Skip to content

A Laboratory Evaluation of the Humoral Immune Response in Adults and Children to the H1 Hemagglutinin (HA) Stalk Domain and Other Influenza A Virus Protein Epitopes, After Administration of GlaxoSmithKline (GSK) Biologicals' Pandemic Influenza Vaccines

An Exploratory, Retrospective Laboratory Evaluation of the Humoral Immune Response in Adults and Children to the H1 HA Stalk Domain and Other Influenza A Virus Protein Epitopes, After Administration of GSK Biologicals' Pandemic Influenza Vaccines

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02415842
Enrollment
414
Registered
2015-04-14
Start date
2015-10-26
Completion date
2018-02-16
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunologic Tests

Keywords

Supra-seasonal influenza vaccine, Pandemic, Exploratory, Protein epitopes, Laboratory evaluation, Retrospective

Brief summary

The purpose of this exploratory, retrospective laboratory study is to assess the humoral immune response to H1 hemagglutinin stalk domain and other influenza A virus protein epitopes following administration, in adults and children, of GSK Biologicals' adjuvanted and unadjuvanted pandemic influenza vaccines, using archived serum samples from previously completed clinical trials.

Interventions

The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.

Sponsors

Icahn School of Medicine at Mount Sinai
CollaboratorOTHER
GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 64 Years
Healthy volunteers
Yes

Inclusion criteria

Not applicable since no subjects will be actively enrolled in this study; only the sera samples of the subjects who were a part of previously conducted primary trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study: * Subjects who received two doses of influenza vaccine 21 days apart and were included in the ATP cohort for immunogenicity and Persistence cohort (depending on the study) in the primary studies listed. * Subjects who had agreed that their blood samples could be used for further research while giving informed consent for any of the primary studies listed. * Subjects who have sufficient residual sample volume (i.e., ≥0.5 mL) of serum at all time points. * Subjects with vaccine homologous neutralizing antibody result available at Day 0 and at 21 (25 samples available per group in Study H9N2-001)

Exclusion criteria

* Not applicable since no subjects will be actively enrolled in this study; only the serum samples of the subjects who were a part of previously conducted trials will be used for testing.

Design outcomes

Primary

MeasureTime frameDescription
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 CohortAt D21 (post-dose1) compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortGroup C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 CohortFor group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortAt Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 CohortAt D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortAt D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 CohortAt D21 (post-dose1 compared to [/]D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)With respect to samples from Hemagglutinin (HA) Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL).
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 21 (post-vaccination 1 compared to pre-vaccination), Day 42 (post-vaccination 2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. Seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL).
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortAt Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL).
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortAt Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL).
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortFor group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182); at Day 591 (post-dose3 / Day 182)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortFor group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration. The ≥10-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortAt Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 CohortAt D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 CohortAt D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration. The ≥10-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortAt D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 CohortAt D21 (post-dose1 compared to [/]D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 CohortAt D21 (post-dose1 compared to [/]D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 CohortAt D21 (post-dose1) compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by microneutralization (MN) for all subjects who received an adjuvant system (AS) vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution (1/DIL).
Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.
Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS VaccinesAt Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortGroup C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortGroup C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 CohortFor group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 CohortFor group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer. The ≥10-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortAt Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 CohortAt D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 CohortAt D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortAt D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
Anti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult FLU D-QIV-015 CohortAt D21 (post-dose1 compared to [/]D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult FLU D-QIV-015 CohortAt D21 (post-dose1 compared to [/]D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 CohortAt D21 (post-dose1) compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
Anti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 42 (post-vaccination2 compared to Day 0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohortand for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385[post-vaccination2]/ Day 0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortAt D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortAt D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 CohortFor group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortAt Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 CohortAt D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortAt D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 CohortAt D21 (post-dose1 compared to [/]D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 CohortAt D21 (post-dose1) compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
Anti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 42 (post-vaccination2 compared to Day 0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohortand for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortAt Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385(post-vaccination2/ Day 0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortAt D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortAt D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 CohortFor group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortAt Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 CohortAt D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortAt D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 CohortAt D21 (post-dose1 compared to [/]D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 CohortAt D21 (post-dose1) compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.
Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution )
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 42 (post-vaccination2/ pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.
RG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 42 (post-vaccination2/ pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortGroup C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortGroup C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 CohortFor group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortAt Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 CohortAt D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortAt D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult FLU D-QIV-015 CohortAt D21 (post-dose1 compared to [/]D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 CohortAt D21 (post-dose1 compared to D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution ).
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 42 (post-vaccination2/ pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.
H1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS VaccinesAt Day 42 (post-vaccination2/ pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortGroup C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.
H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortGroup C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 CohortFor group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortAt Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group GWith respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortAt D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 CohortAt D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortAt D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortAt D0 (Pre), D21 (Post-dose 1)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 CohortAt D21 (post-dose1 compared to [/]D0)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 CohortAt D21 (post-dose1) compared to D0With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution).
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)At Day 42 (post-vaccination2/ pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.
H1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 42 (post-vaccination2 compared to pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)At Day 42 (post-vaccination2/ pre-vaccination)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.
Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortGroup C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

