Trial Outcomes & Findings for 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 (NCT NCT02415842)
NCT ID: NCT02415842
Last Updated: 2019-07-23
Results Overview
With respect to samples from HA Group 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)
COMPLETED
414 participants
At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)
2019-07-23
Participant Flow
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).
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\[114464\]).
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
29
|
27
|
30
|
30
|
30
|
26
|
29
|
53
|
49
|
33
|
20
|
|
Overall Study
COMPLETED
|
29
|
29
|
29
|
27
|
30
|
30
|
30
|
26
|
29
|
53
|
49
|
33
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This category applies to H5N1\_PAS and H5N1\_PCN groups (pediatric groups). This category is not applicable to any of the adults groups.
Baseline characteristics by cohort
| Measure |
H1N1_AS
n=29 Participants
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
|
H1N1_NAS
n=29 Participants
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
|
H5N1_AS
n=29 Participants
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
|
H5N1_NAS
n=27 Participants
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
|
H9N2_AS
n=30 Participants
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.
|
H9N2_NAS
n=30 Participants
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.
|
DQIV_NAS
n=30 Participants
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.
|
QPAN5_C
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_VT
n=53 Participants
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.
|
H5N1_IN
n=49 Participants
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
|
H5N1_PAS
n=33 Participants
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.
|
H5N1_PCN
n=20 Participants
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.
|
Total
n=414 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
33 Participants
n=33 Participants
|
20 Participants
n=20 Participants
|
53 Participants
n=414 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=29 Participants
|
29 Participants
n=29 Participants
|
29 Participants
n=29 Participants
|
27 Participants
n=27 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
26 Participants
n=26 Participants
|
29 Participants
n=29 Participants
|
53 Participants
n=53 Participants
|
49 Participants
n=49 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=20 Participants
|
361 Participants
n=414 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=414 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=29 Participants
|
18 Participants
n=29 Participants
|
17 Participants
n=29 Participants
|
18 Participants
n=27 Participants
|
14 Participants
n=30 Participants
|
16 Participants
n=30 Participants
|
22 Participants
n=30 Participants
|
12 Participants
n=26 Participants
|
16 Participants
n=29 Participants
|
21 Participants
n=53 Participants
|
28 Participants
n=49 Participants
|
16 Participants
n=33 Participants
|
10 Participants
n=20 Participants
|
227 Participants
n=414 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=29 Participants
|
11 Participants
n=29 Participants
|
12 Participants
n=29 Participants
|
9 Participants
n=27 Participants
|
16 Participants
n=30 Participants
|
14 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
14 Participants
n=26 Participants
|
13 Participants
n=29 Participants
|
32 Participants
n=53 Participants
|
21 Participants
n=49 Participants
|
17 Participants
n=33 Participants
|
10 Participants
n=20 Participants
|
187 Participants
n=414 Participants
|
|
Race/Ethnicity, Customized
American Hispanic or Latino
|
2 Participants
n=29 Participants
|
1 Participants
n=29 Participants
|
5 Participants
n=29 Participants
|
4 Participants
n=27 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=26 Participants
|
4 Participants
n=29 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
3 Participants
n=33 Participants
|
0 Participants
n=20 Participants
|
26 Participants
n=414 Participants
|
|
Race/Ethnicity, Customized
Not American Hispanic or Latino
|
27 Participants
n=29 Participants
|
28 Participants
n=29 Participants
|
24 Participants
n=29 Participants
|
23 Participants
n=27 Participants
|
28 Participants
n=30 Participants
|
28 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
23 Participants
n=26 Participants
|
25 Participants
n=29 Participants
|
53 Participants
n=53 Participants
|
49 Participants
n=49 Participants
|
30 Participants
n=33 Participants
|
20 Participants
n=20 Participants
|
358 Participants
n=414 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=20 Participants
|
30 Participants
n=414 Participants
|
|
Age continuous-pediatric study
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22.6 Months
STANDARD_DEVIATION 7.6 • n=33 Participants • This category applies to H5N1\_PAS and H5N1\_PCN groups (pediatric groups). This category is not applicable to any of the adults groups.
|
23.5 Months
STANDARD_DEVIATION 6.9 • n=20 Participants • This category applies to H5N1\_PAS and H5N1\_PCN groups (pediatric groups). This category is not applicable to any of the adults groups.
|
22.9 Months
STANDARD_DEVIATION 7.3 • n=53 Participants • This category applies to H5N1\_PAS and H5N1\_PCN groups (pediatric groups). This category is not applicable to any of the adults groups.
|
|
Age continuous- adults subjects
|
28.5 Years
STANDARD_DEVIATION 6.5 • n=29 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
29.3 Years
STANDARD_DEVIATION 6.8 • n=29 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
30.4 Years
STANDARD_DEVIATION 8.3 • n=29 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
31.4 Years
STANDARD_DEVIATION 9.1 • n=27 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
43.3 Years
STANDARD_DEVIATION 11.9 • n=30 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
42.6 Years
STANDARD_DEVIATION 13.6 • n=30 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
26.7 Years
STANDARD_DEVIATION 5.7 • n=30 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
29.4 Years
STANDARD_DEVIATION 6.5 • n=26 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
29.6 Years
STANDARD_DEVIATION 6.8 • n=29 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
35.8 Years
STANDARD_DEVIATION 12.1 • n=53 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
35.4 Years
STANDARD_DEVIATION 12.5 • n=49 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
—
|
—
|
32.9 Years
STANDARD_DEVIATION 9.1 • n=361 Participants • This category applies to the adults groups. This category is not applicable to H5N1\_PAS and H5N1\_PCN groups (pediatric groups).
|
PRIMARY outcome
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)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.
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).
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
H5N1_NAS
n=27 Participants
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
|
H9N2_AS
n=30 Participants
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.
|
H9N2_NAS
n=30 Participants
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
100 Percentage of subjects
Interval 86.3 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
100 Percentage of subjects
Interval 86.3 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
—
|
—
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
H5N1_NAS
n=27 Participants
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
|
H9N2_AS
n=30 Participants
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.
|
H9N2_NAS
n=30 Participants
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 0
|
6935.6 EU/mL
Interval 4974.4 to 9670.0
|
6841.5 EU/mL
Interval 4954.4 to 9447.5
|
14381.9 EU/mL
Interval 10313.7 to 20054.7
|
14552.3 EU/mL
Interval 10670.0 to 19847.2
|
12799.7 EU/mL
Interval 10297.3 to 15910.2
|
10888.1 EU/mL
Interval 8004.1 to 14811.3
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 21
|
45098.3 EU/mL
Interval 34775.1 to 58486.2
|
37969.9 EU/mL
Interval 26930.8 to 53534.1
|
46013.8 EU/mL
Interval 33592.9 to 63027.5
|
27845.9 EU/mL
Interval 20269.3 to 38254.5
|
25189.3 EU/mL
Interval 20983.6 to 30238.0
|
16592.8 EU/mL
Interval 13332.5 to 20650.4
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 42
|
46177.1 EU/mL
Interval 37510.4 to 56846.2
|
38598.2 EU/mL
Interval 27818.0 to 53555.9
|
68348.8 EU/mL
Interval 53244.4 to 87738.1
|
31718.0 EU/mL
Interval 23755.4 to 42349.5
|
31665.4 EU/mL
Interval 27405.9 to 36587.0
|
19681.1 EU/mL
Interval 16293.6 to 23772.7
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 182
|
21782.4 EU/mL
Interval 17803.2 to 26651.0
|
24705.6 EU/mL
Interval 18369.2 to 33227.7
|
33610.2 EU/mL
Interval 26464.5 to 42685.3
|
17401.9 EU/mL
Interval 13330.1 to 22717.5
|
20570.2 EU/mL
Interval 16717.6 to 25310.5
|
15471.1 EU/mL
Interval 11913.9 to 20090.4
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 385
|
—
|
—
|
25346.9 EU/mL
Interval 20205.0 to 31797.3
|
15768.2 EU/mL
Interval 11999.3 to 20720.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=27 Participants
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.
