Texas
78006
United States
GSK Investigational Site
San Antonio
Texas
78244
United States
GSK Investigational Site
Tomball
Texas
77375
United States
GSK Investigational Site
Norfolk
Virginia
23507
United States
FG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
FG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
FG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
FG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
FG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
FG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
FG00066 subjects
FG00165 subjects
FG00264 subjects
FG00363 subjects
FG00466 subjects
FG00564 subjects
FG00666 subjects
FG00764 subjects
COMPLETED
FG00061 subjects
FG00152 subjects
FG00259 subjects
FG00359 subjects
FG00461 subjects
FG00561 subjects
FG00662 subjects
FG00758 subjects
NOT COMPLETED
FG0005 subjects
FG00113 subjects
FG0025 subjects
FG0034 subjects
FG0045 subjects
FG0053 subjects
FG0064 subjects
FG0076 subjects
Type
Comment
Reasons
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0031 subjects
FG004
Migrated/moved from the study area
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0015 subjects
FG0022 subjects
FG0032 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
The analysis population comprised of Exposed analysis set who received at least 1 dose of study vaccine. Summary of "Race/Ethnicity, Customized" baseline categorical variables are presented as de-identified to prevent risk of participant re-identification.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
BG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
BG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
BG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
BG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
BG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
BG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
BG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00066
BG00165
BG00264
BG00363
BG00466
BG00564
BG00666
BG00764
BG008518
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.
Mean
Standard Deviation
Years
Title
Denominators
Categories
18-64 Years of age
ParticipantsBG00066
ParticipantsBG00165
ParticipantsBG00264
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00066
ParticipantsBG00165
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
ParticipantsBG00066
ParticipantsBG00165
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Hemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8
Antibody titers were presented as geometric mean titers (GMTs).
Analysis was performed on the Per-protocol set (PPS) which included all eligible participants who received the 2 doses of study intervention as per protocol, had Day 1 and Day 43 post dose anti-HI immunogenicity results as per blood draw interval at Day 43. Only those participants with data available at the specified timepoint have been analyzed.
Posted
Geometric Mean
95% Confidence Interval
Titer
At Day 43
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00056
OG00146
OG00247
OG003
Title
Denominators
Categories
Title
Measurements
OG000117.5(97.0 to 141.8)
OG001175.2(142.2 to 216.0)
OG002121.8(99.2 to 150.1)
OG003
Primary
Geometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N8
The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
PPS population. Only those participants with data available at the specified timepoint have been analyzed.
Posted
Geometric Mean
95% Confidence Interval
Ratio
At Day 43
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Primary
Number of Seroprotected (SP) Participants for HI Antibody Titers
Seroprotection rate is defined as the number of participants with HI titer value greater than or equal to (>=) 1:40 which is considered as indicating protection.
PPS population. Only those participants with data available at the specified timepoint have been analyzed.
Posted
Count of Participants
Participants
At Day 43
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Primary
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 1
Solicited administration site events included pain, redness and swelling.
The analysis was performed on the Diary Set for dose 1 (DS1) which included participants who received a study intervention and provided information on at least 1 solicited adverse event (AE) on at least 1 day.
Posted
Count of Participants
Participants
7 days (Day 1 to Day 7) following dose 1
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Primary
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 2
Solicited administration site events included pain, redness and swelling.
Analysis was performed on the DS2 which included participants who received a study intervention and provided information on at least 1 solicited AE on at least 1 day.
Posted
Count of Participants
Participants
7 days (Day 22 to Day 28) following dose 2
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Primary
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1
Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature >=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
DS1 population
Posted
Count of Participants
Participants
7 days (Day 1 to Day 7) following dose 1
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Primary
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2
Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature >=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
DS2 population
Posted
Count of Participants
Participants
7 days (Day 22 to Day 28) following dose 2
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Primary
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1
Hemoglobin, white blood cells (WBC) increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
Analysis was performed on the Exposed set for dose 1 (ES1), which included participants who received a study intervention and for whom blood samples were collected and analyzed for the safety laboratory tests, at the specified timepoint.
Posted
Count of Participants
Participants
7 days (Day 1 to Day 7) following dose 1
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Primary
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2
Hemoglobin, WBC increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
Analysis was performed on the Exposed set for dose 2 (ES2), which included participants who received a study intervention and for whom blood samples were collected and analyzed for the safety laboratory tests, at the specified timepoint.
Posted
Count of Participants
Participants
7 days (Day 22 to Day 28) following dose 2
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
Primary
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1
Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin and blood urea nitrogen (BUN) were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
Analysis was performed on the Exposed set for dose 1 (ES1), which included participants who received a study intervention and for whom blood samples were collected and analyzed for the safety laboratory tests, at the specified timepoint.
Posted
Count of Participants
Participants
7 days (Day 1 to Day 7) following dose 1
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Primary
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2
Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, ALT, AST, alkaline phosphatase, total bilirubin and BUN were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
Analysis was performed on the Exposed set for dose 2 (ES2), which included participants who received a study intervention and for whom blood samples were collected and analyzed for the safety laboratory tests, at the specified timepoint.