Secondary

MeasureTime frameDescription
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 CohortAt D21, D42, D182 and Day 385With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 CohortAt D21, D42 and D182With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 CohortAt D21, D42, and D182 (compared to Day 0)With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 CohortAt D21, D42, D182 and Day 385 (compared to Day 0)With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 CohortAt D21, D42 and D182 (compared to Day 0)With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.
Number of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsAt Day 0With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at baseline (Day 0) for the HI assay against the pandemic vaccine homologous virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 cohorts. Seronegative subjects = Subjects with antibody titer \< 10 1/DIL for Pandemic vaccine homologous virus and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Pandemic vaccine homologous virus (i.e., A/California/7/2009 for subjects from the Q-PAN H1N1-019 study, A/Indonesia/5/2005 for subjects from CC-PAN H5N1-001 study, A/chicken/Hong Kong/G9/1997 for subjects from Q-PAN H9N2-001 study).
Number of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsAt Day 0, (except for group G of Q-PAN-005, at Day182)With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at baseline (at Day 0 in all subjects except for group G of Q-PAN-005 \[i.e, at Day182\]) for the HI assay against the pandemic vaccine homologous virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 cohorts . Seronegative subjects = Subjects with antibody titer \< 10 1/DIL for Pandemic vaccine homologous virus and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Pandemic vaccine homologous virus (i.e., for FLU D-QIV-015: A/Christchurch/16/2010 at Day 0, for Q-PAN-005 study, group C: A/Turkey/01/2005 and A/Indonesia/5/2005 at Day 0 and for group G, A/Turkey/01/2005 at Day 182, for H5N1-012 study, for group VT/VT/12M : A/Vietnam/1194/2004 at Day 0, for group VT/IN/12M, A/Indonesia/5/2005 and A/Vietnam/1194/2004-like at Day 0).
Number of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsAt Day 0With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at pre-vaccination (Baseline) for the HI assay against A/California/7/09 virus (or like virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 cohorts. Seronegative subjects = Subjects with antibody titer \< 10 1/DIL for A/California/7/09 virus (or like virus) and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for A/California/7/09 virus (or like virus).
Number of Subjects With Seropositivity Status Against Flu A/Indonesia/05/2005 (H5N1) HI Antibodies - Pediatric H5N1 CohortAt Day 0With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status against Flu A/Indonesia/05/2005 (H5N1) HI antibodies - Pediatric H5N1 cohort. Seronegative subjects = Subjects with antibody titer \< 10 1/DIL for Flu A/Ind/05/05 (H5N1).HA HI prior to vaccination and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Flu A/Ind/05/05 (H5N1).HA HI prior to vaccination.
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 CohortAt D21, D42, and D182With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).

Countries

United States

Participant flow

Recruitment details

Subjects analyzed in this study were subjects enrolled and analyzed in the According-to-Protocol (ATP)cohort for immunogenicity from Hemagglutinin (HA) Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines).

Pre-assignment details

The HA Group 1-related studies were the followings: (FLU Q-PAN H1N1-019; \[113536\]; FLU CC-PAN H5N1-001\[114371\]; FLU Q-PAN H9N2-001\[116358\]; FLU Q-PAN-005\[110624\]; H5N1-012\[107495\]; FLU D-QIV-015\[201251\] and FLU Q-PAN H5N1-AS03-021\[114464\]).

Participants by arm

ArmCount
H1N1_AS
Subjects 19-40 years of age (in H1N1 cohort of primary completed study Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
29
H1N1_NAS
Subjects 19-40 years of age (in H1N1 cohort of primary completed study -Q-PAN H1N1-019 (113536) (A/California/07/2009)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and TIV at Day 42
29
H5N1_AS
Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21
29
H5N1_NAS
Subjects 18-49 years of age (in H5N1 cohort of primary completed study CC-PAN H5N1-001 (114371)(A/Indonesia/5/2005 RG)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21
27
H9N2_AS
Subjects 18-64 years of age (in H9N2 cohort of primary completed study Q-PAN H9N2-001 (116358) (A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered adjuvanted (AS03A) pandemic vaccine with 3.75 µg HA (hemagglutinin) at Days 0 and 21 and saline placebo at Day 182.
30
H9N2_NAS
Subjects 18-64 years of age (in H9N2 cohort of primary completed studyQ-PAN H9N2-001 (116358)(A/chicken/Hong Kong/G9/1997 NIBRG-91)) who were administered unadjuvanted pandemic vaccine with 15 µg HA (hemagglutinin) at Days 0 and 21 and with saline placebo at Day 182.
30
DQIV_NAS
Subjects 18-≤39 years of age (in D-QIV cohort of primary completed study FLU D-QIV-015 (201251) (A/Christchurch/16/2010 (H1N1)pdm09, A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012, B/Brisbane/60/2008)) who were administered 15 µg HA (no AS) of each of 4 strains (total 60 µg HA) at Day 0.
30
QPAN5_C
Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered 3.8 µg A/Indonesia/5/05 (H5N1) with AS03A on Day 0; phosphate buffer saline (PBS) preserved with 20 ppm thimerosal on Day 182; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Day 549.
26
QPAN5_G
Subjects 18-40 years of age (in Q-PAN cohort of primary completed study Q-PAN-005 (110624)) who were administered PBS preserved with 20 ppm thimerosal on Day 0; 3.8 µg A/turkey/Turkey/1/05 (H5N1) with AS03A on Days 182 and 549.
29
H5N1_VT
Subjects 18-60 years of age (in H5N1 cohort of primary completed study H5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received two administrations of the adjuvanted (AS03A) pandemic influenza vaccine (3.8 µg) containing the Vietnam (VT) strain at Day 0 and Month 12.
53
H5N1_IN
Subjects 18-60 years of age (in H5N1 cohort of primary completed studyH5N1-012 (107495) A/Vietnam/1194/2004-like or A/Indonesia/05/2005-like) who received one administration (3.8 µg) of the adjuvanted (AS03A) pandemic influenza vaccine containing the Vietnam (VT) strain at Day 0 and one administration (3.8 µg) of the adjuvanted (AS03A) pandemic vaccine containing the Indonesia (IN) strain at Month 12
49
H5N1_PAS
Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered adjuvanted (AS03B) pandemic vaccine with 1.9 µg HA (hemagglutinin) at Days 0 and 21.
33
H5N1_PCN
Subjects 6-35 months of age (in H5N1 cohort of primary completed study Q-PAN H5N1-AS03-021 (114464)(A/Indonesia/5/2005 RG)) who were administered placebo at Days 0 and 21.
20
Total414