|
QPAN5_G
n=25 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
H5N1_NAS
n=27 Participants
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
|
H9N2_AS
n=30 Participants
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.
|
H9N2_NAS
n=30 Participants
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 21
|
63.0 Percentage of subjects
Interval 42.4 to 80.6
|
52.2 Percentage of subjects
Interval 30.6 to 73.2
|
34.5 Percentage of subjects
Interval 17.9 to 54.3
|
7.4 Percentage of subjects
Interval 0.9 to 24.3
|
10.0 Percentage of subjects
Interval 2.1 to 26.5
|
6.7 Percentage of subjects
Interval 0.8 to 22.1
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
72.0 Percentage of subjects
Interval 50.6 to 87.9
|
60.0 Percentage of subjects
Interval 38.7 to 78.9
|
55.2 Percentage of subjects
Interval 35.7 to 73.6
|
18.5 Percentage of subjects
Interval 6.3 to 38.1
|
20.0 Percentage of subjects
Interval 7.7 to 38.6
|
3.3 Percentage of subjects
Interval 0.1 to 17.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=27 Participants
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.
|
QPAN5_G
n=25 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
H5N1_NAS
n=27 Participants
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
|
H9N2_AS
n=30 Participants
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.
|
H9N2_NAS
n=30 Participants
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 21
|
29.6 Percentage of subjects
Interval 13.8 to 50.2
|
34.8 Percentage of subjects
Interval 16.4 to 57.3
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
3.7 Percentage of subjects
Interval 0.1 to 19.0
|
0.0 Percentage of subjects
Interval 0.0 to 11.6
|
0.0 Percentage of subjects
Interval 0.0 to 11.6
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
36.0 Percentage of subjects
Interval 18.0 to 57.5
|
28.0 Percentage of subjects
Interval 12.1 to 49.4
|
20.7 Percentage of subjects
Interval 8.0 to 39.7
|
7.4 Percentage of subjects
Interval 0.9 to 24.3
|
0.0 Percentage of subjects
Interval 0.0 to 11.6
|
0.0 Percentage of subjects
Interval 0.0 to 11.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 )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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=27 Participants
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.
|
QPAN5_G
n=25 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
H5N1_NAS
n=27 Participants
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
|
H9N2_AS
n=30 Participants
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.
|
H9N2_NAS
n=30 Participants
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 21
|
6.5 Ratio
Interval 4.7 to 9.2
|
5.9 Ratio
Interval 3.6 to 9.6
|
3.2 Ratio
Interval 2.3 to 4.5
|
1.9 Ratio
Interval 1.4 to 2.7
|
2.0 Ratio
Interval 1.6 to 2.4
|
1.5 Ratio
Interval 1.3 to 1.8
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
7.0 Ratio
Interval 5.0 to 9.7
|
5.6 Ratio
Interval 3.6 to 8.7
|
4.8 Ratio
Interval 3.5 to 6.4
|
2.2 Ratio
Interval 1.6 to 3.0
|
2.5 Ratio
Interval 2.1 to 3.0
|
1.8 Ratio
Interval 1.5 to 2.1
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
3.2 Ratio
Interval 2.4 to 4.1
|
3.6 Ratio
Interval 2.4 to 5.3
|
2.3 Ratio
Interval 1.8 to 3.1
|
1.2 Ratio
Interval 1.0 to 1.5
|
1.6 Ratio
Interval 1.4 to 1.9
|
1.4 Ratio
Interval 1.2 to 1.6
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
—
|
—
|
1.8 Ratio
Interval 1.4 to 2.2
|
1.1 Ratio
Interval 0.9 to 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
QPAN5_G
n=19 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 89.1 to 100.0
|
100 Percentage of subjects
Interval 80.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
100 Percentage of subjects
Interval 81.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
100 Percentage of subjects
Interval 81.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 82.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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).
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
QPAN5_G
n=19 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 0
|
2075.4 EU/mL
Interval 1458.3 to 2953.6
|
2123.2 EU/mL
Interval 1042.1 to 4325.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 21
|
16552.4 EU/mL
Interval 9239.4 to 29653.7
|
2203.3 EU/mL
Interval 1237.8 to 3922.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 42
|
22195.2 EU/mL
Interval 14601.3 to 33738.6
|
2272.1 EU/mL
Interval 1310.1 to 3940.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 385
|
8661.1 EU/mL
Interval 5352.5 to 14014.8
|
2394.7 EU/mL
Interval 1446.6 to 3964.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=32 Participants
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.
|
QPAN5_G
n=17 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 21
|
59.4 Percentage of subjects
Interval 40.6 to 76.3
|
0.0 Percentage of subjects
Interval 0.0 to 19.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 42
|
71.9 Percentage of subjects
Interval 53.3 to 86.3
|
0.0 Percentage of subjects
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=32 Participants
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.
|
QPAN5_G
n=17 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 21
|
40.6 Percentage of subjects
Interval 23.7 to 59.4
|
0.0 Percentage of subjects
Interval 0.0 to 19.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 42
|
53.1 Percentage of subjects
Interval 34.7 to 70.9
|
0.0 Percentage of subjects
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=32 Participants
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.
|
QPAN5_G
n=17 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 21
|
8.8 Ratio
Interval 5.0 to 15.6
|
1.1 Ratio
Interval 0.9 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 42
|
11.3 Ratio
Interval 7.3 to 17.7
|
1.0 Ratio
Interval 0.8 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 385
|
4.1 Ratio
Interval 2.3 to 7.2
|
1.4 Ratio
Interval 1.0 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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).
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 224
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 549
|
100 Percentage of subjects
Interval 86.3 to 100.0
|
100 Percentage of subjects
Interval 83.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 591
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 729
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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).