Posted
Count of Participants
Participants
7 days (Day 22 to Day 28) following dose 2
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Primary
Number of Participants Reporting Unsolicited AEs Following Dose 1
An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Analysis was performed on the total ES population that reported unsolicited AEs for dose 1 at specified timepoints.
Posted
Count of Participants
Participants
21 days (Day 1 to Day 22) following dose 1
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Primary
Number of Participants Reporting Unsolicited AEs Following Dose 2
An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Analysis was performed on the total ES population that reported unsolicited AEs for dose 2 at specified timepoints.
Posted
Count of Participants
Participants
21 days (Day 22 to Day 43) following dose 2
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Primary
Number of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 1
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).
Analysis was performed on the total ES population that reported unsolicited MAEs for dose 1 at specified timepoints.
Posted
Count of Participants
Participants
21 days (Day 1 to Day 22) following dose 1
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Primary
Number of Participants Reporting Unsolicited MAEs Following Dose 2
Analysis was performed on the total ES population that reported unsolicited MAEs for dose 2 at specified timepoints.
Posted
Count of Participants
Participants
21 days (Day 22 to Day 43) following dose 2
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Primary
Number of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)
Analysis was performed on the total ES population that reported unsolicited MAEs for dose 2 at specified timepoints.
Posted
Count of Participants
Participants
Up to 6 months post dose 2 (administered on Day 22)
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Primary
Number of Participants Reporting Serious Adverse Events (SAEs) up to Day 43
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.
The analysis was performed on the Total ES which included participants who received a study intervention.
Posted
Count of Participants
Participants
From Day 1 to Day 43
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
Primary
Number of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)
The analysis was performed on the Total ES which included participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to 6 months post dose 2 (administered on Day 22)
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Primary
Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 43
pIMDs are defined a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
The analysis was performed on the Total ES which included participants who received a study intervention.
Posted
Count of Participants
Participants
From Day 1 to Day 43
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Secondary
HI Antibody Titers Against Vaccine-homologous H5N8
Antibody titers were presented as geometric mean titers (GMTs).
PPS population. Only those participants with data available at the specified time points have been analyzed.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Secondary
GMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8
The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
PPS population. Only those participants with data available at the specified time point have been analyzed.
Posted
Geometric Mean
95% Confidence Interval
Ratio
At Day 22, and 6 months post dose 2 (administered on Day 22)
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Secondary
Number of Seroprotected Participants for HI Antibody Titers
Seroprotection rate is defined as the number of participants with HI titer value >= 1:40 which is considered as indicating protection.
PPS population. Only those participants with data available at the specified timepoint have been analyzed.
Posted
Count of Participants
Participants
At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Secondary
Number of Seroconverted Participants for HI Antibody Titers
HI seroconversion is defined as a post-vaccination titer >=1:40 in the serum of participants with pre-vaccination titer below 1:10 or as a >=4-fold rise in post-vaccination HI titer with pre-vaccination titer >=1:10.
PPS population. Only those participants with data available at the specified timepoint have been analyzed.
Posted
Count of Participants
Participants
At Day 22, Day 43 and 6 months post dose 2 (administered on Day 22)
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Secondary
Microneutralization (MN) Antibody Titers for a Subset of Participants
Microneutralization testing was performed on 50% of the participants, randomly selected and equally distributed across the different age groups.
PPS population subset for MN testing. Only those participants with data available at the specified time points have been analyzed.
Posted
Geometric Mean
95% Confidence Interval
Titer
At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Secondary
Number of Seropositive Participants for MN Antibody Titers for a Subset of Participants
A seropositive participant is a participant whose antibody titer is greater than or equal to the assay cut-off value of 1:40.
PPS population subset for MN testing. Only those participants with data available at the specified time points have been analyzed.
Posted
Count of Participants
Participants
At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Secondary
Number of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants
MN VR is defined as titer >=4x LLOQ for participants with pre-vaccination titer below LLOQ or a >=4 -fold increase from pre-vaccination titer for participants with pre-vaccination titer >=LLOQ.
PPS population subset for MN testing. Only those participants with data available at the specified time points have been analyzed.
Posted
Count of Participants
Participants
At Day 22, Day 43, and 6 months post dose 2 (administered on Day 22)
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Primary
Number of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)
The analysis was performed on the Total ES which included participants who received a study intervention.
Posted
Count of Participants
Participants
Day 1 to 6 months post dose 2 (administered on Day 22)
ID
Title
Description
OG000
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Time Frame
SAEs, MAEs and pIMDs were reported from Day 1 to 6 months post-dose 2 (dose 2 administered on Day 22). Solicited AEs were reported from Day 1 to Day 7 and Day 22 to Day 28 (7 days after each dose). Unsolicited AEs were reported from Day 1 to Day 43.