Baseline characteristics

CharacteristicTotalH1N1_NASH5N1_ASH1N1_ASH5N1_NASH9N2_ASH9N2_NASDQIV_NASQPAN5_CQPAN5_GH5N1_VTH5N1_INH5N1_PASH5N1_PCN
Age, Categorical
<=18 years
53 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants33 Participants20 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
361 Participants29 Participants29 Participants29 Participants27 Participants30 Participants30 Participants30 Participants26 Participants29 Participants53 Participants49 Participants0 Participants0 Participants
Age continuous- adults subjects32.9 Years
STANDARD_DEVIATION 9.1
29.3 Years
STANDARD_DEVIATION 6.8
30.4 Years
STANDARD_DEVIATION 8.3
28.5 Years
STANDARD_DEVIATION 6.5
31.4 Years
STANDARD_DEVIATION 9.1
43.3 Years
STANDARD_DEVIATION 11.9
42.6 Years
STANDARD_DEVIATION 13.6
26.7 Years
STANDARD_DEVIATION 5.7
29.4 Years
STANDARD_DEVIATION 6.5
29.6 Years
STANDARD_DEVIATION 6.8
35.8 Years
STANDARD_DEVIATION 12.1
35.4 Years
STANDARD_DEVIATION 12.5
Age continuous-pediatric study22.9 Months
STANDARD_DEVIATION 7.3
22.6 Months
STANDARD_DEVIATION 7.6
23.5 Months
STANDARD_DEVIATION 6.9
Race/Ethnicity, Customized
American Hispanic or Latino
26 Participants1 Participants5 Participants2 Participants4 Participants2 Participants2 Participants0 Participants3 Participants4 Participants0 Participants0 Participants3 Participants0 Participants
Race/Ethnicity, Customized
Not American Hispanic or Latino
358 Participants28 Participants24 Participants27 Participants23 Participants28 Participants28 Participants0 Participants23 Participants25 Participants53 Participants49 Participants30 Participants20 Participants
Race/Ethnicity, Customized
Unknown
30 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants30 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Female
227 Participants18 Participants17 Participants19 Participants18 Participants14 Participants16 Participants22 Participants12 Participants16 Participants21 Participants28 Participants16 Participants10 Participants
Sex: Female, Male
Male
187 Participants11 Participants12 Participants10 Participants9 Participants16 Participants14 Participants8 Participants14 Participants13 Participants32 Participants21 Participants17 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 00 / 0

Outcome results

Primary

Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 CohortDay 05950.9 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 CohortDay 2111025.1 EU/mL
Primary

Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortDay 2122141.6 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 12 + 21 days14532.2 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 126743.4 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 189467.3 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortDay 05105.9 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 1810315.9 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortDay 04856.6 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortDay 2121054.9 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 127249.2 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 12 + 21 days16655.6 EU/mL
Primary

Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 04858.6 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 4221291.6 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 18210859.0 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 54910935.8 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 59115362.8 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 72911917.5 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 54912308.9 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 72910921.9 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 1824268.3 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 22420162.7 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 59114064.2 EU/mL
Primary

Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4215959.9 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1827791.5 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4228492.2 EU/mL
H1N1_NASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 38511491.9 EU/mL
H5N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4219636.8 EU/mL
H5N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1829859.5 EU/mL
Primary

Anti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 4212214.4 EU/mL
H1N1_ASAnti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 3853974.2 EU/mL
Primary

Anti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortDay 028.3 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortDay 2176.4 Titer
Primary

Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortDay 2156.9 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 1225.3 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortDay 019.0 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 12 + 21 days40.0 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 630.1 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 1832.4 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 629.3 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortDay 026.5 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortDay 21106.2 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 1832.7 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 1240.6 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 12 + 21 days74.3 Titer
Primary

Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 2130.8 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4233.0 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 011.0 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 18218.2 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 38533.0 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 018.6 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4264.5 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 18244.0 Titer
H1N1_NASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 2140.0 Titer
H5N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 030.3 Titer
H5N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 2160.6 Titer
H5N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 18258.0 Titer
H5N1_ASAnti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4291.9 Titer
Primary

Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 019.2 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 2143.5 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 4244.4 Titer
H1N1_ASAnti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 38522.4 Titer
Primary

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 CohortDay 011215.8 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 CohortDay 2130437.5 EU/mL
Primary

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortMonth 1214548.7 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortDay 2135805.4 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortMonth 12 + 21 days32675.5 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortMonth 616123.6 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortMonth 1821154.6 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortDay 09340.1 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortMonth 1819508.2 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortDay 08409.3 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortMonth 617337.3 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortMonth 1216242.1 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortMonth 12 + 21 days37096.0 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 CohortDay 2140245.6 EU/mL
Primary

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL).

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 18222057.9 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 54921272.5 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 4235325.3 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 59129023.7 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 22418748.2 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 72922445.9 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 08946.2 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 72921894.3 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 09205.1 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 4210171.2 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 18210123.1 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 22443267.9 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 54923507.6 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 CohortDay 59133113.7 EU/mL
Primary

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 06935.6 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2145098.3 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4246177.1 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 18221782.4 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 18224705.6 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4238598.2 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 06841.5 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2137969.9 EU/mL
H5N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 38525346.9 EU/mL
H5N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2146013.8 EU/mL
H5N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 014381.9 EU/mL
H5N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 18233610.2 EU/mL
H5N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4268348.8 EU/mL
H5N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4231718.0 EU/mL
H5N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2127845.9 EU/mL
H5N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 014552.3 EU/mL
H5N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 38515768.2 EU/mL
H5N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 18217401.9 EU/mL
H9N2_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 18220570.2 EU/mL
H9N2_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2125189.3 EU/mL
H9N2_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4231665.4 EU/mL
H9N2_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 012799.7 EU/mL
H9N2_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4219681.1 EU/mL
H9N2_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2116592.8 EU/mL
H9N2_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 18215471.1 EU/mL
H9N2_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 010888.1 EU/mL
Primary

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL).