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 0
|
8946.2 EU/mL
Interval 6147.1 to 13019.9
|
9205.1 EU/mL
Interval 6434.5 to 13168.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 42
|
35325.3 EU/mL
Interval 25353.6 to 49218.9
|
10171.2 EU/mL
Interval 7035.3 to 14705.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 182
|
22057.9 EU/mL
Interval 15456.7 to 31478.3
|
10123.1 EU/mL
Interval 6701.6 to 15291.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 224
|
18748.2 EU/mL
Interval 13219.8 to 26588.7
|
43267.9 EU/mL
Interval 31807.8 to 58856.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 549
|
21272.5 EU/mL
Interval 16188.8 to 27952.7
|
23507.6 EU/mL
Interval 16503.6 to 33484.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 591
|
29023.7 EU/mL
Interval 22329.1 to 37725.4
|
33113.7 EU/mL
Interval 23879.1 to 45919.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 729
|
22445.9 EU/mL
Interval 17120.0 to 29428.7
|
21894.3 EU/mL
Interval 15168.5 to 31602.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 42
|
50.0 Percentage of subjects
Interval 29.9 to 70.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 224
|
15.4 Percentage of subjects
Interval 4.4 to 34.9
|
46.4 Percentage of subjects
Interval 27.5 to 66.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 591
|
29.2 Percentage of subjects
Interval 12.6 to 51.1
|
50.0 Percentage of subjects
Interval 27.2 to 72.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 42
|
23.1 Percentage of subjects
Interval 9.0 to 43.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 224
|
0.0 Percentage of subjects
Interval 0.0 to 13.2
|
25.0 Percentage of subjects
Interval 10.7 to 44.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 591
|
4.2 Percentage of subjects
Interval 0.1 to 21.1
|
5.0 Percentage of subjects
Interval 0.1 to 24.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 42
|
3.9 Ratio
Interval 2.8 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 182
|
2.5 Ratio
Interval 2.0 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 224
|
2.1 Ratio
Interval 1.7 to 2.6
|
4.0 Ratio
Interval 2.5 to 6.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 549
|
2.3 Ratio
Interval 1.7 to 3.1
|
2.0 Ratio
Interval 1.5 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 591
|
3.1 Ratio
Interval 2.2 to 4.2
|
2.9 Ratio
Interval 1.9 to 4.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 729
|
2.4 Ratio
Interval 1.8 to 3.2
|
1.9 Ratio
Interval 1.3 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 6
|
100 Percentage of subjects
Interval 93.0 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12
|
100 Percentage of subjects
Interval 92.9 to 100.0
|
100 Percentage of subjects
Interval 92.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12 + 21 days
|
100 Percentage of subjects
Interval 92.6 to 100.0
|
100 Percentage of subjects
Interval 92.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 18
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
100 Percentage of subjects
Interval 92.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort
Day 0
|
9340.1 EU/mL
Interval 7411.6 to 11770.5
|
8409.3 EU/mL
Interval 6746.1 to 10482.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort
Day 21
|
35805.4 EU/mL
Interval 29821.1 to 42990.6
|
40245.6 EU/mL
Interval 31912.9 to 50753.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort
Month 6
|
16123.6 EU/mL
Interval 13232.7 to 19646.1
|
17337.3 EU/mL
Interval 13536.2 to 22206.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort
Month 12
|
14548.7 EU/mL
Interval 11989.4 to 17654.2
|
16242.1 EU/mL
Interval 12854.0 to 20523.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort
Month 12 + 21 days
|
32675.5 EU/mL
Interval 27585.4 to 38704.8
|
37096.0 EU/mL
Interval 29342.0 to 46899.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort
Month 18
|
21154.6 EU/mL
Interval 17597.8 to 25430.2
|
19508.2 EU/mL
Interval 15715.0 to 24217.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort
Day 21
|
39.6 Percentage of subjects
Interval 26.5 to 54.0
|
55.1 Percentage of subjects
Interval 40.2 to 69.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort
Month 12 + 21 days
|
39.6 Percentage of subjects
Interval 25.8 to 54.7
|
46.8 Percentage of subjects
Interval 32.1 to 61.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort
Day 21
|
15.1 Percentage of subjects
Interval 6.7 to 27.6
|
18.4 Percentage of subjects
Interval 8.8 to 32.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort
Month 12 + 21 days
|
14.6 Percentage of subjects
Interval 6.1 to 27.8
|
21.3 Percentage of subjects
Interval 10.7 to 35.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Day 21
|
3.8 Ratio
Interval 3.0 to 5.0
|
4.8 Ratio
Interval 3.7 to 6.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Month 6
|
1.7 Ratio
Interval 1.5 to 2.1
|
2.1 Ratio
Interval 1.7 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Month 12
|
1.6 Ratio
Interval 1.4 to 1.8
|
1.9 Ratio
Interval 1.6 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Month 12 + 21 days
|
3.6 Ratio
Interval 2.8 to 4.8
|
4.5 Ratio
Interval 3.4 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Month 18
|
2.3 Ratio
Interval 1.8 to 2.9
|
2.5 Ratio
Interval 1.9 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 Cohort
Day 0
|
11215.8 EU/mL
Interval 8015.8 to 15693.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 Cohort
Day 21
|
30437.5 EU/mL
Interval 24261.2 to 38186.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort
|
33.3 Percentage of subjects
Interval 17.3 to 52.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort
|
3.3 Percentage of subjects
Interval 0.1 to 17.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose1) compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 2.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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).
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 21
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 182
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 385
|
—
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
Day 0
|
11.0 Titer
Interval 10.0 to 12.1
|
18.6 Titer
Interval 14.4 to 24.1
|
30.3 Titer
Interval 19.1 to 48.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
Day 21
|
30.8 Titer
Interval 23.1 to 40.9
|
40.0 Titer
Interval 29.0 to 55.2
|
60.6 Titer
Interval 37.9 to 96.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
Day 42
|
33.0 Titer
Interval 25.7 to 42.6
|
64.5 Titer
Interval 47.0 to 88.5
|
91.9 Titer
Interval 62.0 to 136.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
Day 182
|
18.2 Titer
Interval 14.3 to 23.1
|
44.0 Titer
Interval 31.9 to 60.7
|
58.0 Titer
Interval 35.4 to 95.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)
Day 385
|
—
|
33.0 Titer
Interval 25.2 to 43.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 21
|
44.8 Percentage of subjects
Interval 26.4 to 64.3
|
27.6 Percentage of subjects
Interval 12.7 to 47.2
|
23.3 Percentage of subjects
Interval 9.9 to 42.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
51.7 Percentage of subjects
Interval 32.5 to 70.6
|
65.5 Percentage of subjects
Interval 45.7 to 82.1
|
46.7 Percentage of subjects
Interval 28.3 to 65.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 21
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
6.7 Percentage of subjects
Interval 0.8 to 22.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
6.7 Percentage of subjects
Interval 0.8 to 22.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 )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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 21
|
2.8 Ratio
Interval 2.0 to 3.8
|
2.1 Ratio
Interval 1.6 to 2.9
|
2.0 Ratio
Interval 1.4 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
3.0 Ratio
Interval 2.3 to 4.0
|
3.5 Ratio
Interval 2.6 to 4.6
|
3.0 Ratio
Interval 2.2 to 4.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 182
|
1.7 Ratio
Interval 1.3 to 2.1
|
2.4 Ratio
Interval 1.7 to 3.3
|
2.0 Ratio
Interval 1.4 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 385
|
—
|
1.8 Ratio
Interval 1.3 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 21
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 385
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
Day 0
|
19.2 Titer