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
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
0
66
1
66
50
66
EG001
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
1
65
1
65
40
65
EG002
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
0
64
0
64
40
64
EG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
0
63
2
63
50
63
EG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
0
66
2
66
39
66
EG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
0
64
2
64
44
64
EG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
0
66
2
66
34
66
EG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
1
64
2
64
41
64
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Septic shock
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG0030 events0 affected63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
Palpitations
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Postural orthostatic tachycardia syndrome
Cardiac disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0008 events7 affected66 at risk
EG0015 events4 affected65 at risk
EG0024 events4 affected64 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG00013 events11 affected66 at risk
EG0018 events8 affected65 at risk
EG0029 events8 affected64 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG00013 events12 affected66 at risk
EG0018 events8 affected65 at risk
EG0024 events4 affected64 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v27.0
Systematic Assessment
EG0002 events1 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Chest pain
General disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Chills
General disorders
MedDRA v27.0
Systematic Assessment
EG0009 events7 affected66 at risk
EG0019 events9 affected65 at risk
EG0024 events4 affected64 at risk
EG003
Fatigue
General disorders
MedDRA v27.0
Systematic Assessment
EG00043 events29 affected66 at risk
EG00128 events21 affected65 at risk
EG00225 events19 affected64 at risk
EG003
Fever
General disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected66 at risk
EG0012 events2 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Injection site erythema
General disorders
MedDRA v27.0
Systematic Assessment
EG0004 events4 affected66 at risk
EG0010 events0 affected65 at risk
EG0024 events3 affected64 at risk
EG003
Injection site pain
General disorders
MedDRA v27.0
Systematic Assessment
EG00070 events44 affected66 at risk
EG00153 events37 affected65 at risk
EG00248 events33 affected64 at risk
EG003
Injection site swelling
General disorders
MedDRA v27.0
Systematic Assessment
EG0005 events5 affected66 at risk
EG0010 events0 affected65 at risk
EG0023 events3 affected64 at risk
EG003
Sweating
General disorders
MedDRA v27.0
Systematic Assessment
EG00015 events12 affected66 at risk
EG00110 events8 affected65 at risk
EG0026 events5 affected64 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
COVID-19
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Latent tuberculosis
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Foreign body in eye
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected66 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Weight increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0002 events2 affected66 at risk
EG0010 events0 affected65 at risk
EG0022 events2 affected64 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG00020 events15 affected66 at risk
EG00116 events14 affected65 at risk
EG0026 events5 affected64 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG00040 events29 affected66 at risk
EG00133 events25 affected65 at risk
EG00225 events17 affected64 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Brain fog
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Headache
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG00039 events30 affected66 at risk
EG00118 events15 affected65 at risk
EG00214 events12 affected64 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0001 events1 affected66 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Injection site pruritus
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Pyrexia
General disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Blood urea increased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Syncope
Nervous system disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Hypertension
Vascular disorders
MedDRA v27.0
Systematic Assessment
EG0000 events0 affected66 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Other, combined to maintain patient confidentiality
ParticipantsBG00066
ParticipantsBG00165
ParticipantsBG00264
ParticipantsBG00363
ParticipantsBG00466
ParticipantsBG00564
ParticipantsBG00666
ParticipantsBG00764
ParticipantsBG008518
Title
Measurements
BG00032
BG00124
BG00225
BG003
49
OG00447
OG00540
OG00643
OG00744
176.6
(144.2 to 216.2)
OG00480.6(64.3 to 101.1)
OG005110.2(85.3 to 139.7)
OG00684.0(66.6 to 107.0)
OG007129.3(102.7 to 164.1)
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00056
OG00146
OG00247
OG00349
OG00447
OG00540
OG00643
OG00744
Title
Denominators
Categories
Title
Measurements
OG00021.7(18.3 to 26.7)
OG00133.0(26.8 to 40.7)
OG00223.7(18.7 to 28.3)
OG00333.1(27.2 to 40.7)
OG00411.7(9.3 to 14.6)
OG00514.3(12.3 to 20.2)
OG00612.8(9.6 to 15.4)
OG00719.5(14.8 to 23.7)
