Trial Outcomes & Findings for H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses (NCT NCT02921997)
NCT ID: NCT02921997
Last Updated: 2024-10-09
Results Overview
Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer =\>1:40 or a pre-vaccination HAI titer =\>1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer. Venous blood samples for serum were used for this assay. HAI based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Day 29 Post-Vaccination 2 (Day 57)
Results posted on
2024-10-09
Participant Flow
Participants were healthy males and non-pregnant females aged 18 to 49 years old, inclusively. They were recruited from the community at large around the clinic site. Participants were enrolled between 07NOV2016 and 31JAN2017.
Participant milestones
| Measure |
A/H3N2v
One dose of 15 ug of A/H3N2v at Day 1
A/H3N2v influenza virus vaccine: Monovalent inactivated influenza A/H3N2v virus vaccine (A/Minnesota/11/2010)
|
A/H7N9 + AS03
Two doses of 3.75 ug of A/H7N9 + AS03, at Day 1 and Day 29 (+/- 2 days)
AS03: AS03 oil-in-water emulsion adjuvant.
A/H7N9 influenza virus vaccine: Monovalent inactivated influenza A/H7N9 virus vaccine (A/Shanghai/2/2013)
|
A/H7N9
Two doses of 3.75 ug of A/H7N9, at Day 1 and Day 29 (+/- 2 days)
A/H7N9 influenza virus vaccine: Monovalent inactivated influenza A/H7N9 virus vaccine (A/Shanghai/2/2013)
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses
Baseline characteristics by cohort
| Measure |
A/H3N2v
n=10 Participants
One dose of 15 ug of A/H3N2v, at Day 1 A/H3N2v influenza virus vaccine: Monovalent inactivated influenza A/H3N2v virus vaccine (A/Minnesota/11/2010).
|
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of A/H7N9 + AS03, at Day 1 and Day 29 (+/- 2 days) AS03: AS03 oil-in-water emulsion adjuvant. A/H7N9 influenza virus vaccine: Monovalent inactivated influenza A/H7N9 virus vaccine (A/Shanghai/2/2013)
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of A/H7N9, at Day 1 and Day 29 (+/- 2 days) A/H7N9 influenza virus vaccine: Monovalent inactivated influenza A/H7N9 virus vaccine (A/Shanghai/2/2013)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 7.1 • n=99 Participants
|
28.0 years
STANDARD_DEVIATION 6.2 • n=107 Participants
|
33.7 years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
30.9 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
30 participants
n=7 Participants
|
|
BMI
|
24.125 kg/m^2
STANDARD_DEVIATION 5.609 • n=99 Participants
|
21.885 kg/m^2
STANDARD_DEVIATION 2.520 • n=107 Participants
|
28.453 kg/m^2
STANDARD_DEVIATION 10.768 • n=206 Participants
|
24.821 kg/m^2
STANDARD_DEVIATION 7.443 • n=7 Participants
|
PRIMARY outcome
Timeframe: Day 29 Post-Vaccination 2 (Day 57)Population: The intent-to-treat (ITT) population, A/H7N9 + AS03 and A/H7N9 arms: Includes all participants in the A/H7N9 + AS03 and A/H7N9 arms who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported.
Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer =\>1:40 or a pre-vaccination HAI titer =\>1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer. Venous blood samples for serum were used for this assay. HAI based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H7N9 Vaccine, With and Without Adjuvant)
|
80.0 percentage of participants
Interval 44.4 to 97.5
|
0 percentage of participants
Interval 0.0 to 30.8
|
—
|
PRIMARY outcome
Timeframe: Day 29 Post-Vaccination 1 (Day 29)Population: The intent-to-treat (ITT) population, A/H3N2v arm: Includes all participants in the A/H3N2v arm who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported.
Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer =\>1:40 or a pre-vaccination HAI titer =\>1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer. Venous blood samples for serum were used for this assay. HAI based on the H3N2 strain A/Minnesota/11/2010 were assessed.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion Based on HAI Titer (A/H3N2v Vaccine)
|
50 percentage of participants
Interval 18.7 to 81.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 2, 4, and 29 Post-Vaccination 1 (Day 2, 4, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)Population: The transcriptomics analysis population, A/H7N9 + AS03 and A/H7N9 arms: Includes all participants in the A/H7N9 +AS03 and A/H7N9 arms who received at least one study vaccination and contributed at least one pre- and one post-vaccination sample for transcriptomics testing for which valid results were reported.
RNA expression levels (read counts) for each gene were determined by RNA-Sequencing of RNA extracted from six separated cell types: monocytes , dendritic cells, neutrophils, NK cells, B cells, and T cells. Post-vaccination gene expression levels were compared to pre-vaccination gene expression levels (combined summed read counts for Day -7 and Day 1 samples for post-vaccination 1 timepoints and Day 29 read counts for post-vaccination 2 timepoints) using a negative binomial model to identify differentially expressed (DE) genes (FDR-adjusted p-value \< 0.05 and mean fold change =\> 1.5 in either direction).
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
NK cells : Day 2 Post Vaccination 1
|
60 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
NK cells : Day 4 Post Vaccination 2
|
396 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Monocytes : Day 29 Post Vaccination 1
|
0 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Neutrophils : Day 4 Post Vaccination 1
|
41 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Neutrophils : Day 29 Post Vaccination 1
|
0 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Monocytes : Day 2 Post Vaccination 1
|
618 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Monocytes : Day 4 Post Vaccination 1
|
36 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Monocytes : Day 2 Post Vaccination 2
|
1418 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Monocytes : Day 4 Post Vaccination 2
|
26 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Monocytes : Day 8 Post Vaccination 2
|
4 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Dendritic cells : Day 2 Post Vaccination 1
|
1091 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Dendritic cells : Day 4 Post Vaccination 1
|
8 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Dendritic cells : Day 29 Post Vaccination 1
|
1 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Dendritic cells : Day 2 Post Vaccination 2
|
1953 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Dendritic cells : Day 4 Post Vaccination 2
|
25 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Dendritic cells : Day 8 Post Vaccination 2
|
170 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Neutrophils : Day 2 Post Vaccination 1
|
1116 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Neutrophils : Day 2 Post Vaccination 2
|
2044 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Neutrophils : Day 4 Post Vaccination 2
|
181 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
Neutrophils : Day 8 Post Vaccination 2
|
0 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
NK cells : Day 4 Post Vaccination 1
|
66 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
NK cells : Day 29 Post Vaccination 1
|
8 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
NK cells : Day 2 Post Vaccination 2
|
303 Number of DE genes
|
2 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
NK cells : Day 8 Post Vaccination 2
|
166 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
B cells : Day 2 Post Vaccination 1
|
51 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
B cells : Day 4 Post Vaccination 1
|
1 Number of DE genes
|
1 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
B cells : Day 29 Post Vaccination 1
|
1 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
B cells : Day 2 Post Vaccination 2
|
345 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
B cells : Day 4 Post Vaccination 2
|
99 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
B cells : Day 8 Post Vaccination 2
|
67 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
T cells : Day 2 Post Vaccination 1
|
88 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
T cells : Day 4 Post Vaccination 1
|
0 Number of DE genes
|
1 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
T cells : Day 29 Post Vaccination 1
|
1 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
T cells : Day 2 Post Vaccination 2
|
301 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
T cells : Day 4 Post Vaccination 2
|
3 Number of DE genes
|
0 Number of DE genes
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H7N9 Vaccine, With and Without Adjuvant)
T cells : Day 8 Post Vaccination 2
|
3 Number of DE genes
|
0 Number of DE genes
|
—
|
SECONDARY outcome
Timeframe: Days 2, 4, and 8 Post-Vaccination 1 (Day 2, 4, and 8, respectively)Population: The transcriptomics analysis population A/H3N2v arm: Includes all participants in the A/H3N2v arm who received at least one study vaccination and contributed at least one pre- and one post vaccination sample for transcriptomics testing for which valid results were reported.
RNA expression levels (read counts) for each gene were determined by RNA-Sequencing of RNA extracted from six separated cell types: monocytes, dendritic cells, neutrophils, NK cells, B cells, and T cells. Post-vaccination gene expression levels were compared to pre-vaccination gene expression levels (combined summed read counts for Day -7 and Day 1 samples for post-vaccination 1 timepoints) using a negative binomial model to identify differentially expressed (DE) genes (FDR-adjusted p-value \< 0.05 and mean fold change =\> 1.5 in either direction).