Time frame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 02075.4 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 4222195.2 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 2116552.4 EU/mL
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 3858661.1 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 3852394.7 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 02123.2 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 212203.3 EU/mL
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 422272.1 EU/mL
Primary

Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: Group C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 018.5 Titer
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 4248.2 Titer
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 18240.0 Titer
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 54931.2 Titer
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 59140.0 Titer
H1N1_ASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 72949.0 Titer
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 54927.8 Titer
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 72936.1 Titer
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 18215.4 Titer
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 22451.2 Titer
H1N1_NASAnti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 59140.0 Titer
Primary

Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 CohortDay 06435.6 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 CohortDay 2112074.6 EU/mL
Primary

Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortDay 2134355.8 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 12 + 21 days48534.4 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 1214575.6 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 1823376.4 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortDay 08735.3 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 1820685.0 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortDay 08633.4 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortDay 2140833.0 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 1215958.9 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 CohortMonth 12 + 21 days51228.3 EU/mL
Primary

Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 05832.4 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 4223187.8 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 18215364.4 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 54912974.0 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 59121467.9 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 72914534.4 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 54915142.3 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 72913865.1 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 1826914.7 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 22434071.6 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 CohortDay 59124791.3 EU/mL
Primary

Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4220783.2 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 03697.2 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 18212674.3 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 38519903.0 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 08366.5 EU/mL
H1N1_NASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4251118.1 EU/mL
H5N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4236716.0 EU/mL
H5N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 18223927.1 EU/mL
H5N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 014704.5 EU/mL
Primary

Anti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)

Time frame: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 4220542.9 EU/mL
H1N1_ASAnti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 CohortDay 3857258.3 EU/mL
Primary

H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortDay 038.1 Titer
H1N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortDay 21312.2 Titer
Primary

H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortDay 011.9 Titer
H1N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortDay 2122.8 Titer
H1N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 12 + 21 days21.2 Titer
H1N1_NASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortDay 013.7 Titer
H1N1_NASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortDay 2127.0 Titer
H1N1_NASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 12 + 21 days23.2 Titer
Primary

H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 017.5 Titer
H1N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42186.6 Titer
H1N1_NASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 025.5 Titer
H1N1_NASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4252.5 Titer
H5N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 041.0 Titer
H5N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4260.6 Titer
Primary

H1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 040.9 Titer
H1N1_ASH1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 4256.6 Titer
Primary

H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASH1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 4219.0 Titer
H1N1_ASH1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 012.4 Titer
H1N1_ASH1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 59133.6 Titer
H1N1_ASH1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 54922.3 Titer
H1N1_NASH1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 59131.4 Titer
H1N1_NASH1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 18212.4 Titer
H1N1_NASH1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 22424.4 Titer
H1N1_NASH1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 54926.9 Titer
Primary

H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortDay 028.3 Titer
H1N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortDay 21118.9 Titer
Primary

H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortDay 020.0 Titer
H1N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortDay 2175.9 Titer
H1N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 12 + 21 Days73.4 Titer
H1N1_NASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortDay 018.4 Titer
H1N1_NASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortDay 2194.1 Titer
H1N1_NASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 12 + 21 Days72.2 Titer
Primary

H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 015.6 Titer
H1N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42338.2 Titer
H1N1_NASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 024.6 Titer
H1N1_NASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4278.1 Titer
H5N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 024.8 Titer
H5N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4287.7 Titer
Primary

H1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 018.8 Titer
H1N1_ASH1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 4262.2 Titer
Primary

H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASH1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 020.5 Titer
H1N1_ASH1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 4268.2 Titer
H1N1_ASH1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 54942.3 Titer
H1N1_ASH1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 59184.8 Titer
H1N1_NASH1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 59177.3 Titer
H1N1_NASH1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 54947.2 Titer
H1N1_NASH1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 18219.1 Titer
H1N1_NASH1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 22478.0 Titer
Primary

Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At D21 (post-dose1) compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort1.9 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortDay 214.3 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 121.4 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 12 + 21 days3.0 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 181.9 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 182.3 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortDay 214.3 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 12 + 21 days3.5 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 121.5 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 424.4 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5492.2 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5913.0 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 7292.3 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 7292.2 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 2244.5 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5912.8 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5492.5 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 425.3 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1822.5 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 424.9 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 3852.0 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 422.8 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1821.4 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385(post-vaccination2/ Day 0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortDay 4215.9 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortDay 3854.7 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5912.1 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5491.7 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 7292.6 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 422.6 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 1822.2 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 7292.3 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 2243.3 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5491.8 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5912.5 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At D21 (post-dose1) compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort2.7 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 61.6 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 12 + 21 days2.1 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 121.3 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 181.7 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortDay 213.0 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 181.3 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortDay 214.0 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 61.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 121.5 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 12 + 21 days2.9 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 423.0 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 212.8 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 1821.7 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 3851.8 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 212.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 423.5 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 1822.4 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 212.0 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 1822.0 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 423.0 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS VaccinesDay 212.3 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS VaccinesDay 422.3 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS VaccinesDay 3851.1 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At D21 (post-dose1) compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort2.7 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 61.7 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 12 + 21 days3.6 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 121.6 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 182.3 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortDay 213.8 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 182.5 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortDay 214.8 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 62.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 121.9 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 12 + 21 days4.5 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5913.1 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 1822.5 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 7292.4 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 423.9 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5492.3 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 2242.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 7291.9 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 2244.0 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5492.0 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5912.9 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 427.0 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1823.2 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 216.5 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 425.6 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 215.9 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1823.6 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 213.2 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 3851.8 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 424.8 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1822.3 Ratio
H5N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 3851.1 Ratio
H5N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 211.9 Ratio
H5N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 422.2 Ratio
H5N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1821.2 Ratio
H9N2_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 422.5 Ratio
H9N2_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 212.0 Ratio
H9N2_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1821.6 Ratio
H9N2_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1821.4 Ratio
H9N2_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 211.5 Ratio
H9N2_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 421.8 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortDay 4211.3 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortDay 218.8 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortDay 3854.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortDay 211.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortDay 421.0 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortDay 3851.4 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At D21 (post-dose1) compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort1.9 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortDay 213.9 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 121.7 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 12 + 21 days5.6 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 182.6 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 182.5 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortDay 214.7 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 12 + 21 days6.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 CohortMonth 121.8 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 424.0 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5492.2 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5913.6 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 7294.7 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 7291.8 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 2244.7 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5913.3 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5492.0 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 426.0 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1823.5 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 426.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 3852.4 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 422.5 Ratio
H5N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 1821.8 Ratio
Primary

Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.