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00056
OG00146
OG00247
OG00349
OG00447
OG00540
OG00643
OG00744
Title
Denominators
Categories
Title
Measurements
OG00056
OG00145
OG00246
OG00349
OG00443
OG00537
OG00641
OG00741
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00065
OG00159
OG00262
OG00363
OG00464
OG00563
OG00664
OG00764
Title
Denominators
Categories
Pain
Title
Measurements
OG00039
OG00134
OG00227
OG00338
OG00423
OG00522
OG00614
OG00729
Redness
Title
Measurements
OG0003
OG0010
OG0022
OG003
Swelling
Title
Measurements
OG0002
OG0010
OG0022
OG003
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00063
OG00152
OG00253
OG00355
OG00449
OG00545
OG00649
OG00749
Title
Denominators
Categories
Pain
Title
Measurements
OG00031
OG00119
OG00221
OG00324
OG00417
OG00514
OG00612
OG00715
Redness
Title
Measurements
OG0001
OG0010
OG0022
OG003
Swelling
Title
Measurements
OG0003
OG0010
OG0021
OG003
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00065
OG00159
OG00262
OG00363
OG00464
OG00563
OG00664
OG00764
Title
Denominators
Categories
Fatigue
Title
Measurements
OG00025
OG00118
OG00215
OG00320
OG0049
OG00513
OG0066
OG00712
Fever
Title
Measurements
OG0002
OG0010
OG0020
OG003
Headache
Title
Measurements
OG00019
OG00112
OG00210
OG003
Muscle ache
Title
Measurements
OG00023
OG00122
OG00215
OG003
Joint pain
Title
Measurements
OG00012
OG0019
OG0023
OG003
Shivering (chills)
Title
Measurements
OG0006
OG0017
OG0021
OG003
Sweating
Title
Measurements
OG00010
OG0017
OG0023
OG003
Nausea
Title
Measurements
OG00011
OG0016
OG0024
OG003
Vomiting
Title
Measurements
OG0001
OG0010
OG0020
OG003
Diarrhea
Title
Measurements
OG0007
OG0014
OG0026
OG003
Abdominal pain
Title
Measurements
OG0006
OG0013
OG0022
OG003
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00063
OG00152
OG00253
OG00355
OG00449
OG00545
OG00649
OG00749
Title
Denominators
Categories
Fatigue
Title
Measurements
OG00018
OG0019
OG00210
OG00311
OG0045
OG00512
OG0064
OG0078
Fever
Title
Measurements
OG0000
OG0012
OG0020
OG003
Headache
Title
Measurements
OG00019
OG0016
OG0024
OG003
Muscle ache
Title
Measurements
OG00017
OG00110
OG00210
OG003
Joint pain
Title
Measurements
OG0008
OG0016
OG0023
OG003
Shivering (chills)
Title
Measurements
OG0003
OG0012
OG0023
OG003
Sweating
Title
Measurements
OG0005
OG0013
OG0023
OG003
Nausea
Title
Measurements
OG0002
OG0012
OG0020
OG003
Vomiting
Title
Measurements
OG0001
OG0010
OG0020
OG003
Diarrhea
Title
Measurements
OG0006
OG0013
OG0023
OG003
Abdominal pain
Title
Measurements
OG0002
OG0012
OG0022
OG003
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00033
OG00134
OG00233
OG00332
OG00432
OG00536
OG00635
OG00736
Title
Denominators
Categories
Hemoglobin
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00332
ParticipantsOG00432
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0002
OG0015
OG0021
OG003
WBC Increase
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00332
WBC Decrease
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00332
Platelets
ParticipantsOG00033
ParticipantsOG00133
ParticipantsOG00233
ParticipantsOG00332
Neutrophils Absolute
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00332
Lymphocytes Absolute
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00332
Eosinophils Absolute
ParticipantsOG00031
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00330
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00031
OG00124
OG00229
OG00328
OG00423
OG00523
OG00622
OG00723
Title
Denominators
Categories
Hemoglobin
ParticipantsOG00031
ParticipantsOG00124
ParticipantsOG00229
ParticipantsOG00328
ParticipantsOG00423
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0005
OG0013
OG0023
OG003
WBC Increase
ParticipantsOG00031
ParticipantsOG00124
ParticipantsOG00228
ParticipantsOG00327
WBC Decrease
ParticipantsOG00031
ParticipantsOG00124
ParticipantsOG00228
ParticipantsOG00327
Platelets
ParticipantsOG00031
ParticipantsOG00124
ParticipantsOG00229
ParticipantsOG00328
Neutrophils Absolute
ParticipantsOG00031
ParticipantsOG00124
ParticipantsOG00229
ParticipantsOG00328
Lymphocytes Absolute
ParticipantsOG00031
ParticipantsOG00124
ParticipantsOG00229
ParticipantsOG00328
Eosinophils Absolute
ParticipantsOG00030
ParticipantsOG00124
ParticipantsOG00226
ParticipantsOG00325
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00033
OG00134
OG00233
OG00333
OG00434
OG00536
OG00635
OG00736
Title
Denominators
Categories
Sodium Increase
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00333
ParticipantsOG00434
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0001
OG0011
OG0020
OG003
Sodium Decrease
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00333
Potassium Increase
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00333
Potassium Decrease
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00333
Creatinine
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00333
ALT
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00332
AST
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00333
Alkaline Phosphatase
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00333
Total Bilirubin
ParticipantsOG00029
ParticipantsOG00130
ParticipantsOG00232
ParticipantsOG00329
BUN
ParticipantsOG00033
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00333
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00032