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
Monocytes : Day 2 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
Monocytes : Day 4 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
Monocytes : Day 8 Post Vaccination 1
|
1 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
Dendritic cells : Day 2 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
Dendritic cells : Day 4 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
Dendritic cells : Day 8 Post Vaccination 1
|
2 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
Neutrophils : Day 2 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
Neutrophils : Day 4 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
Neutrophils : Day 8 Post Vaccination 1
|
41 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
NK cells : Day 2 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
NK cells : Day 4 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
NK cells : Day 8 Post Vaccination 1
|
1 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
B cells : Day 2 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
B cells : Day 4 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
B cells : Day 8 Post Vaccination 1
|
3 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
T cells : Day 2 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
T cells : Day 4 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
|
Number of Differentially Expressed Genes Based on RNA Expression in Human Immune Cells (A/H3N2v Vaccine)
T cells : Day 8 Post Vaccination 1
|
0 Number of DE genes
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Vaccination 1; Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)Population: The intent-to-treat (ITT) population: Includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported.
Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 11 of the total 24 cytokines and chemokines were measured: Fractalkine, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), Interferon-Gamma-Induced Protein-10(IP-10), Interferon-Alpha (IFNa), Interferon-Beta (IFNb), Interferon-Gamma (IFNy), Interferon-inducible T Cell Alpha Chemoattractant (ITAC), Interleukin 1 Beta (IL-1b), Interleukin 10 (IL-10), Interleukin 13 (IL-13), and Interleukin 2 (IL-2). If no cytokine or chemokine measurements were collected, number of participants is reported as 0.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-2 : Day 4 Post-Vaccination 1
|
3.43 ng/L
Interval 2.03 to 6.49
|
2.28 ng/L
Interval 1.74 to 7.0
|
3.82 ng/L
Interval 2.98 to 7.79
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
Fractalkine : Day 8 Post-Vaccination 1
|
370.77 ng/L
Interval 204.33 to 783.22
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
GM-CSF : Day 1 Pre-Vaccination
|
511.59 ng/L
Interval 322.67 to 819.37
|
290.44 ng/L
Interval 188.18 to 447.68
|
478.50 ng/L
Interval 320.57 to 837.17
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IP-10 : Day 2 Post-Vaccination 1
|
261.78 ng/L
Interval 229.52 to 621.71
|
535.80 ng/L
Interval 372.78 to 709.82
|
273.48 ng/L
Interval 137.01 to 362.69
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IP-10 : Day 29 Post-Vaccination 1
|
—
|
284.62 ng/L
Interval 200.09 to 367.84
|
212.26 ng/L
Interval 144.78 to 259.6
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IP-10 : Day 2 Post-Vaccination 2
|
—
|
1264.00 ng/L
Interval 586.12 to 2541.12
|
234.75 ng/L
Interval 134.66 to 311.02
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNa : Day 8 Post-Vaccination 2
|
—
|
163.86 ng/L
Interval 102.5 to 219.7
|
89.00 ng/L
Interval 26.83 to 168.33
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNy : Day 4 Post-Vaccination 2
|
—
|
19.99 ng/L
Interval 10.9 to 41.65
|
29.70 ng/L
Interval 22.16 to 39.11
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-10 : Day 2 Post-Vaccination 1
|
22.26 ng/L
Interval 10.43 to 65.61
|
17.16 ng/L
Interval 13.04 to 38.18
|
26.04 ng/L
Interval 21.0 to 36.63
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-13 : Day 4 Post-Vaccination 2
|
—
|
17.56 ng/L
Interval 11.01 to 35.15
|
10.08 ng/L
Interval 6.55 to 20.46
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-2 : Day 2 Post-Vaccination 1
|
4.13 ng/L
Interval 1.94 to 6.52
|
2.52 ng/L
Interval 1.2 to 6.57
|
4.32 ng/L
Interval 2.77 to 8.76
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
Fractalkine : Day 1 Pre-Vaccination
|
310.9 ng/L
Interval 184.35 to 624.88
|
288.58 ng/L
Interval 177.74 to 489.88
|
356.19 ng/L
Interval 247.36 to 435.4
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
Fractalkine : Day 2 Post-Vaccination 1
|
312.26 ng/L
Interval 201.01 to 590.01
|
224.58 ng/L
Interval 181.26 to 530.97
|
315.31 ng/L
Interval 218.69 to 514.56
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
Fractalkine : Day 4 Post-Vaccination 1
|
345.14 ng/L
Interval 218.03 to 567.98
|
378.46 ng/L
Interval 172.26 to 543.87
|
309.48 ng/L
Interval 212.57 to 494.9
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
Fractalkine : Day 29 Post-Vaccination 1
|
—
|
353.48 ng/L
Interval 210.9 to 492.3
|
333.38 ng/L
Interval 265.87 to 450.44
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
Fractalkine : Day 2 Post-Vaccination 2
|
—
|
282.53 ng/L
Interval 178.94 to 566.01
|
305.83 ng/L
Interval 235.42 to 476.17
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
Fractalkine : Day 4 Post-Vaccination 2
|
—
|
311.15 ng/L
Interval 223.31 to 466.89
|
316.25 ng/L
Interval 235.51 to 461.43
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
Fractalkine : Day 8 Post-Vaccination 2
|
—
|
318.38 ng/L
Interval 178.94 to 486.64
|
306.53 ng/L
Interval 209.59 to 449.82
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
GM-CSF : Day 2 Post-Vaccination 1
|
557.77 ng/L
Interval 354.92 to 783.59
|
301.31 ng/L
Interval 195.59 to 423.36
|
478.66 ng/L
Interval 327.51 to 713.41
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
GM-CSF : Day 4 Post-Vaccination 1
|
561.63 ng/L
Interval 311.31 to 787.86
|
286.35 ng/L
Interval 171.87 to 477.21
|
448.62 ng/L
Interval 329.53 to 722.5
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
GM-CSF : Day 8 Post-Vaccination 1
|
494.07 ng/L
Interval 238.89 to 778.82
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
GM-CSF : Day 29 Post-Vaccination 1
|
—
|
324.61 ng/L
Interval 192.61 to 392.17
|
476.40 ng/L
Interval 315.83 to 832.99
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
GM-CSF : Day 2 Post-Vaccination 2
|
—
|
313.25 ng/L
Interval 225.34 to 442.63
|
497.90 ng/L
Interval 301.38 to 809.71
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
GM-CSF : Day 4 Post-Vaccination 2
|
—
|
259.34 ng/L
Interval 210.99 to 385.57
|
468.16 ng/L
Interval 344.33 to 920.82
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
GM-CSF : Day 8 Post-Vaccination 2
|
—
|
276.04 ng/L
Interval 195.2 to 452.95
|
468.95 ng/L
Interval 330.08 to 612.07
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IP-10 : Day 1 Pre-Vaccination
|
249.16 ng/L
Interval 209.78 to 360.45
|
288.09 ng/L
Interval 194.27 to 444.35
|
238.80 ng/L
Interval 157.18 to 324.89
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IP-10 : Day 4 Post-Vaccination 1
|
242.77 ng/L
Interval 198.72 to 376.06
|
417.82 ng/L
Interval 263.11 to 560.03
|
219.79 ng/L
Interval 161.22 to 381.36
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IP-10 : Day 8 Post-Vaccination 1
|
236.95 ng/L
Interval 175.75 to 315.67
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IP-10 : Day 4 Post-Vaccination 2
|
—
|
512.16 ng/L
Interval 339.91 to 567.27
|
224.40 ng/L
Interval 154.65 to 322.71
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IP-10 : Day 8 Post-Vaccination 2
|
—
|
307.23 ng/L
Interval 227.78 to 373.61
|
220.60 ng/L
Interval 127.68 to 280.31
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNa : Day 1 Pre-Vaccination
|
116.80 ng/L
Interval 58.27 to 149.96
|
142.43 ng/L
Interval 91.5 to 213.19
|
104.81 ng/L
Interval 64.58 to 152.56
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNa : Day 2 Post-Vaccination 1
|
73.98 ng/L
Interval 62.82 to 155.25
|
132.03 ng/L
Interval 91.88 to 179.71
|
101.40 ng/L
Interval 38.58 to 232.97
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNa : Day 4 Post-Vaccination 1
|
66.93 ng/L
Interval 30.39 to 191.17
|
125.29 ng/L
Interval 87.21 to 251.48
|
86.82 ng/L
Interval 29.6 to 181.88
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNa : Day 8 Post-Vaccination 1
|
89.29 ng/L
Interval 51.11 to 153.41
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNa : Day 29 Post-Vaccination 1
|
—
|
118.90 ng/L
Interval 79.39 to 218.86
|
111.00 ng/L
Interval 53.91 to 149.95
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNa : Day 2 Post-Vaccination 2
|
—
|
130.25 ng/L
Interval 97.22 to 213.06
|
89.99 ng/L
Interval 38.72 to 161.13
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNa : Day 4 Post-Vaccination 2
|
—
|
127.23 ng/L
Interval 93.43 to 231.92
|
113.26 ng/L
Interval 51.8 to 225.69