Time frame: At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385[post-vaccination2]/ Day 0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortDay 4217.1 Ratio
H1N1_ASMean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 CohortDay 3855.5 Ratio
Primary

Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 421.5 Ratio
H1N1_ASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5491.8 Ratio
H1N1_ASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5912.6 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 2241.9 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5492.0 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5912.2 Ratio
Primary

Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At D21 (post-dose1) compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort8.2 Ratio
Primary

Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortDay 211.9 Ratio
H1N1_ASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 121.2 Ratio
H1N1_ASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 12 + 21 days1.8 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortDay 212.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 121.3 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 12 + 21 days1.7 Ratio
Primary

Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day 42 (post-vaccination2/ pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)9.9 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)1.9 Ratio
H5N1_ASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)1.4 Ratio
Primary

Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day 42 (post-vaccination2/ pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)1.3 Ratio
Primary

Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 423.3 Ratio
H1N1_ASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5492.1 Ratio
H1N1_ASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5914.0 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 2244.0 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5492.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5913.6 Ratio
Primary

Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At D21 (post-dose1) compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort4.3 Ratio
Primary

Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortDay 213.8 Ratio
H1N1_ASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 121.3 Ratio
H1N1_ASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 12 + 21 Days3.4 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortDay 215.2 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 121.9 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 12 + 21 Days4.2 Ratio
Primary

Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day 42 (post-vaccination2/ pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)21.4 Ratio
H1N1_NASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)3.0 Ratio
H5N1_ASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)3.4 Ratio
Primary

Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day 42 (post-vaccination2/ pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines3.3 Ratio
Primary

Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5491.4 Ratio
H1N1_ASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 421.7 Ratio
H1N1_ASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5917.8 Ratio
H1N1_NASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 2242.6 Ratio
H1N1_NASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5491.3 Ratio
H1N1_NASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 CohortDay 5914.0 Ratio
Primary

Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At D21 (post-dose1 compared to D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort1.2 Ratio
Primary

Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortDay 212.0 Ratio
H1N1_ASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 121.5 Ratio
H1N1_ASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 12 + 21 days7.1 Ratio
H1N1_NASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortDay 212.4 Ratio
H1N1_NASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 121.4 Ratio
H1N1_NASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 CohortMonth 12 + 21 days13.8 Ratio
Primary

Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day 42 (post-vaccination2/ pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)3.2 Ratio
H1N1_NASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)3.3 Ratio
H5N1_ASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)2.4 Ratio
Primary

Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.

Time frame: At Day 42 (post-vaccination2/ pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (GEOMETRIC_MEAN)
H1N1_ASMean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)3.4 Ratio
Primary

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.

Time frame: At D21 (post-dose1 compared to [/]D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult FLU D-QIV-015 Cohort10.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Time frame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 CohortDay 219.4 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 CohortMonth 12 + 21 days4.2 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 CohortDay 2112.2 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 CohortMonth 12 + 21 days6.4 Percentage of subjects
Primary

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer. The ≥10-fold increases were only calculated relative to baseline.

Time frame: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 CohortDay 427.7 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 CohortDay 5910.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 CohortDay 2247.1 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 CohortDay 5910.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.

Time frame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 216.9 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 426.9 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 216.9 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 426.9 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 216.7 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 426.7 Percentage of subjects
Primary

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.

Time frame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 216.1 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 423.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.

Time frame: At D21 (post-dose1 compared to [/]D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort3.3 Percentage of subjects
Primary

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration. The ≥10-fold increases were only calculated relative to baseline.

Time frame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 CohortDay 2115.1 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 CohortMonth 12 + 21 days14.6 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 CohortDay 2118.4 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 CohortMonth 12 + 21 days21.3 Percentage of subjects
Primary

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration. The ≥10-fold increases were only calculated relative to baseline.

Time frame: For group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 4223.1 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 2240.0 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 5914.2 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 22425.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 5915.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.

Time frame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2129.6 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4236.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2134.8 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4228.0 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 216.9 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4220.7 Percentage of subjects
H5N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 213.7 Percentage of subjects
H5N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 427.4 Percentage of subjects
H9N2_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 210.0 Percentage of subjects
H9N2_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 420.0 Percentage of subjects
H9N2_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 210.0 Percentage of subjects
H9N2_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 420.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.

Time frame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortDay 2140.6 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortDay 4253.1 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortDay 210.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortDay 420.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At D21 (post-dose1 compared to [/]D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort13.3 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Time frame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 CohortDay 2137.7 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 CohortMonth 12 + 21 days31.3 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 CohortDay 2146.9 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 CohortMonth 12 + 21 days34.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Time frame: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 4246.2 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 59137.5 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 22446.4 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 59140.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts48.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts51.7 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts30.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohortand for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At Day 42 (post-vaccination2 compared to Day 0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort81.8 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At D21 (post-dose1 compared to [/]D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult FLU D-QIV-015 Cohort53.3 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Time frame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 CohortDay 2149.1 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 CohortMonth 12 + 21 days31.3 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 CohortDay 2167.3 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 CohortMonth 12 + 21 days51.1 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Time frame: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 CohortDay 4242.3 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 CohortDay 59125.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 CohortDay 22457.1 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 CohortDay 59145.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 2144.8 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4251.7 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 2127.6 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4265.5 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 2123.3 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4246.7 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 2139.4 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 4239.4 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At D21 (post-dose1 compared to [/]D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort33.3 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Time frame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 CohortDay 2139.6 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 CohortMonth 12 + 21 days39.6 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 CohortDay 2155.1 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 CohortMonth 12 + 21 days46.8 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Time frame: For group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182); at Day 591 (post-dose3 / Day 182)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 4250.0 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 22415.4 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 59129.2 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 22446.4 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 59150.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. Seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At Day 21 (post-vaccination 1 compared to pre-vaccination), Day 42 (post-vaccination 2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2163.0 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4272.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2152.2 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4260.0 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2134.5 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4255.2 Percentage of subjects
H5N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 217.4 Percentage of subjects
H5N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4218.5 Percentage of subjects
H9N2_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 2110.0 Percentage of subjects
H9N2_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 4220.0 Percentage of subjects
H9N2_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 216.7 Percentage of subjects
H9N2_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 423.3 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortDay 2159.4 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortDay 4271.9 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortDay 210.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 CohortDay 420.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At D21 (post-dose1 compared to [/]D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort6.7 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Time frame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 CohortDay 2141.5 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 CohortMonth 12 + 21 days56.3 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 CohortDay 2151.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 CohortMonth 12 + 21 days61.7 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.