Interval 15.1 to 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
Day 21
|
43.5 Titer
Interval 30.3 to 62.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
Day 42
|
44.4 Titer
Interval 32.7 to 60.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
Day 385
|
22.4 Titer
Interval 17.1 to 29.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 21
|
39.4 Percentage of subjects
Interval 22.9 to 57.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
39.4 Percentage of subjects
Interval 22.9 to 57.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 21
|
6.1 Percentage of subjects
Interval 0.7 to 20.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
3.0 Percentage of subjects
Interval 0.1 to 15.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 21
|
2.3 Ratio
Interval 1.6 to 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
2.3 Ratio
Interval 1.6 to 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
1.1 Ratio
Interval 0.8 to 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 224
|
—
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 549
|
100 Percentage of subjects
Interval 86.3 to 100.0
|
100 Percentage of subjects
Interval 83.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 591
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 729
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 0
|
18.5 Titer
Interval 15.4 to 22.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 42
|
48.2 Titer
Interval 34.9 to 66.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 182
|
40.0 Titer
Interval 32.0 to 50.0
|
15.4 Titer
Interval 13.3 to 17.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 224
|
—
|
51.2 Titer
Interval 37.2 to 70.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 549
|
31.2 Titer
Interval 23.4 to 41.4
|
27.8 Titer
Interval 21.1 to 36.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 591
|
40.0 Titer
Interval 31.8 to 50.3
|
40.0 Titer
Interval 28.7 to 55.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 729
|
49.0 Titer
Interval 38.7 to 62.0
|
36.1 Titer
Interval 26.6 to 48.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 42
|
42.3 Percentage of subjects
Interval 23.4 to 63.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 224
|
—
|
57.1 Percentage of subjects
Interval 37.2 to 75.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 591
|
25.0 Percentage of subjects
Interval 9.8 to 46.7
|
45.0 Percentage of subjects
Interval 23.1 to 68.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 42
|
7.7 Percentage of subjects
Interval 0.9 to 25.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 224
|
—
|
7.1 Percentage of subjects
Interval 0.9 to 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 591
|
0.0 Percentage of subjects
Interval 0.0 to 14.2
|
0.0 Percentage of subjects
Interval 0.0 to 16.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 42
|
2.6 Ratio
Interval 1.8 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 182
|
2.2 Ratio
Interval 1.7 to 2.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 224
|
—
|
3.3 Ratio
Interval 2.4 to 4.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 549
|
1.7 Ratio
Interval 1.2 to 2.4
|
1.8 Ratio
Interval 1.3 to 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 591
|
2.1 Ratio
Interval 1.6 to 2.8
|
2.5 Ratio
Interval 1.8 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 729
|
2.6 Ratio
Interval 1.9 to 3.5
|
2.3 Ratio
Interval 1.7 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 6
|
100 Percentage of subjects
Interval 93.0 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12
|
100 Percentage of subjects
Interval 92.9 to 100.0
|
100 Percentage of subjects
Interval 92.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12 + 21 days
|
100 Percentage of subjects
Interval 92.6 to 100.0
|
100 Percentage of subjects
Interval 92.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 18
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
97.8 Percentage of subjects
Interval 88.2 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort
Day 0
|
19.0 Titer
Interval 15.8 to 22.8
|
26.5 Titer
Interval 21.9 to 32.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort
Day 21
|
56.9 Titer
Interval 45.8 to 70.8
|
106.2 Titer
Interval 84.1 to 134.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort
Month 6
|
30.1 Titer
Interval 25.6 to 35.3
|
29.3 Titer
Interval 24.1 to 35.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort
Month 12
|
25.3 Titer
Interval 21.6 to 29.6
|
40.6 Titer
Interval 32.6 to 50.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort
Month 12 + 21 days
|
40.0 Titer
Interval 33.1 to 48.4
|
74.3 Titer
Interval 59.1 to 93.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort
Month 18
|
32.4 Titer
Interval 27.1 to 38.7
|
32.7 Titer
Interval 26.5 to 40.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 Cohort
Day 21
|
49.1 Percentage of subjects
Interval 35.1 to 63.2
|
67.3 Percentage of subjects
Interval 52.5 to 80.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 Cohort
Month 12 + 21 days
|
31.3 Percentage of subjects
Interval 18.7 to 46.3
|
51.1 Percentage of subjects
Interval 36.1 to 65.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 Cohort
Day 21
|
9.4 Percentage of subjects
Interval 3.1 to 20.7
|
12.2 Percentage of subjects
Interval 4.6 to 24.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 Cohort
Month 12 + 21 days
|
4.2 Percentage of subjects
Interval 0.5 to 14.3
|
6.4 Percentage of subjects
Interval 1.3 to 17.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Day 21
|
3.0 Ratio
Interval 2.3 to 3.9
|
4.0 Ratio
Interval 3.1 to 5.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Month 6
|
1.6 Ratio
Interval 1.3 to 2.0
|
1.1 Ratio
Interval 0.9 to 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Month 12
|
1.3 Ratio
Interval 1.1 to 1.6
|
1.5 Ratio
Interval 1.2 to 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Month 12 + 21 days
|
2.1 Ratio
Interval 1.6 to 2.7
|
2.9 Ratio
Interval 2.2 to 3.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Month 18
|
1.7 Ratio
Interval 1.4 to 2.2
|
1.3 Ratio
Interval 1.0 to 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
Day 0
|
28.3 Titer
Interval 22.9 to 35.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
Day 21
|
76.4 Titer
Interval 57.3 to 101.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult FLU D-QIV-015 Cohort
|
53.3 Percentage of subjects
Interval 34.3 to 71.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult FLU D-QIV-015 Cohort
|
10.0 Percentage of subjects
Interval 2.1 to 26.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose1) compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 1.8 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
—
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 0
|
3697.2 EU/mL
Interval 2695.5 to 5071.1
|
8366.5 EU/mL
Interval 5770.6 to 12130.2
|
14704.5 EU/mL
Interval 10160.7 to 21280.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 42
|
20783.2 EU/mL
Interval 16291.5 to 26513.4
|
51118.1 EU/mL
Interval 39968.6 to 65378.0
|
36716.0 EU/mL
Interval 27343.3 to 49301.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 182
|
12674.3 EU/mL
Interval 9909.2 to 16210.9
|
—
|
23927.1 EU/mL
Interval 17505.5 to 32704.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 385
|
—
|
19903.0 EU/mL
Interval 15283.4 to 25919.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=25 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 50.6 to 87.9
|
62.1 Percentage of subjects
Interval 42.3 to 79.3
|
20.0 Percentage of subjects
Interval 7.7 to 38.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=25 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 42
|
6.0 Ratio
Interval 4.4 to 8.0
|
6.1 Ratio
Interval 4.3 to 8.7
|
2.5 Ratio
Interval 2.0 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
3.5 Ratio
Interval 2.8 to 4.4
|
—
|
1.8 Ratio
Interval 1.5 to 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
—
|
2.4 Ratio
Interval 1.9 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 42
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 42
|
20542.9 EU/mL
Interval 15121.2 to 27908.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 385
|
7258.3 EU/mL
Interval 4703.9 to 11199.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 82.2 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 42
|
17.1 Ratio
Interval 11.7 to 25.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