OG00126
OG00229
OG00328
OG00424
OG00523
OG00622
OG00723
Title
Denominators
Categories
Sodium Increase
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00328
ParticipantsOG00424
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sodium Decrease
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00328
Potassium Increase
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00328
Potassium Decrease
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00328
Creatinine
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00328
ALT
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00327
AST
ParticipantsOG00030
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00328
Alkaline Phosphatase
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00328
Total Bilirubin
ParticipantsOG00031
ParticipantsOG00126
ParticipantsOG00226
ParticipantsOG00325
BUN
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00328
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00066
OG00165
OG00264
OG00363
OG00466
OG00564
OG00666
OG00764
Title
Denominators
Categories
Title
Measurements
OG0004
OG0016
OG0027
OG0037
OG0044
OG0055
OG0065
OG0078
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00063
OG00152
OG00254
OG00355
OG00449
OG00545
OG00649
OG00749
Title
Denominators
Categories
Title
Measurements
OG0003
OG0014
OG0022
OG0033
OG0046
OG0053
OG0063
OG0071
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00066
OG00165
OG00264
OG00363
OG00466
OG00564
OG00666
OG00764
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
OG0023
OG0033
OG0042
OG0051
OG0061
OG0073
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00063
OG00152
OG00254
OG00355
OG00449
OG00545
OG00649
OG00749
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0021
OG0032
OG0041
OG0050
OG0062
OG0070
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00066
OG00165
OG00264
OG00363
OG00466
OG00564
OG00666
OG00764
Title
Denominators
Categories
Title
Measurements
OG0004
OG0016
OG0026
OG0038
OG0046
OG0056
OG00611
OG0078
OG003
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00066
OG00165
OG00264
OG00363
OG00466
OG00564
OG00666
OG00764
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0020
OG0032
OG0040
OG0050
OG0061
OG0071
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00066
OG00165
OG00264
OG00363
OG00466
OG00564
OG00666
OG00764
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0020
OG0032
OG0042
OG0052
OG0062
OG0072
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00066
OG00165
OG00264
OG00363
OG00466
OG00564
OG00666
OG00764
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00064
OG00162
OG00259
OG00356
OG00462
OG00556
OG00660
OG00760
Title
Denominators
Categories
Day 1
ParticipantsOG00064
ParticipantsOG00162
ParticipantsOG00259
ParticipantsOG00356
ParticipantsOG00462
ParticipantsOG00556
ParticipantsOG00660
ParticipantsOG00760
Title
Measurements
OG0005.4(5.0 to 5.8)
OG0015.2(5.0 to 5.5)
OG0025.2(5.0 to 5.4)
OG003
Day 22
ParticipantsOG00059
ParticipantsOG00147
ParticipantsOG00249
ParticipantsOG00352
6 months post dose 2
ParticipantsOG00053
ParticipantsOG00145
ParticipantsOG00244
ParticipantsOG00348
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00059
OG00147
OG00249
OG00352
OG00447
OG00540
OG00644
OG00746
Title
Denominators
Categories
Day 22
ParticipantsOG00059
ParticipantsOG00147
ParticipantsOG00249
ParticipantsOG00352
ParticipantsOG00447
ParticipantsOG00540
ParticipantsOG00644
ParticipantsOG00746
Title
Measurements
OG0009.1(7.6 to 11.1)
OG00110.2(8.3 to 12.6)
OG00210.2(8.2 to 12.3)
OG003
6 months post dose 2
ParticipantsOG00053
ParticipantsOG00145
ParticipantsOG00244
ParticipantsOG00348
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00064
OG00162
OG00259
OG00356
OG00462
OG00556
OG00660
OG00760
Title
Denominators
Categories
Day 1
ParticipantsOG00064
ParticipantsOG00162
ParticipantsOG00259
ParticipantsOG00356
ParticipantsOG00462
ParticipantsOG00556
ParticipantsOG00660
ParticipantsOG00760
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 22
ParticipantsOG00059
ParticipantsOG00147
ParticipantsOG00249
ParticipantsOG00352
6 months post dose 2
ParticipantsOG00053
ParticipantsOG00145
ParticipantsOG00244
ParticipantsOG00348
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00059
OG00147
OG00249
OG00352
OG00447
OG00540
OG00644
OG00746
Title
Denominators
Categories
Day 22
ParticipantsOG00059
ParticipantsOG00147
ParticipantsOG00249
ParticipantsOG00352
ParticipantsOG00447
ParticipantsOG00540
ParticipantsOG00644
ParticipantsOG00746
Title
Measurements
OG00040
OG00139
OG00239
OG003
Day 43
ParticipantsOG00056
ParticipantsOG00146
ParticipantsOG00247
ParticipantsOG00349
6 months post dose 2
ParticipantsOG00053
ParticipantsOG00145
ParticipantsOG00244
ParticipantsOG00348
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00032
OG00131
OG00231
OG00326
OG00432
OG00529
OG00629
OG00729
Title
Denominators
Categories
Day 1
ParticipantsOG00032
ParticipantsOG00131
ParticipantsOG00231
ParticipantsOG00326
ParticipantsOG00432
ParticipantsOG00529
ParticipantsOG00629
ParticipantsOG00729
Title
Measurements
OG0005.0(NA to NA)95% CI not calculated as there was no variation in the micro neutralizing titer at visit 1 and it was below level of detection (i.e., below lower limit of quantification) for all participants in this group.