Time frame: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 4250.0 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 59145.8 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 22446.4 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 CohortDay 59155.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts72.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts62.1 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts20.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohortand for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration \< 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At Day 42 (post-vaccination2 compared to Day 0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort96.6 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At D21 (post-dose1 compared to [/]D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort77.8 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Time frame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 CohortDay 2118.9 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 CohortMonth 12 + 21 days22.9 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 CohortDay 2126.7 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 CohortMonth 12 + 21 days21.7 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Time frame: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 CohortDay 4215.4 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 CohortDay 59125.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 CohortDay 22425.0 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 CohortDay 59135.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)84.6 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)42.1 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)6.9 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)3.3 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At D21 (post-dose1 compared to [/]D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort57.1 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Time frame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 CohortDay 2164.2 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 CohortMonth 12 + 21 Days52.1 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 CohortDay 2170.2 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 CohortMonth 12 + 21 Days55.3 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Time frame: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 CohortDay 4265.4 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 CohortDay 59162.5 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 CohortDay 22457.1 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 CohortDay 59150.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)95.8 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)55.6 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)55.2 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer

Time frame: At Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)51.5 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At D21 (post-dose1 compared to [/]D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult FLU D-QIV-015 Cohort0.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Time frame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 CohortDay 2134.0 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 CohortMonth 12 + 21 days77.1 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 CohortDay 2130.6 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 CohortMonth 12 + 21 days91.5 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.

Time frame: For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 CohortDay 4226.9 Percentage of subjects
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 CohortDay 59183.3 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 CohortDay 22442.9 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 CohortDay 59155.0 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)55.2 Percentage of subjects
H1N1_NASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)51.7 Percentage of subjects
H5N1_ASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)43.3 Percentage of subjects
Primary

Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer \< 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.

Time frame: At Day 42 (post-vaccination2 compared to pre-vaccination)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (NUMBER)
H1N1_ASPercentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)54.5 Percentage of subjects
Primary

Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 CohortDay 21100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 12 + 21 days100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 12100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 18100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 18100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 12100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 12 + 21 days100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Time frame: At D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 182100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 729100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 729100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 182100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 224100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Time frame: At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 182100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 385100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 182100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Time frame: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 385100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortDay 21100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Time frame: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 6100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 12100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 12 + 21 days100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 18100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 12 + 21 days100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 12100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 1897.8 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 6100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Time frame: Group C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 182100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 729100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 729100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 182100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 224100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by microneutralization (MN) for all subjects who received an adjuvant system (AS) vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution (1/DIL).

Time frame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 182100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 21100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 385100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 182100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 21100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 182100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 0100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.

Time frame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 385100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult FLU D-QIV-015 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult FLU D-QIV-015 CohortDay 21100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortMonth 6100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortMonth 12100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortMonth 12 + 21 days100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortMonth 18100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortMonth 12 + 21 days100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortMonth 12100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortMonth 18100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 CohortMonth 6100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL).

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 182100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 224100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 729100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 729100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 42100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 182100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 224100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from Hemagglutinin (HA) Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL).

Time frame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 182100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 21100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 182100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 21100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 0100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 182100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 385100 Percentage of subjects
H5N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 0100 Percentage of subjects
H5N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H5N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 385100 Percentage of subjects
H5N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 182100 Percentage of subjects
H5N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 21100 Percentage of subjects
H9N2_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 182100 Percentage of subjects
H9N2_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 0100 Percentage of subjects
H9N2_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H9N2_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 21100 Percentage of subjects
H9N2_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H9N2_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 0100 Percentage of subjects
H9N2_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 21100 Percentage of subjects
H9N2_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 182100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)

Time frame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 385100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 385100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 42100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 21100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 CohortDay 21100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Time frame: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 12 + 21 days100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 12100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 18100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 18100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 12100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 CohortMonth 12 + 21 days100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Time frame: At D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 182100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 729100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 729100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 182100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 224100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Time frame: At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 182100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 385100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 42100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 182100 Percentage of subjects
H5N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsDay 0100 Percentage of subjects
Primary

Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)

Time frame: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 CohortDay 385100 Percentage of subjects
Primary

Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortDay 096.6 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortDay 21100 Percentage of subjects
Primary

Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Time frame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 096.2 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 12 + 21 days97.9 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 097.9 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 12 + 21 days97.9 Percentage of subjects
Primary

Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

Time frame: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 092.3 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 4296.2 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 54996.0 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 18289.7 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 22496.4 Percentage of subjects
Primary

Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution).

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
H5N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 0100 Percentage of subjects
H5N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
Primary

Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 42100 Percentage of subjects
Primary

Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortDay 096.7 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortDay 21100 Percentage of subjects
Primary

Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

Time frame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 12 + 21 Days100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 098.0 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 2197.9 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 12 + 21 Days100 Percentage of subjects
Primary

Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

Time frame: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 182100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 224100 Percentage of subjects
Primary

Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution ).