5.5 Ratio
Interval 3.1 to 9.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 224
|
—
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 549
|
100 Percentage of subjects
Interval 86.3 to 100.0
|
100 Percentage of subjects
Interval 83.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 591
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 729
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 0
|
5832.4 EU/mL
Interval 4271.3 to 7964.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 42
|
23187.8 EU/mL
Interval 16597.1 to 32395.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 182
|
15364.4 EU/mL
Interval 11057.9 to 21347.9
|
6914.7 EU/mL
Interval 4722.5 to 10124.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 224
|
—
|
34071.6 EU/mL
Interval 25325.9 to 45837.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 549
|
12974.0 EU/mL
Interval 10089.8 to 16682.7
|
15142.3 EU/mL
Interval 10406.0 to 22034.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 591
|
21467.9 EU/mL
Interval 16930.0 to 27222.1
|
24791.3 EU/mL
Interval 18324.3 to 33540.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 729
|
14534.4 EU/mL
Interval 11280.4 to 18727.3
|
13865.1 EU/mL
Interval 9476.2 to 20286.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 42
|
50.0 Percentage of subjects
Interval 29.9 to 70.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 224
|
—
|
46.4 Percentage of subjects
Interval 27.5 to 66.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 591
|
45.8 Percentage of subjects
Interval 25.6 to 67.2
|
55.0 Percentage of subjects
Interval 31.5 to 76.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 42
|
4.0 Ratio
Interval 2.8 to 5.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 224
|
—
|
4.7 Ratio
Interval 3.0 to 7.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 549
|
2.2 Ratio
Interval 1.6 to 2.9
|
2.0 Ratio
Interval 1.5 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 591
|
3.6 Ratio
Interval 2.7 to 4.6
|
3.3 Ratio
Interval 2.2 to 4.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 729
|
4.7 Ratio
Interval 3.0 to 7.3
|
1.8 Ratio
Interval 1.3 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12
|
100 Percentage of subjects
Interval 92.9 to 100.0
|
100 Percentage of subjects
Interval 92.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12 + 21 days
|
100 Percentage of subjects
Interval 92.6 to 100.0
|
100 Percentage of subjects
Interval 92.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 18
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
100 Percentage of subjects
Interval 92.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
Day 0
|
8735.3 EU/mL
Interval 6375.6 to 11968.5
|
8633.4 EU/mL
Interval 6344.7 to 11747.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
Day 21
|
34355.8 EU/mL
Interval 26840.9 to 43974.8
|
40833.0 EU/mL
Interval 31899.1 to 52269.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
Month 12
|
14575.6 EU/mL
Interval 11067.3 to 19196.0
|
15958.9 EU/mL
Interval 12427.1 to 20494.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
Month 12 + 21 days
|
48534.4 EU/mL
Interval 39207.4 to 60080.4
|
51228.3 EU/mL
Interval 40614.9 to 64615.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
Month 18
|
23376.4 EU/mL
Interval 18227.7 to 29979.3
|
20685.0 EU/mL
Interval 16219.1 to 26380.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort
Day 21
|
41.5 Percentage of subjects
Interval 28.1 to 55.9
|
51.0 Percentage of subjects
Interval 36.3 to 65.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort
Month 12 + 21 days
|
56.3 Percentage of subjects
Interval 41.2 to 70.5
|
61.7 Percentage of subjects
Interval 46.4 to 75.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Day 21
|
3.9 Ratio
Interval 3.0 to 5.1
|
4.7 Ratio
Interval 3.7 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Month 12
|
1.7 Ratio
Interval 1.4 to 2.0
|
1.8 Ratio
Interval 1.5 to 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Month 12 + 21 days
|
5.6 Ratio
Interval 4.0 to 8.0
|
6.1 Ratio
Interval 4.5 to 8.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Month 18
|
2.6 Ratio
Interval 1.9 to 3.6
|
2.5 Ratio
Interval 2.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort
Day 0
|
6435.6 EU/mL
Interval 4852.3 to 8535.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort
Day 21
|
12074.6 EU/mL
Interval 9400.2 to 15509.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 0.8 to 22.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose1) compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 1.6 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 42
|
100 Percentage of subjects
Interval 87.2 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
—
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 42
|
15959.9 EU/mL
Interval 12897.9 to 19748.9
|
28492.2 EU/mL
Interval 21814.5 to 37214.0
|
19636.8 EU/mL
Interval 16519.2 to 23342.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 182
|
7791.5 EU/mL
Interval 6301.3 to 9634.2
|
—
|
9859.5 EU/mL
Interval 7806.5 to 12452.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts
Day 385
|
—
|
11491.9 EU/mL
Interval 8848.8 to 14924.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=25 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 27.8 to 68.7
|
51.7 Percentage of subjects
Interval 32.5 to 70.6
|
30.0 Percentage of subjects
Interval 14.7 to 49.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=27 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 42
|
5.3 Ratio
Interval 3.6 to 8.0
|
4.9 Ratio
Interval 3.5 to 6.9
|
2.8 Ratio
Interval 2.3 to 3.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
2.5 Ratio
Interval 1.8 to 3.4
|
—
|
1.4 Ratio
Interval 1.2 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
—
|
2.0 Ratio
Interval 1.6 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 42
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 42
|
12214.4 EU/mL
Interval 8399.6 to 17761.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort
Day 385
|
3974.2 EU/mL
Interval 2548.8 to 6196.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 64.5 to 93.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 42
|
15.9 Ratio
Interval 9.9 to 25.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 385
|
4.7 Ratio
Interval 2.7 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 224
|
—
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 549
|
100 Percentage of subjects
Interval 86.3 to 100.0
|
100 Percentage of subjects
Interval 83.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 591
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 729
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 0
|
4858.6 EU/mL
Interval 3288.8 to 7177.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 42
|
21291.6 EU/mL
Interval 15138.2 to 29946.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 182
|
10859.0 EU/mL
Interval 7483.4 to 15757.2
|
4268.3 EU/mL
Interval 2736.3 to 6658.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 224
|
—
|
20162.7 EU/mL
Interval 14733.6 to 27592.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 549
|
10935.8 EU/mL
Interval 8226.0 to 14538.4
|
12308.9 EU/mL
Interval 8353.2 to 18138.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 591
|
15362.8 EU/mL
Interval 11801.3 to 19999.2
|
14064.2 EU/mL
Interval 9991.3 to 19797.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort
Day 729
|
11917.5 EU/mL
Interval 8775.7 to 16184.0
|
10921.9 EU/mL
Interval 7313.7 to 16310.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 42
|
46.2 Percentage of subjects
Interval 26.6 to 66.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 224
|
—
|
46.4 Percentage of subjects
Interval 27.5 to 66.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort
Day 591
|
37.5 Percentage of subjects
Interval 18.8 to 59.4
|
40.0 Percentage of subjects
Interval 19.1 to 63.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 42
|
4.4 Ratio
Interval 3.1 to 6.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 224
|
—
|
4.5 Ratio
Interval 2.7 to 7.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 549
|
2.2 Ratio
Interval 1.6 to 2.9
|
2.5 Ratio
Interval 1.7 to 3.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 591
|
3.0 Ratio
Interval 2.1 to 4.2
|
2.8 Ratio
Interval 1.9 to 4.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 729