OG0015.0(NA to NA)95% CI not calculated as there was no variation in the micro neutralizing titer at visit 1 and it was below level of detection (i.e., below lower limit of quantification) for all participants in this group.
OG0025.0(NA to NA)95% CI not calculated as there was no variation in the micro neutralizing titer at visit 1 and it was below level of detection (i.e., below lower limit of quantification) for all participants in this group.
Day 22
ParticipantsOG00030
ParticipantsOG00122
ParticipantsOG00228
ParticipantsOG00325
6 months post dose 2
ParticipantsOG00026
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00324
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00032
OG00131
OG00231
OG00326
OG00432
OG00529
OG00629
OG00729
Title
Denominators
Categories
Day 1
ParticipantsOG00032
ParticipantsOG00131
ParticipantsOG00231
ParticipantsOG00326
ParticipantsOG00432
ParticipantsOG00529
ParticipantsOG00629
ParticipantsOG00729
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 22
ParticipantsOG00030
ParticipantsOG00122
ParticipantsOG00228
ParticipantsOG00325
6 months post dose 2
ParticipantsOG00026
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00324
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
OG004
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00030
OG00122
OG00228
OG00325
OG00424
OG00517
OG00621
OG00723
Title
Denominators
Categories
Day 22
ParticipantsOG00030
ParticipantsOG00122
ParticipantsOG00228
ParticipantsOG00325
ParticipantsOG00424
ParticipantsOG00517
ParticipantsOG00621
ParticipantsOG00723
Title
Measurements
OG0000
OG0012
OG0021
OG003
Day 43
ParticipantsOG00029
ParticipantsOG00121
ParticipantsOG00227
ParticipantsOG00325
6 months post dose 2
ParticipantsOG00026
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00324
Participants received 2 doses of 375_B vaccine formulation, 21 days apart.
OG005
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375_A vaccine formulation, 21 days apart.
OG006
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750_B vaccine formulation, 21 days apart.
OG007
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750_A vaccine formulation, 21 days apart.
Units
Counts
Participants
OG00066
OG00165
OG00264
OG00363
OG00466
OG00564
OG00666
OG00764
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
1 events
1 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
1 events
1 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0071 events1 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0061 events1 affected66 at risk
EG0071 events1 affected64 at risk
0 events
0 affected
63 at risk
EG0041 events1 affected66 at risk
EG0052 events2 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0061 events1 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0041 events1 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0041 events1 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0041 events1 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0071 events1 affected64 at risk
0 events
0 affected
63 at risk
EG0041 events1 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
1 events
1 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
11 events
6 affected
63 at risk
EG0048 events7 affected66 at risk
EG0054 events4 affected64 at risk
EG0067 events5 affected66 at risk
EG0075 events4 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
8 events
6 affected
63 at risk
EG0043 events3 affected66 at risk
EG0052 events2 affected64 at risk
EG0066 events5 affected66 at risk
EG0074 events4 affected64 at risk
15 events
9 affected
63 at risk
EG0046 events5 affected66 at risk
EG0055 events4 affected64 at risk
EG0066 events5 affected66 at risk
EG0076 events4 affected64 at risk
1 events
1 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
6 events
3 affected
63 at risk
EG0041 events1 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0071 events1 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
8 events
8 affected
63 at risk
EG0046 events5 affected66 at risk
EG0053 events3 affected64 at risk
EG0061 events1 affected66 at risk
EG0075 events4 affected64 at risk
31 events
24 affected
63 at risk
EG00414 events11 affected66 at risk
EG00525 events16 affected64 at risk
EG00610 events9 affected66 at risk
EG00720 events15 affected64 at risk
1 events
1 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0072 events2 affected64 at risk
4 events
3 affected
63 at risk
EG0040 events0 affected66 at risk
EG0052 events1 affected64 at risk
EG0060 events0 affected66 at risk
EG0077 events5 affected64 at risk
62 events
41 affected
63 at risk
EG00440 events27 affected66 at risk
EG00536 events25 affected64 at risk
EG00626 events18 affected66 at risk
EG00744 events31 affected64 at risk
3 events
3 affected
63 at risk
EG0042 events2 affected66 at risk
EG0052 events1 affected64 at risk
EG0060 events0 affected66 at risk
EG0077 events5 affected64 at risk
12 events
10 affected
63 at risk
EG00410 events7 affected66 at risk
EG0054 events3 affected64 at risk
EG0062 events2 affected66 at risk