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNb : Day 1 Pre-Vaccination
|
1073.70 ng/L
Interval 856.91 to 1843.25
|
1211.25 ng/L
Interval 743.26 to 1686.5
|
989.57 ng/L
Interval 760.7 to 1818.92
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNb : Day 2 Post-Vaccination 1
|
1023.11 ng/L
Interval 732.33 to 1286.0
|
1068.38 ng/L
Interval 708.26 to 1620.5
|
1106.50 ng/L
Interval 657.21 to 1516.84
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNb : Day 4 Post-Vaccination 1
|
878.76 ng/L
Interval 735.36 to 1534.5
|
1074.52 ng/L
Interval 739.07 to 1730.0
|
1045.50 ng/L
Interval 867.77 to 1768.0
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNb : Day 8 Post-Vaccination 1
|
1104.00 ng/L
Interval 718.5 to 1564.0
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNb : Day 29 Post-Vaccination 1
|
—
|
1185.00 ng/L
Interval 598.46 to 1407.5
|
1109.00 ng/L
Interval 684.26 to 2134.0
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNb : Day 2 Post-Vaccination 2
|
—
|
1188.50 ng/L
Interval 734.74 to 1757.0
|
1241.50 ng/L
Interval 624.16 to 1883.74
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNb : Day 4 Post-Vaccination 2
|
—
|
1027.74 ng/L
Interval 649.67 to 1760.0
|
980.99 ng/L
Interval 776.21 to 1564.0
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNb : Day 8 Post-Vaccination 2
|
—
|
992.82 ng/L
Interval 647.85 to 1671.5
|
1326.50 ng/L
Interval 776.4 to 1521.25
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNy : Day 1 Pre-Vaccination
|
28.71 ng/L
Interval 13.21 to 46.65
|
17.86 ng/L
Interval 11.28 to 43.92
|
33.82 ng/L
Interval 22.85 to 45.92
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNy : Day 2 Post-Vaccination 1
|
26.47 ng/L
Interval 12.49 to 54.72
|
21.22 ng/L
Interval 13.01 to 47.81
|
33.17 ng/L
Interval 22.11 to 46.45
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNy : Day 4 Post-Vaccination 1
|
26.38 ng/L
Interval 14.2 to 50.92
|
19.01 ng/L
Interval 9.02 to 47.74
|
33.74 ng/L
Interval 22.81 to 41.58
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNy : Day 8 Post-Vaccination 1
|
30.98 ng/L
Interval 13.45 to 48.7
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNy : Day 29 Post-Vaccination 1
|
—
|
23.07 ng/L
Interval 11.57 to 49.17
|
32.43 ng/L
Interval 25.74 to 39.04
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNy : Day 2 Post-Vaccination 2
|
—
|
37.22 ng/L
Interval 23.07 to 59.78
|
30.79 ng/L
Interval 25.01 to 36.4
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IFNy : Day 8 Post-Vaccination 2
|
—
|
18.00 ng/L
Interval 11.37 to 46.89
|
28.94 ng/L
Interval 21.79 to 36.99
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
ITAC : Day 1 Pre-Vaccination
|
58.19 ng/L
Interval 27.49 to 140.69
|
44.19 ng/L
Interval 30.64 to 76.83
|
52.62 ng/L
Interval 26.89 to 89.05
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
ITAC : Day 2 Post-Vaccination 1
|
56.31 ng/L
Interval 27.66 to 152.1
|
52.46 ng/L
Interval 35.9 to 90.02
|
49.22 ng/L
Interval 30.06 to 75.22
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
ITAC : Day 4 Post-Vaccination 1
|
51.68 ng/L
Interval 23.65 to 188.54
|
47.38 ng/L
Interval 36.63 to 84.94
|
52.83 ng/L
Interval 24.25 to 69.46
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
ITAC : Day 8 Post-Vaccination 1
|
49.21 ng/L
Interval 20.12 to 205.3
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
ITAC : Day 29 Post-Vaccination 1
|
—
|
60.62 ng/L
Interval 23.95 to 86.14
|
49.58 ng/L
Interval 24.37 to 68.83
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
ITAC : Day 2 Post-Vaccination 2
|
—
|
77.16 ng/L
Interval 48.46 to 191.11
|
45.04 ng/L
Interval 23.91 to 68.24
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
ITAC : Day 4 Post-Vaccination 2
|
—
|
58.32 ng/L
Interval 31.86 to 83.67
|
34.97 ng/L
Interval 24.36 to 59.44
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
ITAC : Day 8 Post-Vaccination 2
|
—
|
50.94 ng/L
Interval 36.37 to 84.45
|
47.67 ng/L
Interval 28.41 to 76.88
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-1b : Day 1 Pre-Vaccination
|
2.84 ng/L
Interval 1.75 to 4.74
|
2.83 ng/L
Interval 1.43 to 5.08
|
3.33 ng/L
Interval 2.1 to 6.93
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-1b : Day 2 Post-Vaccination 1
|
2.62 ng/L
Interval 1.68 to 4.57
|
2.33 ng/L
Interval 1.3 to 5.28
|
3.46 ng/L
Interval 2.22 to 7.0
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-1b : Day 4 Post-Vaccination 1
|
2.78 ng/L
Interval 1.81 to 4.46
|
3.46 ng/L
Interval 1.34 to 5.8
|
3.39 ng/L
Interval 2.08 to 5.58
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-1b : Day 8 Post-Vaccination 1
|
2.82 ng/L
Interval 1.78 to 5.41
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-1b : Day 29 Post-Vaccination 1
|
—
|
3.25 ng/L
Interval 1.67 to 5.49
|
3.70 ng/L
Interval 2.25 to 5.03
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-1b : Day 2 Post-Vaccination 2
|
—
|
2.99 ng/L
Interval 1.37 to 7.12
|
3.88 ng/L
Interval 2.12 to 5.63
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-1b : Day 4 Post-Vaccination 2
|
—
|
2.81 ng/L
Interval 1.49 to 4.93
|
3.16 ng/L
Interval 2.25 to 6.93
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-1b : Day 8 Post-Vaccination 2
|
—
|
2.52 ng/L
Interval 1.59 to 7.03
|
3.03 ng/L
Interval 2.15 to 5.2
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-10 : Day 1 Pre-Vaccination
|
21.92 ng/L
Interval 9.32 to 59.45
|
18.28 ng/L
Interval 10.29 to 37.48
|
27.67 ng/L
Interval 19.96 to 40.21
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-10 : Day 4 Post-Vaccination 1
|
22.29 ng/L
Interval 15.03 to 72.99
|
17.64 ng/L
Interval 12.84 to 39.04
|
29.53 ng/L
Interval 20.68 to 41.65
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-10 : Day 8 Post-Vaccination 1
|
19.52 ng/L
Interval 12.57 to 105.24
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-10 : Day 29 Post-Vaccination 1
|
—
|
19.93 ng/L
Interval 12.35 to 38.28
|
26.71 ng/L
Interval 21.28 to 36.63
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-10 : Day 2 Post-Vaccination 2
|
—
|
23.79 ng/L
Interval 11.07 to 44.81
|
24.57 ng/L
Interval 17.44 to 35.06
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-10 : Day 4 Post-Vaccination 2
|
—
|
19.29 ng/L
Interval 14.95 to 36.55
|
26.39 ng/L
Interval 17.73 to 38.52
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-10 : Day 8 Post-Vaccination 2
|
—
|
21.75 ng/L
Interval 12.06 to 35.99
|
23.29 ng/L
Interval 19.25 to 31.83
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-13 : Day 1 Pre-Vaccination
|
11.24 ng/L
Interval 6.18 to 33.79
|
18.39 ng/L
Interval 8.41 to 28.27
|
12.46 ng/L
Interval 8.35 to 21.16
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-13 : Day 2 Post-Vaccination 1
|
10.98 ng/L
Interval 6.97 to 39.49
|
20.66 ng/L
Interval 8.93 to 25.85
|
11.72 ng/L
Interval 8.01 to 23.73
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-13 : Day 4 Post-Vaccination 1
|
13.86 ng/L
Interval 6.33 to 39.49
|
21.10 ng/L
Interval 9.03 to 25.98
|
11.51 ng/L
Interval 7.94 to 22.8
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-13 : Day 8 Post-Vaccination 1
|
11.02 ng/L
Interval 5.48 to 61.06
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-13 : Day 29 Post-Vaccination 1
|
—
|
19.35 ng/L
Interval 10.85 to 33.12
|
10.80 ng/L
Interval 5.79 to 21.52
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-13 : Day 2 Post-Vaccination 2
|
—
|
18.99 ng/L
Interval 9.84 to 36.55
|
10.79 ng/L
Interval 6.4 to 20.43
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-13 : Day 8 Post-Vaccination 2
|
—
|
21.50 ng/L
Interval 8.16 to 39.16
|
10.36 ng/L
Interval 7.25 to 21.45
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-2 : Day 1 Pre-Vaccination
|
3.30 ng/L
Interval 2.02 to 6.67
|
2.49 ng/L
Interval 1.33 to 6.58
|
4.48 ng/L
Interval 2.73 to 8.18
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-2 : Day 8 Post-Vaccination 1
|
2.99 ng/L
Interval 2.62 to 7.74
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-2 : Day 29 Post-Vaccination 1
|
—
|
2.29 ng/L
Interval 1.77 to 7.4
|
4.68 ng/L
Interval 3.08 to 6.97
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-2 : Day 2 Post-Vaccination 2
|
—
|
2.39 ng/L
Interval 1.17 to 8.47
|
4.05 ng/L
Interval 2.64 to 8.21
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-2 : Day 4 Post-Vaccination 2
|
—
|
2.71 ng/L
Interval 1.46 to 6.85
|
3.74 ng/L
Interval 2.69 to 9.81
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 1
IL-2 : Day 8 Post-Vaccination 2
|
—
|
3.14 ng/L
Interval 1.7 to 6.84
|
3.97 ng/L
Interval 2.69 to 6.22
|
SECONDARY outcome
Timeframe: Day 1 Pre-Vaccination 1; Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)Population: The intent-to-treat (ITT) population: Includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported. No cytokine or chemokine measurements were collected for the A/H3N2v arm after Day 8 Post-Vaccination 1 (Day 8), and for the A/H7N9 + AS03 and A/H7N9 arms at Day 8 Post-Vaccination 1 (Day 8).
Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 9 of the total 24 cytokines and chemokines were measured: Interleukin 21 (IL-21), Interleukin 23 (IL-23), Interleukin 4 (IL-4), Interleukin 5 (IL-5), Interleukin 6 (IL-6), Interleukin 7 (IL-7), Interleukin 8 (IL-8), Interleukin 12, p70 (IL-12p70), and Interleukin 17A (IL-17A). If no cytokine or chemokine measurements were collected, number of participants is reported as 0.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-6 : Day 4 Post-Vaccination 1
|
2.09 ng/L
Interval 1.21 to 5.42
|
1.48 ng/L
Interval 0.72 to 4.23
|
3.39 ng/L
Interval 2.25 to 6.85
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-7 : Day 1 Pre-Vaccination
|
4.02 ng/L
Interval 2.5 to 8.88
|
4.58 ng/L
Interval 2.27 to 10.37
|
5.22 ng/L
Interval 3.62 to 10.88
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-21 : Day 1 Pre-Vaccination
|
3.54 ng/L
Interval 1.39 to 9.12
|
3.25 ng/L
Interval 1.64 to 4.33
|
2.43 ng/L
Interval 1.66 to 10.32
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-21 : Day 2 Post-Vaccination 1
|
3.83 ng/L
Interval 1.56 to 10.25
|
3.00 ng/L
Interval 1.76 to 5.34
|
2.63 ng/L
Interval 1.76 to 9.32
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-21 : Day 4 Post-Vaccination 1
|
4.47 ng/L
Interval 1.92 to 11.57
|
2.76 ng/L
Interval 1.9 to 5.22
|
2.64 ng/L
Interval 1.76 to 9.26
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-21 : Day 8 Post-Vaccination 1
|
2.76 ng/L
Interval 1.12 to 15.81
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-21 : Day 29 Post-Vaccination 1
|
—
|
4.76 ng/L
Interval 1.9 to 5.77
|
2.53 ng/L
Interval 1.73 to 9.57
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-21 : Day 2 Post-Vaccination 2
|
—
|
4.29 ng/L
Interval 2.13 to 6.54
|
2.09 ng/L
Interval 1.38 to 9.3
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-21 : Day 4 Post-Vaccination 2
|
—
|
3.96 ng/L
Interval 1.96 to 5.91
|
2.01 ng/L
Interval 1.59 to 10.27
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-21 : Day 8 Post-Vaccination 2
|
—
|
2.85 ng/L
Interval 1.84 to 6.78
|
1.93 ng/L
Interval 1.71 to 7.32
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-23 : Day 1 Pre-Vaccination
|
367.05 ng/L
Interval 245.03 to 565.32
|
368.23 ng/L
Interval 280.19 to 527.92
|
550.19 ng/L
Interval 340.63 to 750.07
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-23 : Day 2 Post-Vaccination 1
|
304.56 ng/L
Interval 213.42 to 482.68
|
362.33 ng/L
Interval 199.2 to 495.74
|
490.16 ng/L
Interval 336.64 to 807.72
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-23 : Day 4 Post-Vaccination 1
|
419.28 ng/L
Interval 222.3 to 569.42
|
468.30 ng/L
Interval 246.74 to 605.22
|
583.59 ng/L
Interval 328.03 to 786.52
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-23 : Day 8 Post-Vaccination 1
|
339.06 ng/L
Interval 256.69 to 555.18
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-23 : Day 29 Post-Vaccination 1
|
—
|
418.57 ng/L
Interval 311.36 to 548.07
|
496.08 ng/L
Interval 317.22 to 918.63
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-23 : Day 2 Post-Vaccination 2
|
—
|
487.09 ng/L
Interval 312.55 to 758.84
|
536.87 ng/L
Interval 345.26 to 768.3
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-23 : Day 4 Post-Vaccination 2
|
—
|
409.82 ng/L
Interval 319.81 to 524.89
|
514.30 ng/L
Interval 310.06 to 768.41
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-23 : Day 8 Post-Vaccination 2
|
—
|
421.69 ng/L
Interval 326.56 to 622.45
|
444.43 ng/L
Interval 341.61 to 916.35
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-4 : Day 1 Pre-Vaccination
|
61.67 ng/L
Interval 48.37 to 103.08
|
49.85 ng/L
Interval 39.7 to 119.83
|
59.30 ng/L
Interval 46.83 to 154.39
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-4 : Day 2 Post-Vaccination 1
|
69.57 ng/L
Interval 43.44 to 105.29
|
53.00 ng/L
Interval 36.3 to 123.64
|
63.35 ng/L
Interval 45.19 to 188.85
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-4 : Day 4 Post-Vaccination 1
|
68.54 ng/L
Interval 50.44 to 91.18
|
53.75 ng/L
Interval 37.06 to 128.56
|
58.21 ng/L
Interval 41.52 to 150.14
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-4 : Day 8 Post-Vaccination 1
|
63.89 ng/L
Interval 41.87 to 106.36
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-4 : Day 29 Post-Vaccination 1
|
—
|
59.46 ng/L
Interval 42.24 to 132.19
|
59.83 ng/L
Interval 41.62 to 158.67
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-4 : Day 2 Post-Vaccination 2
|
—
|
66.66 ng/L
Interval 33.95 to 135.48
|
61.47 ng/L
Interval 38.94 to 136.29
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-4 : Day 4 Post-Vaccination 2
|
—
|
67.74 ng/L
Interval 35.01 to 121.38
|
59.86 ng/L
Interval 40.82 to 167.25
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-4 : Day 8 Post-Vaccination 2
|
—
|
54.44 ng/L
Interval 39.43 to 159.9
|
63.96 ng/L
Interval 37.41 to 122.34
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-5 : Day 1 Pre-Vaccination
|
3.22 ng/L
Interval 1.54 to 6.26
|
3.92 ng/L
Interval 2.46 to 5.98
|
2.82 ng/L
Interval 2.16 to 7.27
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-5 : Day 2 Post-Vaccination 1
|
3.04 ng/L
Interval 1.55 to 7.85
|
4.54 ng/L
Interval 2.46 to 5.53
|
2.84 ng/L
Interval 2.12 to 6.93
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-5 : Day 4 Post-Vaccination 1
|
2.96 ng/L
Interval 1.45 to 7.93
|
4.73 ng/L
Interval 2.9 to 6.04
|
3.03 ng/L
Interval 1.79 to 8.55
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-5 : Day 8 Post-Vaccination 1
|
2.50 ng/L
Interval 1.66 to 9.71
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-5 : Day 29 Post-Vaccination 1
|
—
|
4.56 ng/L
Interval 2.35 to 7.5
|
3.33 ng/L
Interval 2.08 to 6.96
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-5 : Day 2 Post-Vaccination 2
|
—
|
4.83 ng/L
Interval 2.75 to 9.01
|
3.03 ng/L
Interval 1.88 to 6.98
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-5 : Day 4 Post-Vaccination 2
|
—
|
4.15 ng/L
Interval 2.56 to 7.36
|
3.04 ng/L
Interval 2.17 to 7.92
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-5 : Day 8 Post-Vaccination 2
|
—
|
4.78 ng/L
Interval 2.63 to 7.19
|
3.25 ng/L
Interval 1.77 to 6.43
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-6 : Day 1 Pre-Vaccination
|
2.02 ng/L
Interval 1.19 to 4.09
|
1.26 ng/L
Interval 0.86 to 5.33
|
3.39 ng/L
Interval 2.15 to 5.62
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-6 : Day 2 Post-Vaccination 1