|
2.3 Ratio
Interval 1.7 to 3.2
|
2.2 Ratio
Interval 1.6 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12
|
100 Percentage of subjects
Interval 92.9 to 100.0
|
100 Percentage of subjects
Interval 92.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12 + 21 days
|
100 Percentage of subjects
Interval 92.6 to 100.0
|
100 Percentage of subjects
Interval 92.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 18
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
100 Percentage of subjects
Interval 92.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
Day 0
|
5105.9 EU/mL
Interval 3937.3 to 6621.4
|
4856.6 EU/mL
Interval 3949.9 to 5971.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
Day 21
|
22141.6 EU/mL
Interval 18114.4 to 27064.1
|
21054.9 EU/mL
Interval 16966.2 to 26129.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
Month 12
|
6743.4 EU/mL
Interval 5489.0 to 8284.6
|
7249.2 EU/mL
Interval 5785.2 to 9083.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
Month 12 + 21 days
|
14532.2 EU/mL
Interval 12132.7 to 17406.2
|
16655.6 EU/mL
Interval 13122.9 to 21139.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort
Month 18
|
9467.3 EU/mL
Interval 7750.0 to 11565.2
|
10315.9 EU/mL
Interval 8230.5 to 12929.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort
Day 21
|
37.7 Percentage of subjects
Interval 24.8 to 52.1
|
46.9 Percentage of subjects
Interval 32.5 to 61.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort
Month 12 + 21 days
|
31.3 Percentage of subjects
Interval 18.7 to 46.3
|
34.0 Percentage of subjects
Interval 20.9 to 49.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Day 21
|
4.3 Ratio
Interval 3.2 to 5.8
|
4.3 Ratio
Interval 3.4 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Month 12
|
1.4 Ratio
Interval 1.2 to 1.6
|
1.5 Ratio
Interval 1.2 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Month 12 + 21 days
|
3.0 Ratio
Interval 2.3 to 4.1
|
3.5 Ratio
Interval 2.7 to 4.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort
Month 18
|
1.9 Ratio
Interval 1.5 to 2.5
|
2.3 Ratio
Interval 1.8 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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)
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort
Day 0
|
5950.9 EU/mL
Interval 4212.2 to 8407.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort
Day 21
|
11025.1 EU/mL
Interval 8572.8 to 14178.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 3.8 to 30.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose1) compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 1.4 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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 )
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
14.3 Titer
Interval 12.1 to 16.9
|
23.6 Titer
Interval 16.9 to 33.1
|
30.3 Titer
Interval 23.6 to 39.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
46.2 Titer
Interval 34.1 to 62.5
|
78.1 Titer
Interval 54.0 to 113.0
|
72.9 Titer
Interval 55.7 to 95.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 35.7 to 73.6
|
51.7 Percentage of subjects
Interval 32.5 to 70.6
|
43.3 Percentage of subjects
Interval 25.5 to 62.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 2.4 to 4.4
|
3.3 Ratio
Interval 2.5 to 4.5
|
2.4 Ratio
Interval 1.9 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
97.0 Percentage of subjects
Interval 84.2 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
Day 0
|
14.3 Titer
Interval 11.6 to 17.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
Day 42
|
48.3 Titer
Interval 38.0 to 61.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 36.4 to 71.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 2.5 to 4.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
—
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 224
|
—
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 549
|
100 Percentage of subjects
Interval 86.3 to 100.0
|
100 Percentage of subjects
Interval 83.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 591
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 0
|
20.0 Titer
Interval 15.2 to 26.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 42
|
34.1 Titer
Interval 26.8 to 43.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 182
|
—
|
19.5 Titer
Interval 17.1 to 22.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 224
|
—
|
51.2 Titer
Interval 36.3 to 72.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 549
|
27.1 Titer
Interval 22.1 to 33.3
|
27.8 Titer
Interval 22.5 to 34.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 591
|
155.4 Titer
Interval 103.2 to 234.0
|
82.8 Titer
Interval 58.9 to 116.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 42
|
26.9 Percentage of subjects
Interval 11.6 to 47.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 224
|
—
|
42.9 Percentage of subjects
Interval 24.5 to 62.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 591
|
83.3 Percentage of subjects
Interval 62.6 to 95.3
|
55.0 Percentage of subjects
Interval 31.5 to 76.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 42
|
1.7 Ratio
Interval 1.1 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 224
|
—
|
2.6 Ratio
Interval 1.9 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 549
|
1.4 Ratio
Interval 1.0 to 1.8
|
1.3 Ratio
Interval 1.0 to 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 591
|
7.8 Ratio
Interval 4.7 to 12.9
|
4.0 Ratio
Interval 2.7 to 5.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12 + 21 days
|
100 Percentage of subjects
Interval 92.6 to 100.0
|
100 Percentage of subjects
Interval 92.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 Cohort
Day 0
|
20.0 Titer
Interval 17.2 to 23.2
|
18.9 Titer
Interval 17.0 to 21.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 Cohort
Day 21
|
40.5 Titer
Interval 32.7 to 50.2
|
44.8 Titer
Interval 36.4 to 55.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 Cohort
Month 12 + 21 days
|
146.7 Titer
Interval 108.3 to 198.9
|
256.5 Titer
Interval 181.6 to 362.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 Cohort
Day 21
|
34.0 Percentage of subjects
Interval 21.5 to 48.3
|
30.6 Percentage of subjects
Interval 18.3 to 45.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 Cohort
Month 12 + 21 days
|
77.1 Percentage of subjects
Interval 62.7 to 88.0
|
91.5 Percentage of subjects
Interval 79.6 to 97.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Day 21
|
2.0 Ratio
Interval 1.6 to 2.5
|
2.4 Ratio
Interval 1.9 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Month 12
|
1.5 Ratio
Interval 1.2 to 1.8
|
1.4 Ratio
Interval 1.2 to 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Month 12 + 21 days
|
7.1 Ratio
Interval 5.2 to 9.7
|
13.8 Ratio
Interval 9.6 to 19.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
Day 0
|
18.7 Titer
Interval 16.8 to 20.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
Day 21
|
22.4 Titer
Interval 20.4 to 24.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 0.0 to 11.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 1.1 to 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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 ).
Outcome measures
| Measure |
H5N1_PAS
n=28 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
96.3 Percentage of subjects
Interval 81.0 to 99.9
|
96.6 Percentage of subjects
Interval 82.2 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
100 Percentage of subjects
Interval 86.3 to 100.0
|
93.1 Percentage of subjects
Interval 77.2 to 99.2
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=28 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
15.6 Titer
Interval 12.5 to 19.5
|
24.6 Titer
Interval 15.9 to 38.0
|
24.8 Titer
Interval 17.7 to 34.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
338.2 Titer
Interval 257.5 to 444.4
|
78.1 Titer
Interval 48.6 to 125.6
|
87.7 Titer
Interval 65.9 to 116.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=24 Participants
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.
|
QPAN5_G
n=27 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 78.9 to 99.9
|
55.6 Percentage of subjects
Interval 35.3 to 74.5
|
55.2 Percentage of subjects
Interval 35.7 to 73.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=24 Participants
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.