EG0075 events4 affected64 at risk
1 events
1 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
1 events
1 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0071 events1 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0061 events1 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0052 events2 affected64 at risk
EG0060 events0 affected66 at risk
EG0071 events1 affected64 at risk
1 events
1 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
1 events
1 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0042 events2 affected66 at risk
EG0051 events1 affected64 at risk
EG0061 events1 affected66 at risk
EG0071 events1 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
15 events
11 affected
63 at risk
EG0045 events5 affected66 at risk
EG00510 events9 affected64 at risk
EG0067 events6 affected66 at risk
EG00710 events8 affected64 at risk
41 events
30 affected
63 at risk
EG00415 events12 affected66 at risk
EG00519 events15 affected64 at risk
EG00611 events8 affected66 at risk
EG00723 events17 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
1 events
1 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0041 events1 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
25 events
18 affected
63 at risk
EG00414 events10 affected66 at risk
EG00516 events13 affected64 at risk
EG00610 events8 affected66 at risk
EG00717 events13 affected64 at risk
0 events
0 affected
63 at risk
EG0042 events2 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0071 events1 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0051 events1 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0041 events1 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0051 events1 affected64 at risk
EG0060 events0 affected66 at risk
EG0071 events1 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0051 events1 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0061 events1 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0041 events1 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0051 events1 affected64 at risk
EG0061 events1 affected66 at risk
EG0071 events1 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0061 events1 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0051 events1 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0051 events1 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0072 events2 affected64 at risk
0 events
0 affected
63 at risk
EG0041 events1 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0042 events2 affected66 at risk
EG0050 events0 affected64 at risk
EG0060 events0 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0061 events1 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0061 events1 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0061 events1 affected66 at risk
EG0070 events0 affected64 at risk
0 events
0 affected
63 at risk
EG0040 events0 affected66 at risk
EG0050 events0 affected64 at risk
EG0061 events1 affected66 at risk
EG0070 events0 affected64 at risk
71.0
± 5.2
BG00871.5± 5.1
31
BG00532
BG00625
BG00728
BG008247
25
BG00412
BG00514
BG00614
BG00717
BG008163
2
OG0040
OG0051
OG0060
OG0074
2
OG0042
OG0051
OG0060
OG0075
2
OG0040
OG0051
OG0060
OG0073
1
OG0040
OG0051
OG0060
OG0072
0
OG0040
OG0050
OG0060
OG0071
15
OG0049
OG00512
OG0065
OG00712
26
OG0049
OG00512
OG0068
OG00716
9
OG0042
OG0059
OG0064
OG0076
5
OG0045
OG0052
OG0060
OG0074
7
OG0046
OG0052
OG0062
OG0074
7
OG0045
OG0052
OG0065
OG0074
1
OG0040
OG0050
OG0060
OG0071
5
OG0042
OG0051
OG0064
OG0073
4
OG0047
OG0053
OG0065
OG0074
1
OG0040
OG0050
OG0060
OG0071
10
OG0045
OG0054
OG0064
OG0075
15
OG0046
OG0057
OG0063
OG0077
6
OG0043
OG0051
OG0062
OG0074
3
OG0041
OG0051
OG0061
OG0071
5
OG0044
OG0052
OG0060
OG0071
6
OG0041
OG0053
OG0061
OG0072
3
OG0041
OG0050
OG0060
OG0070
3
OG0041
OG0051
OG0062
OG0071
6
OG0041
OG0051
OG0061
OG0071
6
OG0047
OG0056
OG0067
OG0077
Participants
OG004
32
ParticipantsOG00536
ParticipantsOG00634
ParticipantsOG00735
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0041
OG0052
OG0060
OG0071
Participants
OG004
32
ParticipantsOG00536
ParticipantsOG00634
ParticipantsOG00735
Title
Measurements
OG0002
OG0012
OG0020
OG0033
OG0040
OG0051
OG0061
OG0070
Participants
OG004
32
ParticipantsOG00535
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0071
ParticipantsOG00432
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0003
OG0011
OG0022
OG0033
OG0040
OG0052
OG0061
OG0071
ParticipantsOG00432
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0055
OG0061
OG0070
ParticipantsOG00432
ParticipantsOG00535
ParticipantsOG00633
ParticipantsOG00736
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0061
OG0070
2
OG0042
OG0054
OG0063
OG0074
Participants
OG004
23
ParticipantsOG00523
ParticipantsOG00621
ParticipantsOG00722
Title
Measurements
OG0002
OG0012
OG0021
OG0030
OG0041
OG0051
OG0060
OG0072
Participants
OG004
23
ParticipantsOG00523
ParticipantsOG00621
ParticipantsOG00722
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
Participants
OG004
23
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