|
2.03 ng/L
Interval 1.3 to 5.0
|
2.54 ng/L
Interval 1.73 to 6.08
|
3.23 ng/L
Interval 2.17 to 6.54
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-6 : Day 8 Post-Vaccination 1
|
2.28 ng/L
Interval 0.75 to 4.52
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-6 : Day 29 Post-Vaccination 1
|
—
|
1.75 ng/L
Interval 0.98 to 3.6
|
3.52 ng/L
Interval 2.33 to 4.6
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-6 : Day 2 Post-Vaccination 2
|
—
|
2.95 ng/L
Interval 2.2 to 4.6
|
3.09 ng/L
Interval 2.22 to 4.95
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-6 : Day 4 Post-Vaccination 2
|
—
|
1.48 ng/L
Interval 0.99 to 3.31
|
3.06 ng/L
Interval 2.21 to 4.92
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-6 : Day 8 Post-Vaccination 2
|
—
|
1.07 ng/L
Interval 0.71 to 3.33
|
3.11 ng/L
Interval 1.8 to 4.28
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-7 : Day 2 Post-Vaccination 1
|
3.90 ng/L
Interval 2.72 to 9.67
|
4.05 ng/L
Interval 1.75 to 11.04
|
5.12 ng/L
Interval 4.0 to 10.56
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-7 : Day 4 Post-Vaccination 1
|
3.71 ng/L
Interval 2.35 to 6.81
|
4.93 ng/L
Interval 1.75 to 11.18
|
4.97 ng/L
Interval 3.37 to 12.3
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-7 : Day 8 Post-Vaccination 1
|
3.89 ng/L
Interval 3.0 to 14.78
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-7 : Day 29 Post-Vaccination 1
|
—
|
5.85 ng/L
Interval 2.19 to 10.39
|
4.99 ng/L
Interval 4.06 to 9.92
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-7 : Day 2 Post-Vaccination 2
|
—
|
6.20 ng/L
Interval 2.27 to 11.2
|
4.41 ng/L
Interval 3.44 to 9.5
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-7 : Day 4 Post-Vaccination 2
|
—
|
5.56 ng/L
Interval 1.76 to 9.02
|
4.83 ng/L
Interval 3.04 to 9.12
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-7 : Day 8 Post-Vaccination 2
|
—
|
5.46 ng/L
Interval 2.66 to 12.88
|
4.03 ng/L
Interval 3.13 to 9.96
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-8 : Day 1 Pre-Vaccination
|
4.37 ng/L
Interval 3.27 to 28.92
|
6.97 ng/L
Interval 3.31 to 9.79
|
5.53 ng/L
Interval 3.26 to 10.62
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-8 : Day 2 Post-Vaccination 1
|
5.04 ng/L
Interval 4.03 to 16.04
|
6.76 ng/L
Interval 3.32 to 9.22
|
5.04 ng/L
Interval 3.14 to 10.18
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-8 : Day 4 Post-Vaccination 1
|
4.86 ng/L
Interval 3.8 to 16.79
|
7.47 ng/L
Interval 3.11 to 10.11
|
5.33 ng/L
Interval 3.58 to 9.75
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-8 : Day 8 Post-Vaccination 1
|
4.35 ng/L
Interval 3.5 to 24.83
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-8 : Day 29 Post-Vaccination 1
|
—
|
7.42 ng/L
Interval 2.9 to 9.27
|
4.53 ng/L
Interval 3.29 to 9.51
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-8 : Day 2 Post-Vaccination 2
|
—
|
8.41 ng/L
Interval 2.73 to 12.62
|
4.84 ng/L
Interval 3.16 to 8.89
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-8 : Day 4 Post-Vaccination 2
|
—
|
7.03 ng/L
Interval 2.11 to 10.18
|
4.70 ng/L
Interval 2.93 to 8.43
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-8 : Day 8 Post-Vaccination 2
|
—
|
5.64 ng/L
Interval 2.98 to 11.7
|
4.44 ng/L
Interval 3.06 to 9.07
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-12p70 : Day 1 Pre-Vaccination
|
3.96 ng/L
Interval 1.67 to 7.55
|
2.53 ng/L
Interval 1.36 to 6.09
|
5.33 ng/L
Interval 1.82 to 9.53
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-12p70 : Day 2 Post-Vaccination 1
|
3.93 ng/L
Interval 2.04 to 7.59
|
2.50 ng/L
Interval 1.4 to 6.32
|
4.18 ng/L
Interval 1.48 to 11.06
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-12p70 : Day 4 Post-Vaccination 1
|
3.95 ng/L
Interval 1.88 to 7.66
|
2.68 ng/L
Interval 1.7 to 6.27
|
4.90 ng/L
Interval 2.05 to 9.85
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-12p70 : Day 8 Post-Vaccination 1
|
4.63 ng/L
Interval 1.81 to 8.22
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-12p70 : Day 29 Post-Vaccination 1
|
—
|
3.65 ng/L
Interval 1.46 to 6.8
|
5.63 ng/L
Interval 1.64 to 7.53
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-12p70 : Day 2 Post-Vaccination 2
|
—
|
3.83 ng/L
Interval 1.34 to 8.87
|
5.01 ng/L
Interval 1.84 to 7.65
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-12p70 : Day 4 Post-Vaccination 2
|
—
|
3.69 ng/L
Interval 1.74 to 5.58
|
4.44 ng/L
Interval 2.33 to 8.64
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-12p70 : Day 8 Post-Vaccination 2
|
—
|
2.18 ng/L
Interval 1.66 to 7.71
|
5.08 ng/L
Interval 1.67 to 8.29
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-17A: Day 1 Pre-Vaccination
|
19.44 ng/L
Interval 11.52 to 26.02
|
14.04 ng/L
Interval 9.6 to 33.02
|
24.34 ng/L
Interval 18.45 to 39.84
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-17A : Day 2 Post-Vaccination 1
|
18.06 ng/L
Interval 11.27 to 29.38
|
15.12 ng/L
Interval 8.0 to 36.45
|
20.96 ng/L
Interval 16.61 to 38.07
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-17A : Day 4 Post-Vaccination 1
|
20.03 ng/L
Interval 11.4 to 34.12
|
14.86 ng/L
Interval 9.26 to 35.99
|
22.84 ng/L
Interval 16.82 to 34.56
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-17A : Day 8 Post-Vaccination 1
|
22.21 ng/L
Interval 11.47 to 33.23
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-17A : Day 29 Post-Vaccination 1
|
—
|
17.44 ng/L
Interval 9.81 to 37.0
|
23.83 ng/L
Interval 20.33 to 30.67
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-17A : Day 2 Post-Vaccination 2
|
—
|
18.69 ng/L
Interval 8.98 to 35.8
|
23.50 ng/L
Interval 18.52 to 30.2
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-17A : Day 4 Post-Vaccination 2
|
—
|
16.66 ng/L
Interval 9.39 to 32.65
|
21.67 ng/L
Interval 18.7 to 34.83
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 2
IL-17A : Day 8 Post-Vaccination 2
|
—
|
13.24 ng/L
Interval 10.13 to 27.27
|
21.34 ng/L
Interval 16.22 to 30.88
|
SECONDARY outcome
Timeframe: Day 1 Pre-Vaccination 1; Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)Population: The intent-to-treat (ITT) population: Includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported. No cytokine or chemokine measurements were collected for the A/H3N2v arm after Day 8 Post-Vaccination 1 (Day 8), and for the A/H7N9 + AS03 and A/H7N9 arms at Day 8 Post-Vaccination 1 (Day 8).
Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 4 of the total 24 cytokines and chemokines were measured: Macrophage Inflammatory Protein-1 Alpha (MIP1a), Macrophage Inflammatory Protein-1 Beta (MIP1b), Macrophage Inflammatory Protein-3 Alpha (MIP3a), and Tumor Necrosis Factor Alpha (TNF-a). If no cytokine or chemokine measurements were collected, number of participants is reported as 0.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1a : Day 2 Post-Vaccination 2
|
—
|
29.90 ng/L
Interval 22.66 to 39.17
|
21.25 ng/L
Interval 18.28 to 43.92
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1a : Day 4 Post-Vaccination 2
|
—
|
24.08 ng/L
Interval 17.7 to 38.31
|
23.44 ng/L
Interval 17.45 to 44.09
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP3a : Day 1 Pre-Vaccination
|
16.77 ng/L
Interval 11.1 to 32.16
|
15.34 ng/L
Interval 9.87 to 29.55
|
16.60 ng/L
Interval 12.26 to 33.44
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP3a : Day 2 Post-Vaccination 2
|
—
|
16.24 ng/L
Interval 11.39 to 25.25
|
14.27 ng/L
Interval 11.3 to 31.88
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1a : Day 1 Pre-Vaccination
|
25.49 ng/L
Interval 15.16 to 42.51
|
24.86 ng/L
Interval 17.98 to 38.64
|
22.98 ng/L
Interval 18.0 to 41.08
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1a : Day 2 Post-Vaccination 1
|
24.56 ng/L
Interval 14.79 to 43.5
|
24.96 ng/L
Interval 17.78 to 40.41
|
23.13 ng/L
Interval 16.62 to 45.8
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1a : Day 4 Post-Vaccination 1
|
23.86 ng/L
Interval 15.07 to 50.72
|
24.44 ng/L
Interval 19.5 to 37.41
|
22.34 ng/L
Interval 18.16 to 46.99
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1a : Day 8 Post-Vaccination 1
|
27.64 ng/L
Interval 16.04 to 54.73
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1a : Day 29 Post-Vaccination 1
|
—
|
26.08 ng/L
Interval 18.52 to 36.89
|
23.09 ng/L
Interval 17.91 to 43.35
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1a : Day 8 Post-Vaccination 2
|
—
|
33.32 ng/L
Interval 15.4 to 41.68
|
22.54 ng/L
Interval 15.73 to 42.55
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1b : Day 1 Pre-Vaccination
|
18.63 ng/L
Interval 15.69 to 31.89
|
12.99 ng/L
Interval 10.99 to 27.31
|
20.33 ng/L
Interval 14.53 to 36.98
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1b : Day 2 Post-Vaccination 1
|
20.43 ng/L
Interval 17.9 to 31.63
|
16.90 ng/L
Interval 12.06 to 33.56
|
19.84 ng/L
Interval 13.91 to 34.72
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1b : Day 4 Post-Vaccination 1
|
20.47 ng/L
Interval 16.69 to 27.61
|
14.76 ng/L
Interval 10.77 to 33.98
|
19.16 ng/L
Interval 15.58 to 40.36
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1b : Day 8 Post-Vaccination 1
|
23.67 ng/L
Interval 16.79 to 37.81
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1b : Day 29 Post-Vaccination 1
|
—
|
16.05 ng/L
Interval 9.66 to 28.29
|
18.35 ng/L
Interval 12.76 to 35.12
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1b : Day 2 Post-Vaccination 2
|
—
|
29.05 ng/L
Interval 18.38 to 40.59
|
16.78 ng/L
Interval 13.36 to 32.55
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1b : Day 4 Post-Vaccination 2
|
—
|
14.42 ng/L
Interval 10.92 to 23.29
|
17.56 ng/L
Interval 14.29 to 36.42
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP1b : Day 8 Post-Vaccination 2
|
—
|
16.18 ng/L
Interval 10.86 to 28.51
|
16.18 ng/L
Interval 14.61 to 32.97
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP3a : Day 2 Post-Vaccination 1
|
19.59 ng/L
Interval 11.39 to 24.35
|
13.90 ng/L
Interval 8.92 to 25.28
|
15.44 ng/L
Interval 13.38 to 32.35
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP3a : Day 4 Post-Vaccination 1
|
18.58 ng/L
Interval 10.93 to 27.55
|
16.49 ng/L
Interval 8.94 to 24.6
|
15.74 ng/L
Interval 14.29 to 29.96
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP3a : Day 8 Post-Vaccination 1
|
18.62 ng/L
Interval 13.23 to 34.32
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP3a : Day 29 Post-Vaccination 1
|
—
|
15.72 ng/L
Interval 11.19 to 27.29
|
16.05 ng/L
Interval 12.7 to 34.47
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP3a : Day 4 Post-Vaccination 2
|
—
|
16.24 ng/L
Interval 10.71 to 22.28
|
15.31 ng/L
Interval 12.46 to 40.7
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
MIP3a : Day 8 Post-Vaccination 2
|
—
|
19.01 ng/L
Interval 10.22 to 28.61
|
14.53 ng/L
Interval 12.18 to 50.55
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
TNF-a : Day 1 Pre-Vaccination
|
4.32 ng/L
Interval 3.64 to 8.29
|
4.18 ng/L
Interval 2.66 to 7.11
|
5.36 ng/L
Interval 3.85 to 9.95
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
TNF-a : Day 2 Post-Vaccination 1
|
5.13 ng/L
Interval 3.75 to 8.3
|
4.26 ng/L
Interval 3.18 to 8.59
|
5.40 ng/L
Interval 3.32 to 10.16
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
TNF-a : Day 4 Post-Vaccination 1
|
5.16 ng/L
Interval 4.02 to 7.83
|
4.78 ng/L
Interval 3.21 to 9.07
|
5.24 ng/L
Interval 4.09 to 12.87
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
TNF-a : Day 8 Post-Vaccination 1
|
4.48 ng/L
Interval 3.52 to 9.02
|
—
|
—
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
TNF-a : Day 29 Post-Vaccination 1
|
—
|
4.88 ng/L
Interval 2.95 to 8.0
|
4.93 ng/L
Interval 3.2 to 10.11
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
TNF-a : Day 2 Post-Vaccination 2
|
—
|
8.13 ng/L
Interval 5.61 to 11.9
|
4.78 ng/L
Interval 3.19 to 9.54
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
TNF-a : Day 4 Post-Vaccination 2
|
—
|
5.28 ng/L
Interval 3.34 to 7.34
|
5.26 ng/L
Interval 3.03 to 11.05
|
|
Cytokine and Chemokine Concentration by Study Arm and Study Visit Day - Part 3
TNF-a : Day 8 Post-Vaccination 2
|
—
|
4.56 ng/L
Interval 3.85 to 7.69
|
4.54 ng/L
Interval 3.23 to 9.62
|
SECONDARY outcome
Timeframe: Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)Population: The intent-to-treat (ITT) population: Includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported. No cytokine or chemokine measurements were collected for the A/H3N2v arm after Day 8 Post-Vaccination 1 (Day 8), and for the A/H7N9 + AS03 and A/H7N9 arms at Day 8 Post-Vaccination 1 (Day 8).
Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 7 of the total 24 cytokines and chemokines were measured: Fractalkine, GM-CSF, IP-10, IFNa, IFNb, IFNy, and ITAC. If no cytokine or chemokine measurements were collected, number of participants is reported as 0.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
Fractalkine : Day 2 Post-Vaccination 1
|
0.944 fold change
Interval 0.85 to 1.17
|
1.015 fold change
Interval 0.83 to 1.08
|
1.003 fold change
Interval 0.87 to 1.07
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
GM-CSF : Day 4 Post-Vaccination 1
|
1.096 fold change
Interval 0.96 to 1.2
|
0.932 fold change
Interval 0.85 to 1.17
|
0.971 fold change
Interval 0.86 to 1.1
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
GM-CSF : Day 4 Post-Vaccination 2
|
—
|
0.832 fold change
Interval 0.77 to 1.04
|
1.004 fold change
Interval 0.9 to 1.17
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IP-10 : Day 4 Post-Vaccination 1
|
0.983 fold change
Interval 0.76 to 1.09
|
1.445 fold change
Interval 0.75 to 1.81
|
0.977 fold change
Interval 0.85 to 1.15
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IP-10 : Day 29 Post-Vaccination 1
|
—
|
0.869 fold change
Interval 0.72 to 1.14
|
0.868 fold change
Interval 0.78 to 0.93
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IP-10 : Day 2 Post-Vaccination 2
|
—
|
4.461 fold change
Interval 2.19 to 8.26
|
1.097 fold change
Interval 1.03 to 1.34
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
Fractalkine : Day 2 Post-Vaccination 2
|
—
|
1.010 fold change
Interval 0.86 to 1.3
|
1.053 fold change
Interval 0.88 to 1.1
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
Fractalkine : Day 4 Post-Vaccination 1
|
1.024 fold change
Interval 0.91 to 1.35
|
1.092 fold change
Interval 0.89 to 1.47
|
0.946 fold change
Interval 0.84 to 1.14
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
Fractalkine : Day 8 Post-Vaccination 1
|
0.983 fold change
Interval 0.92 to 1.16
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
Fractalkine : Day 29 Post-Vaccination 1
|
—
|
0.999 fold change
Interval 0.9 to 1.24
|
1.063 fold change
Interval 0.86 to 1.08
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
Fractalkine : Day 4 Post-Vaccination 2
|
—
|
1.022 fold change
Interval 0.8 to 1.13
|
1.010 fold change
Interval 0.84 to 1.29
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
Fractalkine : Day 8 Post-Vaccination 2
|
—
|
0.931 fold change
Interval 0.77 to 1.25
|
0.985 fold change
Interval 0.88 to 1.1
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
GM-CSF : Day 2 Post-Vaccination 1
|
1.117 fold change
Interval 1.0 to 1.22
|
1.020 fold change
Interval 0.89 to 1.07
|
0.971 fold change
Interval 0.92 to 1.09
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
GM-CSF : Day 8 Post-Vaccination 1
|
1.043 fold change
Interval 0.97 to 1.2
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
GM-CSF : Day 29 Post-Vaccination 1
|
—
|
1.053 fold change
Interval 0.86 to 1.28
|
1.018 fold change
Interval 0.96 to 1.07
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
GM-CSF : Day 2 Post-Vaccination 2
|
—
|
1.107 fold change
Interval 0.94 to 1.21
|
0.994 fold change
Interval 0.9 to 1.06
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
GM-CSF : Day 8 Post-Vaccination 2
|
—
|
1.053 fold change
Interval 0.77 to 1.21
|
0.969 fold change
Interval 0.9 to 1.01
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IP-10 : Day 2 Post-Vaccination 1
|
0.988 fold change
Interval 0.87 to 1.25
|
1.867 fold change
Interval 0.99 to 2.74
|
1.065 fold change
Interval 0.91 to 1.19
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IP-10 : Day 8 Post-Vaccination 1
|
0.889 fold change
Interval 0.65 to 0.96
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IP-10 : Day 4 Post-Vaccination 2
|
—
|
1.450 fold change
Interval 1.16 to 1.93
|
1.111 fold change
Interval 0.97 to 1.34
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IP-10 : Day 8 Post-Vaccination 2
|
—
|
1.002 fold change
Interval 0.85 to 1.06
|
1.022 fold change
Interval 0.91 to 1.25
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNa : Day 2 Post-Vaccination 1
|
0.830 fold change
Interval 0.62 to 1.09
|
0.959 fold change
Interval 0.79 to 1.13
|
1.207 fold change
Interval 0.6 to 2.04
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNa : Day 4 Post-Vaccination 1
|
0.807 fold change
Interval 0.38 to 1.25
|
1.023 fold change
Interval 0.84 to 1.27
|
1.121 fold change
Interval 0.47 to 1.27
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNa : Day 8 Post-Vaccination 1
|
0.877 fold change
Interval 0.55 to 1.3
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNa : Day 29 Post-Vaccination 1
|
—
|
0.969 fold change
Interval 0.64 to 1.26
|
0.924 fold change
Interval 0.7 to 0.98
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNa : Day 2 Post-Vaccination 2
|
—
|
1.091 fold change
Interval 0.87 to 1.73
|
0.964 fold change
Interval 0.7 to 1.18
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNa : Day 4 Post-Vaccination 2
|
—
|
1.079 fold change
Interval 0.78 to 1.48
|
1.252 fold change
Interval 0.5 to 1.67
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNa : Day 8 Post-Vaccination 2
|
—
|
1.164 fold change
Interval 0.93 to 1.52
|
0.906 fold change
Interval 0.47 to 1.3
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNb : Day 2 Post-Vaccination 1
|
0.907 fold change
Interval 0.7 to 1.17
|
0.929 fold change
Interval 0.75 to 1.36
|
0.839 fold change
Interval 0.76 to 1.11
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNb : Day 4 Post-Vaccination 1
|
0.941 fold change
Interval 0.76 to 1.15
|
1.134 fold change
Interval 0.85 to 1.45
|
1.092 fold change
Interval 0.76 to 1.27
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNb : Day 8 Post-Vaccination 1
|
1.000 fold change
Interval 0.83 to 1.22
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNb : Day 29 Post-Vaccination 1
|
—
|
0.858 fold change
Interval 0.67 to 1.06
|
0.968 fold change
Interval 0.88 to 1.26
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNb : Day 2 Post-Vaccination 2
|
—
|
1.172 fold change
Interval 1.05 to 1.74
|
0.989 fold change
Interval 0.81 to 1.2
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNb : Day 4 Post-Vaccination 2
|
—
|
1.051 fold change
Interval 1.0 to 1.2
|
1.033 fold change
Interval 0.82 to 1.17
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNb : Day 8 Post-Vaccination 2
|
—
|
1.249 fold change
Interval 1.0 to 1.53
|
1.074 fold change
Interval 0.74 to 1.28
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNy : Day 2 Post-Vaccination 1
|
0.993 fold change
Interval 0.94 to 1.16
|
1.118 fold change
Interval 1.02 to 1.57
|
0.987 fold change
Interval 0.91 to 1.03
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNy : Day 4 Post-Vaccination 1
|
1.049 fold change
Interval 0.94 to 1.14
|
1.018 fold change
Interval 0.87 to 1.11
|
0.991 fold change
Interval 0.93 to 1.02
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNy : Day 8 Post-Vaccination 1
|
1.018 fold change
Interval 0.94 to 1.09
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNy : Day 29 Post-Vaccination 1
|
—
|
1.085 fold change
Interval 0.93 to 1.19
|
0.958 fold change
Interval 0.84 to 1.18
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNy : Day 2 Post-Vaccination 2
|
—
|
1.819 fold change
Interval 1.07 to 2.5
|
0.968 fold change
Interval 0.93 to 1.03
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNy : Day 4 Post-Vaccination 2
|
—
|
0.854 fold change
Interval 0.77 to 0.96
|
0.927 fold change
Interval 0.87 to 1.11
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
IFNy : Day 8 Post-Vaccination 2
|
—
|
0.973 fold change
Interval 0.8 to 1.07
|
0.927 fold change
Interval 0.85 to 1.01
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
ITAC : Day 2 Post-Vaccination 1
|
0.975 fold change
Interval 0.87 to 1.22
|
1.149 fold change
Interval 0.98 to 1.29
|
0.926 fold change
Interval 0.8 to 1.27
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
ITAC : Day 4 Post-Vaccination 1
|
1.020 fold change
Interval 0.86 to 1.36
|
1.160 fold change
Interval 0.99 to 1.26
|
0.953 fold change
Interval 0.75 to 1.17
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
ITAC : Day 8 Post-Vaccination 1
|
0.874 fold change
Interval 0.61 to 1.46
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
ITAC : Day 29 Post-Vaccination 1
|
—
|
0.895 fold change
Interval 0.81 to 1.07
|
0.913 fold change
Interval 0.76 to 0.98
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
ITAC : Day 2 Post-Vaccination 2
|
—
|
2.277 fold change
Interval 1.35 to 3.66
|
0.916 fold change
Interval 0.84 to 0.99
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
ITAC : Day 4 Post-Vaccination 2
|
—
|
1.098 fold change
Interval 0.9 to 1.26
|
0.852 fold change
Interval 0.66 to 1.21
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 1
ITAC : Day 8 Post-Vaccination 2
|
—
|
1.325 fold change
Interval 0.8 to 2.19
|
1.041 fold change
Interval 0.91 to 1.21
|
SECONDARY outcome
Timeframe: Days 2, 4, 8, and 29 Post-Vaccination 1 (Day 2, 4, 8, and 29, respectively); Days 2, 4, and 8 Post-Vaccination 2 (Day 30, 32, and 36, respectively)Population: The intent-to-treat (ITT) population: Includes all participants who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported. No cytokine or chemokine measurements were collected for the A/H3N2v arm after Day 8 Post-Vaccination 1 (Day 8), and for the A/H7N9 + AS03 and A/H7N9 arms at Day 8 Post-Vaccination 1 (Day 8).
