Clinical trial NCT02415842: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunologic Tests
Keywords: Supra-seasonal influenza vaccine
Pandemic
Exploratory
Protein epitopes
Laboratory evaluation
Retrospective
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2015-04-14
Enrollment: 414
Sex: ALL
Minimum age (years): 6
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Archived serum samples to be evaluated in this study were collected from adults 18-64 years of age and children 6-35 months of age.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 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)
measure: Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
timeFrame: 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)
measure: 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
timeFrame: At Day 21 (post-vaccination 1 compared to pre-vaccination), Day 42 (post-vaccination 2 compared to pre-vaccination)
measure: 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
timeFrame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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
timeFrame: 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 )
measure: 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
timeFrame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
measure: Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
timeFrame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
timeFrame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
measure: Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
timeFrame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
measure: Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort
timeFrame: At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)
measure: 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
timeFrame: 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)
measure: Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
timeFrame: 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
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
measure: Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
measure: Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
measure: Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0)
measure: Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0)
measure: Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1) compared to D0
measure: 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)
timeFrame: 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)
measure: Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
timeFrame: 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)
measure: 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)
timeFrame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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)
timeFrame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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)
timeFrame: 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 )
measure: 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)
timeFrame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
measure: Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
timeFrame: At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)
measure: 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)
timeFrame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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)
timeFrame: At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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
timeFrame: At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)
measure: 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
timeFrame: 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)
measure: Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
timeFrame: 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
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
measure: Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
measure: Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
measure: Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Anti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0)
measure: Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0)
measure: Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1) compared to D0
measure: 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
timeFrame: 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)
measure: Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
timeFrame: 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)
measure: 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
timeFrame: At Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
measure: Anti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
timeFrame: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
timeFrame: At Day 42 (post-vaccination2 compared to Day 0)
measure: 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
timeFrame: At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385[post-vaccination2]/ Day 0)
measure: 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
timeFrame: 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
measure: Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
timeFrame: 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
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
timeFrame: 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
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
measure: Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
measure: Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0)
measure: 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
timeFrame: At D21 (post-dose1) compared to D0
measure: 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
timeFrame: 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)
measure: Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
timeFrame: 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)
measure: 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
timeFrame: At Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
measure: Anti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
timeFrame: At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
timeFrame: At Day 42 (post-vaccination2 compared to Day 0)
measure: 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
timeFrame: At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385(post-vaccination2/ Day 0)
measure: 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
timeFrame: 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
measure: Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
timeFrame: 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
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
timeFrame: 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
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
measure: Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
measure: Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0)
measure: 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
timeFrame: At D21 (post-dose1) compared to D0
measure: 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)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: 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)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: 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)
timeFrame: At Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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)
timeFrame: At Day 42 (post-vaccination2/ pre-vaccination)
measure: 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)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: RG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: 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)
timeFrame: At Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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)
timeFrame: At Day 42 (post-vaccination2/ pre-vaccination)
measure: 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
timeFrame: 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)
measure: RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
timeFrame: 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
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
measure: RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
measure: Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
measure: Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0)
measure: 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
timeFrame: At D21 (post-dose1 compared to D0)
measure: 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)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: 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)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: 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)
timeFrame: At Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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)
timeFrame: At Day 42 (post-vaccination2/ pre-vaccination)
measure: 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)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: H1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: 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)
timeFrame: At Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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
timeFrame: At Day 42 (post-vaccination2/ pre-vaccination)
measure: 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
timeFrame: 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)
measure: H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
timeFrame: 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
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
measure: H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
measure: Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
measure: Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0)
measure: 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
timeFrame: At D21 (post-dose1) compared to D0
measure: 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)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: 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)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: 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)
timeFrame: At Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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)
timeFrame: At Day 42 (post-vaccination2/ pre-vaccination)
measure: 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)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: H1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
timeFrame: At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)
measure: 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)
timeFrame: At Day 42 (post-vaccination2 compared to pre-vaccination)
measure: 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)
timeFrame: At Day 42 (post-vaccination2/ pre-vaccination)
measure: 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
timeFrame: 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)
measure: H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort
timeFrame: 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)
measure: Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
timeFrame: 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
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
measure: H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)
measure: Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)
measure: Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
timeFrame: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0
measure: 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
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
timeFrame: At D0 (Pre), D21 (Post-dose 1)
measure: Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort
timeFrame: At D21 (post-dose1 compared to [/]D0)
measure: 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
timeFrame: At D21 (post-dose1) compared to D0
Secondary outcomes:
measure: GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 Cohort
timeFrame: At D21, D42, and D182
measure: GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 Cohort
timeFrame: At D21, D42, D182 and Day 385
measure: GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 Cohort
timeFrame: At D21, D42 and D182
measure: Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 Cohort
timeFrame: At D21, D42, and D182 (compared to Day 0)
measure: Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 Cohort
timeFrame: At D21, D42, D182 and Day 385 (compared to Day 0)
measure: Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 Cohort
timeFrame: At D21, D42 and D182 (compared to Day 0)
measure: 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
timeFrame: At Day 0
measure: 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
timeFrame: At Day 0, (except for group G of Q-PAN-005, at Day182)
measure: 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
timeFrame: At Day 0
measure: Number of Subjects With Seropositivity Status Against Flu A/Indonesia/05/2005 (H5N1) HI Antibodies - Pediatric H5N1 Cohort
timeFrame: At Day 0
Other outcomes:
Locations:
city: New York
country: United States
facility: GSK Investigational Site
state: New York
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Nachbagauer R, Salaun B, Stadlbauer D, Behzadi MA, Friel D, Rajabhathor A, Choi A, Albrecht RA, Debois M, Garcia-Sastre A, Rouxel RN, Sun W, Palese P, Mallett CP, Innis BL, Krammer F, Claeys C. Pandemic influenza virus vaccines boost hemagglutinin stalk-specific antibody responses in primed adult and pediatric cohorts. NPJ Vaccines. 2019 Dec 6;4:51. doi: 10.1038/s41541-019-0147-z. eCollection 2019.