|
QPAN5_G
n=27 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 14.7 to 31.1
|
3.0 Ratio
Interval 1.6 to 5.7
|
3.4 Ratio
Interval 2.5 to 4.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
100 Percentage of subjects
Interval 89.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
Day 0
|
18.8 Titer
Interval 13.3 to 26.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
Day 42
|
62.2 Titer
Interval 40.0 to 96.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 33.5 to 69.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 2.3 to 4.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
100 Percentage of subjects
Interval 86.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
—
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 224
|
—
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 549
|
100 Percentage of subjects
Interval 86.3 to 100.0
|
100 Percentage of subjects
Interval 83.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 591
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 0
|
20.5 Titer
Interval 15.5 to 27.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 42
|
68.2 Titer
Interval 42.0 to 110.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 182
|
—
|
19.1 Titer
Interval 14.7 to 24.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 224
|
—
|
78.0 Titer
Interval 53.2 to 114.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 549
|
42.3 Titer
Interval 29.2 to 61.1
|
47.2 Titer
Interval 30.9 to 72.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 591
|
84.8 Titer
Interval 57.7 to 124.6
|
77.3 Titer
Interval 55.9 to 106.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 42
|
65.4 Percentage of subjects
Interval 44.3 to 82.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 224
|
—
|
57.1 Percentage of subjects
Interval 37.2 to 75.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 591
|
62.5 Percentage of subjects
Interval 40.6 to 81.2
|
50.0 Percentage of subjects
Interval 27.2 to 72.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 42
|
3.3 Ratio
Interval 2.0 to 5.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 224
|
—
|
4.0 Ratio
Interval 2.5 to 6.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 549
|
2.1 Ratio
Interval 1.4 to 2.9
|
2.1 Ratio
Interval 1.5 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 591
|
4.0 Ratio
Interval 2.7 to 5.9
|
3.6 Ratio
Interval 2.3 to 5.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
98.0 Percentage of subjects
Interval 89.1 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
97.9 Percentage of subjects
Interval 88.7 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12 + 21 Days
|
100 Percentage of subjects
Interval 92.6 to 100.0
|
100 Percentage of subjects
Interval 92.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=49 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort
Day 0
|
20.0 Titer
Interval 15.9 to 25.2
|
18.4 Titer
Interval 14.4 to 23.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort
Day 21
|
75.9 Titer
Interval 59.9 to 96.2
|
94.1 Titer
Interval 68.4 to 129.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort
Month 12 + 21 Days
|
73.4 Titer
Interval 55.4 to 97.1
|
72.2 Titer
Interval 55.4 to 94.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=47 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort
Day 21
|
64.2 Percentage of subjects
Interval 49.8 to 76.9
|
70.2 Percentage of subjects
Interval 55.1 to 82.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort
Month 12 + 21 Days
|
52.1 Percentage of subjects
Interval 37.2 to 66.7
|
55.3 Percentage of subjects
Interval 40.1 to 69.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=48 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Day 21
|
3.8 Ratio
Interval 2.8 to 5.1
|
5.2 Ratio
Interval 3.9 to 7.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Month 12
|
1.3 Ratio
Interval 1.0 to 1.7
|
1.9 Ratio
Interval 1.5 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Month 12 + 21 Days
|
3.4 Ratio
Interval 2.5 to 4.7
|
4.2 Ratio
Interval 3.1 to 5.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
96.7 Percentage of subjects
Interval 82.8 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
Day 0
|
28.3 Titer
Interval 19.8 to 40.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
Day 21
|
118.9 Titer
Interval 88.4 to 159.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=28 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 37.2 to 75.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose1) compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=28 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 2.8 to 6.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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).
Outcome measures
| Measure |
H5N1_PAS
n=21 Participants
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.
|
QPAN5_G
n=23 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
100 Percentage of subjects
Interval 83.9 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
100 Percentage of subjects
Interval 88.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
100 Percentage of subjects
Interval 81.5 to 100.0
|
100 Percentage of subjects
Interval 85.2 to 100.0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=21 Participants
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.
|
QPAN5_G
n=23 Participants
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.
|
H5N1_AS
n=30 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
17.5 Titer
Interval 12.9 to 23.9
|
25.5 Titer
Interval 14.9 to 43.7
|
41.0 Titer
Interval 27.2 to 61.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
186.6 Titer
Interval 120.8 to 288.4
|
52.5 Titer
Interval 37.5 to 73.3
|
60.6 Titer
Interval 43.6 to 84.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=13 Participants
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.
|
QPAN5_G
n=19 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 54.6 to 98.1
|
42.1 Percentage of subjects
Interval 20.3 to 66.5
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=13 Participants
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.
|
QPAN5_G
n=19 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 5.7 to 17.2
|
1.9 Ratio
Interval 1.1 to 3.4
|
1.4 Ratio
Interval 1.2 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=32 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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)
Day 0
|
100 Percentage of subjects
Interval 88.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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)
Day 42
|
100 Percentage of subjects
Interval 89.1 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=32 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
Day 0
|
40.9 Titer
Interval 22.9 to 73.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)
Day 42
|
56.6 Titer
Interval 31.0 to 103.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 0.1 to 17.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 1.1 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
92.3 Percentage of subjects
Interval 74.9 to 99.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 42
|
96.2 Percentage of subjects
Interval 80.4 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 182
|
—
|
89.7 Percentage of subjects
Interval 72.6 to 97.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 224
|
—
|
96.4 Percentage of subjects
Interval 81.7 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 549
|
96.0 Percentage of subjects
Interval 79.6 to 99.9
|
100 Percentage of subjects
Interval 83.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 591
|
100 Percentage of subjects
Interval 85.8 to 100.0
|
100 Percentage of subjects
Interval 83.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 0
|
12.4 Titer
Interval 9.5 to 16.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 42
|
19.0 Titer
Interval 14.3 to 25.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 182
|
—
|
12.4 Titer
Interval 9.6 to 16.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 224
|
—
|
24.4 Titer
Interval 17.9 to 33.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 549
|
22.3 Titer
Interval 15.2 to 32.8
|
26.9 Titer
Interval 17.7 to 40.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort
Day 591
|
33.6 Titer
Interval 22.8 to 49.6
|
31.4 Titer
Interval 20.8 to 47.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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)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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 42
|
15.4 Percentage of subjects
Interval 4.4 to 34.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 224
|
—
|
25.0 Percentage of subjects
Interval 10.7 to 44.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort
Day 591
|
25.0 Percentage of subjects
Interval 9.8 to 46.7
|
35.0 Percentage of subjects
Interval 15.4 to 59.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
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 GPopulation: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=26 Participants
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.
|
QPAN5_G
n=28 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 42
|
1.5 Ratio
Interval 1.2 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 224
|
—
|
1.9 Ratio
Interval 1.5 to 2.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 549
|
1.8 Ratio
Interval 1.3 to 2.5
|
2.0 Ratio
Interval 1.5 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort
Day 591
|
2.6 Ratio
Interval 1.8 to 3.7
|
2.2 Ratio
Interval 1.6 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=48 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
96.2 Percentage of subjects
Interval 87.0 to 99.5
|
97.9 Percentage of subjects
Interval 88.9 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 93.3 to 100.0
|
100 Percentage of subjects
Interval 92.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Month 12 + 21 days
|
97.9 Percentage of subjects
Interval 88.9 to 99.9
|
97.9 Percentage of subjects
Interval 88.7 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=48 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort
Day 0
|
11.9 Titer
Interval 10.7 to 13.2
|
13.7 Titer
Interval 11.1 to 17.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort
Day 21
|
22.8 Titer
Interval 19.1 to 27.2
|
27.0 Titer
Interval 22.1 to 33.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort
Month 12 + 21 days
|
21.2 Titer
Interval 17.4 to 25.8
|
23.2 Titer
Interval 19.2 to 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=46 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort
Day 21
|
18.9 Percentage of subjects
Interval 9.4 to 32.0
|
26.7 Percentage of subjects
Interval 14.6 to 41.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort
Month 12 + 21 days
|
22.9 Percentage of subjects
Interval 12.0 to 37.3
|
21.7 Percentage of subjects
Interval 10.9 to 36.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=53 Participants
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.
|
QPAN5_G
n=47 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Day 21
|
1.9 Ratio
Interval 1.6 to 2.3
|
2.1 Ratio
Interval 1.6 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Month 12
|
1.2 Ratio
Interval 1.1 to 1.5
|
1.3 Ratio
Interval 1.0 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort
Month 12 + 21 days
|
1.8 Ratio
Interval 1.5 to 2.2
|
1.7 Ratio
Interval 1.3 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
Day 0
|
96.6 Percentage of subjects
Interval 82.2 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
Day 21
|
100 Percentage of subjects
Interval 87.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
Day 0
|
38.1 Titer
Interval 25.6 to 56.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort
Day 21
|
312.2 Titer
Interval 215.8 to 451.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=27 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Percentage of subjects
Interval 57.7 to 91.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At D21 (post-dose1) compared to D0Population: 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.