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 096.3 Percentage of subjects
H1N1_NASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4293.1 Percentage of subjects
H5N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 096.6 Percentage of subjects
H5N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
Primary

Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 42100 Percentage of subjects
Primary

Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 CohortDay 21100 Percentage of subjects
Primary

Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Time frame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 12 + 21 days100 Percentage of subjects
H1N1_NASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortDay 21100 Percentage of subjects
H1N1_NASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 CohortMonth 12 + 21 days100 Percentage of subjects
Primary

Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL

Time frame: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 0100 Percentage of subjects
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
H1N1_NASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 591100 Percentage of subjects
H1N1_NASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 549100 Percentage of subjects
H1N1_NASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 182100 Percentage of subjects
H1N1_NASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 CohortDay 224100 Percentage of subjects
Primary

Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution )

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 0100 Percentage of subjects
H1N1_NASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
H5N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 0100 Percentage of subjects
H5N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 42100 Percentage of subjects
Primary

Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 097.0 Percentage of subjects
H1N1_ASPercentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 42100 Percentage of subjects
Primary

RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At D0 (Pre), D21 (Post-dose 1)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortDay 018.7 Titer
H1N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 CohortDay 2122.4 Titer
Primary

RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 CohortDay 020.0 Titer
H1N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 CohortDay 2140.5 Titer
H1N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 12 + 21 days146.7 Titer
H1N1_NASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 CohortDay 018.9 Titer
H1N1_NASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 CohortDay 2144.8 Titer
H1N1_NASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 CohortMonth 12 + 21 days256.5 Titer
Primary

RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 014.3 Titer
H1N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4246.2 Titer
H1N1_NASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 023.6 Titer
H1N1_NASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4278.1 Titer
H5N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 030.3 Titer
H5N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)Day 4272.9 Titer
Primary

RG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 014.3 Titer
H1N1_ASRG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)Day 4248.3 Titer
Primary

RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort

With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.

Time frame: Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASRG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 020.0 Titer
H1N1_ASRG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 4234.1 Titer
H1N1_ASRG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 54927.1 Titer
H1N1_ASRG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 591155.4 Titer
H1N1_NASRG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 59182.8 Titer
H1N1_NASRG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 54927.8 Titer
H1N1_NASRG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 18219.5 Titer
H1N1_NASRG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 CohortDay 22451.2 Titer
Secondary

GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 Cohort

With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).

Time frame: At D21, D42, D182 and Day 385

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 CohortDay 2146013.8 EU/mL
H1N1_ASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 CohortDay 4268348.8 EU/mL
H1N1_ASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 CohortDay 18233610.2 EU/mL
H1N1_ASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 CohortDay 38525346.9 EU/mL
H1N1_NASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 CohortDay 38515768.2 EU/mL
H1N1_NASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 CohortDay 2127845.9 EU/mL
H1N1_NASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 CohortDay 18217401.9 EU/mL
H1N1_NASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 CohortDay 4231718.0 EU/mL
95% CI: [1.12, 2.47]ANCOVA
95% CI: [1.54, 3.03]ANCOVA
95% CI: [1.49, 2.54]ANCOVA
95% CI: [1.32, 2.01]ANCOVA
Secondary

GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 Cohort

With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).

Time frame: At D21, D42, and D182

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 CohortDay 2145098.3 EU/mL
H1N1_ASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 CohortDay 4246177.1 EU/mL
H1N1_ASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 CohortDay 18221782.4 EU/mL
H1N1_NASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 CohortDay 2137969.9 EU/mL
H1N1_NASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 CohortDay 4238598.2 EU/mL
H1N1_NASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 CohortDay 18224705.6 EU/mL
95% CI: [0.73, 1.72]ANCOVA
95% CI: [0.83, 1.81]ANCOVA
95% CI: [0.63, 1.24]ANCOVA
Secondary

GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 Cohort

With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).

Time frame: At D21, D42 and D182

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
H1N1_ASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 CohortDay 2125189.3 EU/mL
H1N1_ASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 CohortDay 4231665.4 EU/mL
H1N1_ASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 CohortDay 18220570.2 EU/mL
H1N1_NASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 CohortDay 2116592.8 EU/mL
H1N1_NASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 CohortDay 4219681.1 EU/mL
H1N1_NASGMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 CohortDay 18215471.1 EU/mL
95% CI: [1.14, 1.69]ANCOVA
95% CI: [1.28, 1.73]ANCOVA
95% CI: [1, 1.44]ANCOVA
Secondary

Number of Subjects With Seropositivity Status Against Flu A/Indonesia/05/2005 (H5N1) HI Antibodies - Pediatric H5N1 Cohort

With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status against Flu A/Indonesia/05/2005 (H5N1) HI antibodies - Pediatric H5N1 cohort. Seronegative subjects = Subjects with antibody titer \< 10 1/DIL for Flu A/Ind/05/05 (H5N1).HA HI prior to vaccination and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Flu A/Ind/05/05 (H5N1).HA HI prior to vaccination.

Time frame: At Day 0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
H1N1_ASNumber of Subjects With Seropositivity Status Against Flu A/Indonesia/05/2005 (H5N1) HI Antibodies - Pediatric H5N1 Cohort33 Participants
Secondary

Number of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts

With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at baseline (Day 0) for the HI assay against the pandemic vaccine homologous virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 cohorts. Seronegative subjects = Subjects with antibody titer \< 10 1/DIL for Pandemic vaccine homologous virus and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Pandemic vaccine homologous virus (i.e., A/California/7/2009 for subjects from the Q-PAN H1N1-019 study, A/Indonesia/5/2005 for subjects from CC-PAN H5N1-001 study, A/chicken/Hong Kong/G9/1997 for subjects from Q-PAN H9N2-001 study).

Time frame: At Day 0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
H1N1_ASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeronegative17 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeropositive12 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeronegative19 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeropositive10 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeronegative20 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeropositive9 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeronegative26 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeropositive1 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeronegative19 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeropositive11 Participants
H9N2_NASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeronegative18 Participants
H9N2_NASNumber of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 CohortsSeropositive12 Participants
Secondary

Number of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 Cohorts

With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at pre-vaccination (Baseline) for the HI assay against A/California/7/09 virus (or like virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 cohorts. Seronegative subjects = Subjects with antibody titer \< 10 1/DIL for A/California/7/09 virus (or like virus) and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for A/California/7/09 virus (or like virus).

Time frame: At Day 0

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeronegative17 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsMissing0 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeropositive12 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeropositive10 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsMissing0 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeronegative19 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsMissing1 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeronegative7 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeropositive21 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsMissing0 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeronegative9 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeropositive18 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeronegative4 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeropositive26 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsMissing0 Participants
H9N2_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeropositive23 Participants
H9N2_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeronegative7 Participants
H9N2_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsMissing0 Participants
QPAN5_CNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeronegative16 Participants
QPAN5_CNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsMissing0 Participants
QPAN5_CNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeropositive10 Participants
QPAN5_GNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeropositive14 Participants
QPAN5_GNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeronegative15 Participants
QPAN5_GNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsMissing0 Participants
H5N1_VTNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeropositive19 Participants
H5N1_VTNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeronegative31 Participants
H5N1_VTNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsMissing3 Participants
H5N1_INNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeronegative32 Participants
H5N1_INNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsMissing2 Participants
H5N1_INNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 CohortsSeropositive15 Participants
Secondary

Number of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 Cohorts

With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at baseline (at Day 0 in all subjects except for group G of Q-PAN-005 \[i.e, at Day182\]) for the HI assay against the pandemic vaccine homologous virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 cohorts . Seronegative subjects = Subjects with antibody titer \< 10 1/DIL for Pandemic vaccine homologous virus and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Pandemic vaccine homologous virus (i.e., for FLU D-QIV-015: A/Christchurch/16/2010 at Day 0, for Q-PAN-005 study, group C: A/Turkey/01/2005 and A/Indonesia/5/2005 at Day 0 and for group G, A/Turkey/01/2005 at Day 182, for H5N1-012 study, for group VT/VT/12M : A/Vietnam/1194/2004 at Day 0, for group VT/IN/12M, A/Indonesia/5/2005 and A/Vietnam/1194/2004-like at Day 0).

Time frame: At Day 0, (except for group G of Q-PAN-005, at Day182)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-seropositive0 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-seropositive0 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-seronegative3 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-seronegative0 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-missing30 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-missing30 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-seronegative0 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-missing0 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-seropositive0 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-seronegative0 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-seropositive27 Participants
H1N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-missing30 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-missing26 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-missing0 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-seropositive0 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-seronegative25 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-seronegative0 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-seropositive0 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-missing26 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-seropositive1 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-seronegative0 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-seronegative26 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-missing0 Participants
H1N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-seropositive0 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-seropositive0 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-seronegative0 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-seropositive0 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-missing29 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-seronegative0 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-seropositive0 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-missing29 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-seronegative24 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-seropositive5 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-missing0 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-seronegative0 Participants
H5N1_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-missing29 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-missing53 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-seronegative0 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-seropositive0 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-seropositive0 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-missing53 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-seronegative0 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-missing0 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-seronegative52 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-missing53 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-seropositive0 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-seropositive1 Participants
H5N1_NASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-seronegative0 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-missing0 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-seronegative49 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-seronegative0 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-seropositive0 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-seropositive0 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-seronegative49 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-missing0 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Indonesia/5/2005-seropositive0 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-missing49 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Turkey/01/2005-seronegative0 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Christchurch/16/2010-missing49 Participants
H9N2_ASNumber of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 CohortsA/Vietnam/1194/2004-like-seropositive0 Participants
Secondary

Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 Cohort

With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At D21, D42, D182 and Day 385 (compared to Day 0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 CohortDay 2134.5 Percentage of subjects
H1N1_ASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 CohortDay 4255.2 Percentage of subjects
H1N1_ASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 CohortDay 18213.8 Percentage of subjects
H1N1_ASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 CohortDay 3856.9 Percentage of subjects
H1N1_NASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 CohortDay 3850.0 Percentage of subjects
H1N1_NASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 CohortDay 217.4 Percentage of subjects
H1N1_NASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 CohortDay 1827.4 Percentage of subjects
H1N1_NASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 CohortDay 4218.5 Percentage of subjects
95% CI: [5.96, 47.01]Asymptotic standardized 95% CI
95% CI: [11.41, 57.53]Asymptotic standardized 95% CI
95% CI: [-11.91, 24.71]Asymptotic standardized 95% CI
95% CI: [-6.19, 22.15]Asymptotic standardized 95% CI
Secondary

Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 Cohort

With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At D21, D42, and D182 (compared to Day 0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 CohortDay 2163.0 Percentage of subjects
H1N1_ASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 CohortDay 4272.0 Percentage of subjects
H1N1_ASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 CohortDay 18225.9 Percentage of subjects
H1N1_NASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 CohortDay 18232.0 Percentage of subjects
H1N1_NASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 CohortDay 2152.2 Percentage of subjects
H1N1_NASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 CohortDay 4260.0 Percentage of subjects
95% CI: [-16.5, 36.83]Asymptotic standardized 95% CI
95% CI: [-14.45, 36.98]Asymptotic standardized 95% CI
95% CI: [-30.56, 18.65]Asymptotic standardized 95% CI
Secondary

Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 Cohort

With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point. seronegative subjects = concentration \< 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.

Time frame: At D21, D42 and D182 (compared to Day 0)

Population: All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.

ArmMeasureGroupValue (NUMBER)
H1N1_ASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 CohortDay 2110.0 Percentage of subjects
H1N1_ASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 CohortDay 4220.0 Percentage of subjects
H1N1_ASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 CohortDay 1823.6 Percentage of subjects
H1N1_NASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 CohortDay 216.7 Percentage of subjects
H1N1_NASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 CohortDay 423.3 Percentage of subjects
H1N1_NASPercentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 CohortDay 1823.3 Percentage of subjects
95% CI: [-13.06, 20.24]Asymptotic standardized 95% CI
95% CI: [0.35, 34.76]Asymptotic standardized 95% CI
95% CI: [-13.76, 15]Asymptotic standardized 95% CI

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026