ParticipantsOG00423
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00722
Title
Measurements
OG0002
OG0010
OG0023
OG0030
OG0040
OG0050
OG0060
OG0070
ParticipantsOG00423
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00722
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0051
OG0061
OG0071
ParticipantsOG00422
ParticipantsOG00522
ParticipantsOG00621
ParticipantsOG00722
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0041
OG0051
OG0061
OG0070
0
OG0040
OG0052
OG0061
OG0070
ParticipantsOG00434
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0002
OG0013
OG0023
OG0031
OG0044
OG0054
OG0065
OG0074
ParticipantsOG00434
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0001
OG0011
OG0026
OG0031
OG0045
OG0057
OG0062
OG0075
ParticipantsOG00434
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0001
OG0011
OG0024
OG0031
OG0040
OG0050
OG0061
OG0074
Participants
OG004
34
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0051
OG0060
OG0070
Participants
OG004
33
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0000
OG0011
OG0021
OG0031
OG0042
OG0051
OG0060
OG0072
Participants
OG004
34
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0000
OG0011
OG0022
OG0030
OG0040
OG0050
OG0063
OG0074
ParticipantsOG00434
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0001
OG0013
OG0022
OG0030
OG0044
OG0053
OG0062
OG0073
ParticipantsOG00433
ParticipantsOG00535
ParticipantsOG00634
ParticipantsOG00736
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
Participants
OG004
34
ParticipantsOG00536
ParticipantsOG00635
ParticipantsOG00736
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0042
OG0055
OG0064
OG0072
0
OG0041
OG0051
OG0060
OG0070
ParticipantsOG00424
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0001
OG0012
OG0021
OG0032
OG0041
OG0052
OG0062
OG0071
ParticipantsOG00424
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0002
OG0011
OG0021
OG0031
OG0044
OG0051
OG0064
OG0073
ParticipantsOG00424
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0071
Participants
OG004
24
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
Participants
OG004
23
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0001
OG0013
OG0021
OG0031
OG0040
OG0050
OG0060
OG0070
Participants
OG004
24
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0040
OG0051
OG0064
OG0070
ParticipantsOG00424
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0001
OG0013
OG0020
OG0030
OG0043
OG0052
OG0062
OG0073
ParticipantsOG00424
ParticipantsOG00523
ParticipantsOG00621
ParticipantsOG00722
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants
OG004
24
ParticipantsOG00523
ParticipantsOG00622
ParticipantsOG00723
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0041
OG0053
OG0061
OG0075
5.4
(4.9 to 5.9)
OG0046.7(5.9 to 7.6)
OG0057.7(6.6 to 9.1)
OG0066.4(5.9 to 7.1)
OG0076.6(5.9 to 7.4)
Participants
OG004
47
ParticipantsOG00540
ParticipantsOG00644
ParticipantsOG00746
Title
Measurements
OG00049.1(40.5 to 59.0)
OG00154.2(43.8 to 66.8)
OG00252.7(43.2 to 65.3)
OG00356.5(46.2 to 69.0)
OG00440.2(31.4 to 51.5)
OG00539.7(28.8 to 49.5)
OG00644.7(35.4 to 59.1)
OG00754.5(43.3 to 71.5)
ParticipantsOG00444
ParticipantsOG00536
ParticipantsOG00644
ParticipantsOG00740
Title
Measurements
OG00023.7(19.8 to 27.9)
OG00126.4(21.9 to 31.8)
OG00226.5(22.2 to 32.4)
OG00330.8(25.7 to 36.8)
OG00425.5(20.7 to 31.0)
OG00528.5(22.3 to 35.0)
OG00625.3(20.9 to 31.4)
OG00729.0(23.7 to 36.2)
10.6
(8.7 to 13.0)
OG0045.8(4.5 to 7.5)
OG0055.1(4.2 to 7.2)
OG0066.9(5.1 to 8.6)
OG0078.3(6.3 to 10.4)
ParticipantsOG00444
ParticipantsOG00536
ParticipantsOG00644
ParticipantsOG00740
Title
Measurements
OG0004.3(3.7 to 5.2)
OG0015.0(4.1 to 6.0)
OG0025.1(4.2 to 6.1)
OG0035.8(4.8 to 6.9)
OG0043.6(3.0 to 4.5)
OG0053.9(3.2 to 5.0)
OG0063.8(3.0 to 4.5)
OG0074.3(3.4 to 5.2)
1
OG0041
OG0051
OG0060
OG0070
Participants
OG004
47
ParticipantsOG00540
ParticipantsOG00644
ParticipantsOG00746
Title
Measurements
OG00040
OG00140
OG00239
OG00343
OG00425
OG00524
OG00629
OG00733
ParticipantsOG00444
ParticipantsOG00536
ParticipantsOG00644
ParticipantsOG00740
Title
Measurements
OG00014
OG00120
OG00217
OG00325
OG00414
OG00517
OG00613
OG00720
42
OG00421
OG00521
OG00629
OG00731
Participants
OG004
47
ParticipantsOG00540
ParticipantsOG00643
ParticipantsOG00744
Title
Measurements
OG00055
OG00145
OG00246
OG00349
OG00439
OG00536
OG00640
OG00740
ParticipantsOG00444
ParticipantsOG00536
ParticipantsOG00644
ParticipantsOG00740
Title
Measurements
OG00013
OG00120
OG00217
OG00324
OG00412
OG00514
OG00612
OG00720
OG0035.1(4.9 to 5.4)
OG0045.0(NA to NA)95% CI not calculated as there was no variation in the micro neutralizing titer at visit 1 and it was below level of detection (i.e., below lower limit of quantification) for all participants in this group.
OG0055.2(4.8 to 5.6)
OG0065.1(4.9 to 5.4)
OG0075.0(NA to NA)95% CI not calculated as there was no variation in the micro neutralizing titer at visit 1 and it was below level of detection (i.e., below lower limit of quantification) for all participants in this group.