With respect to samples from HA Group 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.
Outcome measures
| Measure |
H5N1_PAS
n=27 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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 Ratio
Interval 5.0 to 13.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At D21, D42, and D182Population: 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.
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).
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 Cohort
Day 42
|
46177.1 EU/mL
Interval 37510.4 to 56846.2
|
38598.2 EU/mL
Interval 27818.0 to 53555.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 Cohort
Day 182
|
21782.4 EU/mL
Interval 17803.2 to 26651.0
|
24705.6 EU/mL
Interval 18369.2 to 33227.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 Cohort
Day 21
|
45098.3 EU/mL
Interval 34775.1 to 58486.2
|
37969.9 EU/mL
Interval 26930.8 to 53534.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At D21, D42, D182 and Day 385Population: 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.
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).
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=27 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 Cohort
Day 21
|
46013.8 EU/mL
Interval 33592.9 to 63027.5
|
27845.9 EU/mL
Interval 20269.3 to 38254.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 Cohort
Day 42
|
68348.8 EU/mL
Interval 53244.4 to 87738.1
|
31718.0 EU/mL
Interval 23755.4 to 42349.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 Cohort
Day 182
|
33610.2 EU/mL
Interval 26464.5 to 42685.3
|
17401.9 EU/mL
Interval 13330.1 to 22717.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 Cohort
Day 385
|
25346.9 EU/mL
Interval 20205.0 to 31797.3
|
15768.2 EU/mL
Interval 11999.3 to 20720.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At D21, D42 and D182Population: 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.
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).
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
QPAN5_G
n=30 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 Cohort
Day 21
|
25189.3 EU/mL
Interval 20983.6 to 30238.0
|
16592.8 EU/mL
Interval 13332.5 to 20650.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 Cohort
Day 42
|
31665.4 EU/mL
Interval 27405.9 to 36587.0
|
19681.1 EU/mL
Interval 16293.6 to 23772.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 Cohort
Day 182
|
20570.2 EU/mL
Interval 16717.6 to 25310.5
|
15471.1 EU/mL
Interval 11913.9 to 20090.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
H5N1_PAS
n=27 Participants
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.
|
QPAN5_G
n=25 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 Cohort
Day 21
|
63.0 Percentage of subjects
Interval 42.4 to 80.6
|
52.2 Percentage of subjects
Interval 30.6 to 73.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 Cohort
Day 42
|
72.0 Percentage of subjects
Interval 50.6 to 87.9
|
60.0 Percentage of subjects
Interval 38.7 to 78.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 Cohort
Day 182
|
25.9 Percentage of subjects
Interval 11.1 to 46.3
|
32.0 Percentage of subjects
Interval 14.9 to 53.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=27 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 Cohort
Day 21
|
34.5 Percentage of subjects
Interval 17.9 to 54.3
|
7.4 Percentage of subjects
Interval 0.9 to 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 Cohort
Day 42
|
55.2 Percentage of subjects
Interval 35.7 to 73.6
|
18.5 Percentage of subjects
Interval 6.3 to 38.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 Cohort
Day 182
|
13.8 Percentage of subjects
Interval 3.9 to 31.7
|
7.4 Percentage of subjects
Interval 0.9 to 24.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 Cohort
Day 385
|
6.9 Percentage of subjects
Interval 0.8 to 22.8
|
0.0 Percentage of subjects
Interval 0.0 to 12.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
QPAN5_G
n=30 Participants
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 Cohort
Day 21
|
10.0 Percentage of subjects
Interval 2.1 to 26.5
|
6.7 Percentage of subjects
Interval 0.8 to 22.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 Cohort
Day 42
|
20.0 Percentage of subjects
Interval 7.7 to 38.6
|
3.3 Percentage of subjects
Interval 0.1 to 17.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 Cohort
Day 182
|
3.6 Percentage of subjects
Interval 0.1 to 18.3
|
3.3 Percentage of subjects
Interval 0.1 to 17.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0Population: 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.
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).
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
H5N1_NAS
n=27 Participants
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
|
H9N2_AS
n=30 Participants
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.
|
H9N2_NAS
n=30 Participants
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
17 Participants
|
19 Participants
|
20 Participants
|
26 Participants
|
19 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
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
Seropositive
|
12 Participants
|
10 Participants
|
9 Participants
|
1 Participants
|
11 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
H5N1_PAS
n=30 Participants
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.
|
QPAN5_G
n=26 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
H5N1_NAS
n=53 Participants
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
|
H9N2_AS
n=49 Participants
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
A/Christchurch/16/2010-seronegative
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Christchurch/16/2010-seropositive
|
27 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Christchurch/16/2010-missing
|
0 Participants
|
26 Participants
|
29 Participants
|
53 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Indonesia/5/2005-seronegative
|
0 Participants
|
26 Participants
|
0 Participants
|
0 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Indonesia/5/2005-seropositive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Indonesia/5/2005-missing
|
30 Participants
|
0 Participants
|
29 Participants
|
53 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Turkey/01/2005-seronegative
|
0 Participants
|
25 Participants
|
24 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Turkey/01/2005-seropositive
|
0 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Turkey/01/2005-missing
|
30 Participants
|
0 Participants
|
0 Participants
|
53 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Vietnam/1194/2004-like-seronegative
|
0 Participants
|
0 Participants
|
0 Participants
|
52 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Vietnam/1194/2004-like-seropositive
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
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
A/Vietnam/1194/2004-like-missing
|
30 Participants
|
26 Participants
|
29 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0Population: 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.
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).
Outcome measures
| Measure |
H5N1_PAS
n=29 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_AS
n=29 Participants
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
|
H5N1_NAS
n=27 Participants
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
|
H9N2_AS
n=30 Participants
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.
|
H9N2_NAS
n=30 Participants
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.
|
QPAN5_C
n=26 Participants
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.
|
QPAN5_G
n=29 Participants
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.
|
H5N1_VT
n=53 Participants
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.
|
H5N1_IN
n=49 Participants
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
17 Participants
|
19 Participants
|
7 Participants
|
9 Participants
|
4 Participants
|
7 Participants
|
16 Participants
|
15 Participants
|
31 Participants
|
32 Participants
|
|
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
Seropositive
|
12 Participants
|
10 Participants
|
21 Participants
|
18 Participants
|
26 Participants
|
23 Participants
|
10 Participants
|
14 Participants
|
19 Participants
|
15 Participants
|
|
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
Missing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 0Population: 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.
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.
Outcome measures
| Measure |
H5N1_PAS
n=33 Participants
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.
|
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.
|
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
|
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
|
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.
|
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.
|
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.
|
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.
|
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.
|
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
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Seropositivity Status Against Flu A/Indonesia/05/2005 (H5N1) HI Antibodies - Pediatric H5N1 Cohort
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
H1N1_AS
H1N1_NAS
H5N1_AS
H5N1_NAS
H9N2_AS
H9N2_NAS
DQIV_NAS
QPAN5_C
QPAN5_G
H5N1_VT
H5N1_IN
H5N1_PAS
H5N1_PCN
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER