N/A
Completed N=414
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
Immunologic Tests
Source: ClinicalTrials.gov NCT02415842 ↗
Enrolled (actual)
414
Serious AEs
—
Results posted
Jun 2019
Primary outcomePrimary: 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 — 100; 100; 100; 100 Percentage of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
100; 100; 100; 100; 100; 100 | — |
| 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 |
6935.6; 6841.5; 14381.9; 14552.3; 12799.7; 10888.1 | — |
| 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 |
63.0; 52.2; 34.5; 7.4; 10.0; 6.7 | — |
| 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 |
29.6; 34.8; 6.9; 3.7; 0.0; 0.0 | — |
| 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 |
6.5; 5.9; 3.2; 1.9; 2.0; 1.5 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort |
2075.4; 2123.2; 16552.4; 2203.3; 22195.2; 2272.1 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort |
59.4; 0.0; 71.9; 0.0 | — |
| PRIMARY Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort |
40.6; 0.0; 53.1; 0.0 | — |
| 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 |
8.8; 1.1; 11.3; 1.0; 4.1; 1.4 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort |
8946.2; 9205.1; 35325.3; 10171.2; 22057.9; 10123.1 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort |
50.0; 15.4; 46.4; 29.2; 50.0 | — |
| PRIMARY Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort |
23.1; 0.0; 25.0; 4.2; 5.0 | — |
| PRIMARY Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort |
3.9; 2.5; 2.1; 4.0; 2.3; 2.0 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort |
9340.1; 8409.3; 35805.4; 40245.6; 16123.6; 17337.3 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort |
39.6; 55.1; 39.6; 46.8 | — |
| PRIMARY Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort |
15.1; 18.4; 14.6; 21.3 | — |
| PRIMARY Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort |
3.8; 4.8; 1.7; 2.1; 1.6; 1.9 | — |
| 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 |
100; 100 | — |
| PRIMARY Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 Cohort |
11215.8; 30437.5 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort |
33.3 | — |
| PRIMARY Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort |
3.3 | — |
| PRIMARY Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort |
2.7 | — |
| 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) |
100; 100; 100; 100; 100; 100 | — |
| 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) |
11.0; 18.6; 30.3; 30.8; 40.0; 60.6 | — |
| 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) |
44.8; 27.6; 23.3; 51.7; 65.5; 46.7 | — |
| 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) |
6.9; 6.9; 6.7; 6.9; 6.9; 6.7 | — |
| 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) |
2.8; 2.1; 2.0; 3.0; 3.5; 3.0 | — |
| 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) |
100; 100; 100; 100 | — |
| PRIMARY Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines) |
19.2; 43.5; 44.4; 22.4 | — |
| 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) |
39.4; 39.4 | — |
| 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) |
6.1; 3.0 | — |
| 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 |
2.3; 2.3; 1.1 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort |
18.5; 48.2; 40.0; 15.4; 51.2; 31.2 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort |
42.3; 57.1; 25.0; 45.0 | — |
| PRIMARY Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort |
7.7; 7.1; 0.0; 0.0 | — |
| PRIMARY Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort |
2.6; 2.2; 3.3; 1.7; 1.8; 2.1 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort |
19.0; 26.5; 56.9; 106.2; 30.1; 29.3 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 Cohort |
49.1; 67.3; 31.3; 51.1 | — |
| PRIMARY Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 Cohort |
9.4; 12.2; 4.2; 6.4 | — |
| PRIMARY Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort |
3.0; 4.0; 1.6; 1.1; 1.3; 1.5 | — |
| 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 |
100; 100 | — |
| PRIMARY Anti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort |
28.3; 76.4 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult FLU D-QIV-015 Cohort |
53.3 | — |
| PRIMARY Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult FLU D-QIV-015 Cohort |
10.0 | — |
| 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 |
2.7 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts |
3697.2; 8366.5; 14704.5; 20783.2; 51118.1; 36716.0 | — |
| 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 |
72.0; 62.1; 20.0 | — |
| 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 |
6.0; 6.1; 2.5; 3.5; 1.8; 2.4 | — |
| 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 |
100; 100 | — |
| PRIMARY Anti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort |
20542.9; 7258.3 | — |
| 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 |
96.6 | — |
| 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 |
17.1; 5.5 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort |
5832.4; 23187.8; 15364.4; 6914.7; 34071.6; 12974.0 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort |
50.0; 46.4; 45.8; 55.0 | — |
| 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 |
4.0; 4.7; 2.2; 2.0; 3.6; 3.3 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort |
8735.3; 8633.4; 34355.8; 40833.0; 14575.6; 15958.9 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort |
41.5; 51.0; 56.3; 61.7 | — |
| PRIMARY Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort |
3.9; 4.7; 1.7; 1.8; 5.6; 6.1 | — |
| 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 |
100; 100 | — |
| PRIMARY Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort |
6435.6; 12074.6 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort |
6.7 | — |
| 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 |
1.9 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts |
15959.9; 28492.2; 19636.8; 7791.5; 9859.5; 11491.9 | — |
| 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 |
48.0; 51.7; 30.0 | — |
| 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 |
5.3; 4.9; 2.8; 2.5; 1.4; 2.0 | — |
| 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 |
100; 100 | — |
| PRIMARY Anti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort |
12214.4; 3974.2 | — |
| 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 |
81.8 | — |
| 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 |
15.9; 4.7 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort |
4858.6; 21291.6; 10859.0; 4268.3; 20162.7; 10935.8 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort |
46.2; 46.4; 37.5; 40.0 | — |
| 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 |
4.4; 4.5; 2.2; 2.5; 3.0; 2.8 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort |
5105.9; 4856.6; 22141.6; 21054.9; 6743.4; 7249.2 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort |
37.7; 46.9; 31.3; 34.0 | — |
| PRIMARY Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort |
4.3; 4.3; 1.4; 1.5; 3.0; 3.5 | — |
| 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 |
100; 100 | — |
| PRIMARY Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort |
5950.9; 11025.1 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort |
13.3 | — |
| 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 |
1.9 | — |
| 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) |
100; 100; 100; 100; 100; 100 | — |
| 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) |
14.3; 23.6; 30.3; 46.2; 78.1; 72.9 | — |
| 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) |
55.2; 51.7; 43.3 | — |
| 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) |
3.2; 3.3; 2.4 | — |
| 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) |
97.0; 100 | — |
| PRIMARY RG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines) |
14.3; 48.3 | — |
| 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) |
54.5 | — |
| 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) |
3.4 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort |
20.0; 34.1; 19.5; 51.2; 27.1; 27.8 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 Cohort |
26.9; 42.9; 83.3; 55.0 | — |
| PRIMARY Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort |
1.7; 2.6; 1.4; 1.3; 7.8; 4.0 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 Cohort |
20.0; 18.9; 40.5; 44.8; 146.7; 256.5 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 Cohort |
34.0; 30.6; 77.1; 91.5 | — |
| PRIMARY Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort |
2.0; 2.4; 1.5; 1.4; 7.1; 13.8 | — |
| 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 |
100; 100 | — |
| PRIMARY RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort |
18.7; 22.4 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult FLU D-QIV-015 Cohort |
0.0 | — |
| 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 |
1.2 | — |
| 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) |
100; 96.3; 96.6; 100; 93.1; 100 | — |
| 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) |
15.6; 24.6; 24.8; 338.2; 78.1; 87.7 | — |
| 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) |
95.8; 55.6; 55.2 | — |
| 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) |
21.4; 3.0; 3.4 | — |
| 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) |
100; 100 | — |
| PRIMARY H1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines) |
18.8; 62.2 | — |
| 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) |
51.5 | — |
| 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 |
3.3 | — |
| 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 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort |
20.5; 68.2; 19.1; 78.0; 42.3; 47.2 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort |
65.4; 57.1; 62.5; 50.0 | — |
| PRIMARY Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort |
3.3; 4.0; 2.1; 2.1; 4.0; 3.6 | — |
| 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 |
100; 98.0; 100; 97.9; 100; 100 | — |
| PRIMARY H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort |
20.0; 18.4; 75.9; 94.1; 73.4; 72.2 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort |
64.2; 70.2; 52.1; 55.3 | — |
| PRIMARY Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort |
3.8; 5.2; 1.3; 1.9; 3.4; 4.2 | — |
| 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 |
96.7; 100 | — |
| PRIMARY H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort |
28.3; 118.9 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort |
57.1 | — |
| 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 |
4.3 | — |
| 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) |
100; 100; 100; 100; 100; 100 | — |
| 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) |
17.5; 25.5; 41.0; 186.6; 52.5; 60.6 | — |
| 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) |
84.6; 42.1; 6.9 | — |
| 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) |
9.9; 1.9; 1.4 | — |
| 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) |
100; 100 | — |
| PRIMARY H1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines) |
40.9; 56.6 | — |
| 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) |
3.3 | — |
| 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) |
1.3 | — |
| 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 |
92.3; 96.2; 89.7; 96.4; 96.0; 100 | — |
| PRIMARY H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort |
12.4; 19.0; 12.4; 24.4; 22.3; 26.9 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort |
15.4; 25.0; 25.0; 35.0 | — |
| PRIMARY Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort |
1.5; 1.9; 1.8; 2.0; 2.6; 2.2 | — |
| 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 |
96.2; 97.9; 100; 100; 97.9; 97.9 | — |
| PRIMARY H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort |
11.9; 13.7; 22.8; 27.0; 21.2; 23.2 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort |
18.9; 26.7; 22.9; 21.7 | — |
| PRIMARY Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort |
1.9; 2.1; 1.2; 1.3; 1.8; 1.7 | — |
| 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 |
96.6; 100 | — |
| PRIMARY H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort |
38.1; 312.2 | — |
| PRIMARY Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort |
77.8 | — |
| 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 |
8.2 | — |
| SECONDARY GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 Cohort |
45098.3; 37969.9; 46177.1; 38598.2; 21782.4; 24705.6 | — |
| SECONDARY GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 Cohort |
46013.8; 27845.9; 68348.8; 31718.0; 33610.2; 17401.9 | — |
| SECONDARY GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 Cohort |
25189.3; 16592.8; 31665.4; 19681.1; 20570.2; 15471.1 | — |
| SECONDARY Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 Cohort |
63.0; 52.2; 72.0; 60.0; 25.9; 32.0 | — |
| SECONDARY Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 Cohort |
34.5; 7.4; 55.2; 18.5; 13.8; 7.4 | — |
| SECONDARY Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 Cohort |
10.0; 6.7; 20.0; 3.3; 3.6; 3.3 | — |
| 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 |
17; 19; 20; 26; 19; 18 | — |
| 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 |
3; 0; 0; 0; 0; 27 | — |
| 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 |
17; 19; 7; 9; 4; 7 | — |
| SECONDARY Number of Subjects With Seropositivity Status Against Flu A/Indonesia/05/2005 (H5N1) HI Antibodies - Pediatric H5N1 Cohort |
33 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02415842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.