Venous blood samples for plasma were used for this assay. A Luminex assay was used to measure concentrations in ng/L. Concentrations for 17 of the total 24 cytokines and chemokines were measured: IL-1b, IL-10, IL-13, IL-2, IL-21, IL-23, IL-4, IL-5, IL-6, IL-7, IL-8, IL-12p70, IL-17A, MIP1a, MIP1b, MIP3a, and TNF-a. If no cytokine or chemokine measurements were collected, number of participants is reported as 0.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-12p70 : Day 2 Post-Vaccination 2
|
—
|
1.026 fold change
Interval 0.86 to 1.24
|
1.002 fold change
Interval 0.81 to 1.15
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-12p70 : Day 4 Post-Vaccination 2
|
—
|
0.933 fold change
Interval 0.89 to 1.03
|
1.041 fold change
Interval 0.8 to 1.4
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-12p70 : Day 8 Post-Vaccination 2
|
—
|
0.901 fold change
Interval 0.82 to 1.22
|
0.936 fold change
Interval 0.75 to 1.15
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-17A : Day 2 Post-Vaccination 1
|
1.011 fold change
Interval 0.95 to 1.16
|
1.074 fold change
Interval 0.92 to 1.12
|
0.932 fold change
Interval 0.85 to 1.04
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-1b : Day 2 Post-Vaccination 2
|
—
|
0.942 fold change
Interval 0.81 to 1.34
|
0.940 fold change
Interval 0.89 to 1.19
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-1b : Day 4 Post-Vaccination 2
|
—
|
0.890 fold change
Interval 0.78 to 1.02
|
1.044 fold change
Interval 0.86 to 1.22
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-13 : Day 29 Post-Vaccination 1
|
—
|
1.074 fold change
Interval 0.84 to 1.42
|
0.990 fold change
Interval 0.89 to 1.19
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-2 : Day 2 Post-Vaccination 1
|
1.055 fold change
Interval 0.96 to 1.28
|
0.994 fold change
Interval 0.96 to 1.03
|
0.964 fold change
Interval 0.86 to 1.07
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-2 : Day 29 Post-Vaccination 1
|
—
|
1.119 fold change
Interval 0.86 to 1.85
|
0.997 fold change
Interval 0.71 to 1.14
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-21 : Day 4 Post-Vaccination 1
|
1.402 fold change
Interval 0.92 to 1.55
|
0.959 fold change
Interval 0.79 to 1.26
|
0.902 fold change
Interval 0.84 to 1.07
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-23 : Day 2 Post-Vaccination 1
|
0.907 fold change
Interval 0.82 to 1.06
|
0.998 fold change
Interval 0.89 to 1.12
|
0.929 fold change
Interval 0.83 to 1.3
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-12p70 : Day 2 Post-Vaccination 1
|
1.048 fold change
Interval 0.93 to 1.2
|
1.029 fold change
Interval 0.84 to 1.15
|
0.869 fold change
Interval 0.73 to 1.1
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-12p70 : Day 4 Post-Vaccination 1
|
1.057 fold change
Interval 0.92 to 1.14
|
1.029 fold change
Interval 0.94 to 1.26
|
0.916 fold change
Interval 0.81 to 1.03
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-12p70 : Day 8 Post-Vaccination 1
|
1.012 fold change
Interval 0.78 to 1.1
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-12p70 : Day 29 Post-Vaccination 1
|
—
|
1.052 fold change
Interval 0.95 to 1.6
|
1.059 fold change
Interval 0.65 to 1.14
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-1b : Day 2 Post-Vaccination 1
|
0.981 fold change
Interval 0.84 to 1.15
|
0.933 fold change
Interval 0.86 to 1.07
|
0.950 fold change
Interval 0.88 to 1.16
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-1b : Day 4 Post-Vaccination 1
|
1.050 fold change
Interval 0.9 to 1.21
|
1.004 fold change
Interval 0.83 to 1.28
|
0.996 fold change
Interval 0.8 to 1.12
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-1b : Day 8 Post-Vaccination 1
|
0.989 fold change
Interval 0.85 to 1.08
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-1b : Day 29 Post-Vaccination 1
|
—
|
1.022 fold change
Interval 0.98 to 1.28
|
0.938 fold change
Interval 0.8 to 1.12
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-1b : Day 8 Post-Vaccination 2
|
—
|
1.106 fold change
Interval 0.78 to 1.28
|
0.957 fold change
Interval 0.81 to 1.07
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-10 : Day 2 Post-Vaccination 1
|
1.106 fold change
Interval 0.9 to 1.21
|
1.028 fold change
Interval 0.87 to 1.19
|
0.975 fold change
Interval 0.84 to 1.12
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-10 : Day 4 Post-Vaccination 1
|
1.043 fold change
Interval 0.92 to 1.3
|
1.118 fold change
Interval 0.95 to 1.25
|
1.003 fold change
Interval 0.81 to 1.16
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-10 : Day 8 Post-Vaccination 1
|
0.979 fold change
Interval 0.81 to 1.12
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-10 : Day 29 Post-Vaccination 1
|
—
|
1.076 fold change
Interval 0.96 to 1.5
|
1.032 fold change
Interval 0.79 to 1.18
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-10 : Day 2 Post-Vaccination 2
|
—
|
1.099 fold change
Interval 0.91 to 1.29
|
0.919 fold change
Interval 0.85 to 0.98
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-10 : Day 4 Post-Vaccination 2
|
—
|
0.950 fold change
Interval 0.84 to 1.13
|
0.962 fold change
Interval 0.77 to 1.15
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-10 : Day 8 Post-Vaccination 2
|
—
|
0.979 fold change
Interval 0.83 to 1.21
|
0.875 fold change
Interval 0.76 to 1.01
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-13 : Day 2 Post-Vaccination 1
|
1.021 fold change
Interval 0.94 to 1.09
|
1.024 fold change
Interval 0.91 to 1.1
|
0.982 fold change
Interval 0.83 to 1.17
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-13 : Day 4 Post-Vaccination 1
|
1.059 fold change
Interval 0.97 to 1.18
|
0.988 fold change
Interval 0.95 to 1.07
|
0.994 fold change
Interval 0.87 to 1.05
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-13 : Day 8 Post-Vaccination 1
|
1.065 fold change
Interval 0.88 to 1.11
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-13 : Day 2 Post-Vaccination 2
|
—
|
0.973 fold change
Interval 0.9 to 1.05
|
0.988 fold change
Interval 0.91 to 1.03
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-13 : Day 4 Post-Vaccination 2
|
—
|
0.979 fold change
Interval 0.82 to 1.23
|
0.976 fold change
Interval 0.9 to 1.01
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-13 : Day 8 Post-Vaccination 2
|
—
|
1.013 fold change
Interval 0.77 to 1.13
|
0.975 fold change
Interval 0.89 to 1.04
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-2 : Day 4 Post-Vaccination 1
|
1.020 fold change
Interval 0.89 to 1.21
|
1.024 fold change
Interval 0.91 to 1.24
|
0.908 fold change
Interval 0.85 to 1.11
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-2 : Day 8 Post-Vaccination 1
|
1.080 fold change
Interval 0.76 to 1.09
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-2 : Day 2 Post-Vaccination 2
|
—
|
1.059 fold change
Interval 0.68 to 1.17
|
0.901 fold change
Interval 0.83 to 1.03
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-2 : Day 4 Post-Vaccination 2
|
—
|
0.907 fold change
Interval 0.69 to 1.09
|
1.023 fold change
Interval 0.78 to 1.16
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-2 : Day 8 Post-Vaccination 2
|
—
|
1.031 fold change
Interval 0.74 to 1.28
|
0.927 fold change
Interval 0.84 to 0.97
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-21 : Day 2 Post-Vaccination 1
|
1.152 fold change
Interval 0.93 to 1.42
|
0.992 fold change
Interval 0.85 to 1.15
|
0.932 fold change
Interval 0.85 to 1.21
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-21 : Day 8 Post-Vaccination 1
|
1.149 fold change
Interval 0.75 to 1.33
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-21 : Day 29 Post-Vaccination 1
|
—
|
1.213 fold change
Interval 1.15 to 1.44
|
0.916 fold change
Interval 0.86 to 1.08
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-21 : Day 2 Post-Vaccination 2
|
—
|
1.099 fold change
Interval 0.95 to 1.28
|
1.040 fold change
Interval 0.85 to 1.06
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-21 : Day 4 Post-Vaccination 2
|
—
|
0.932 fold change
Interval 0.77 to 1.03
|
0.924 fold change
Interval 0.79 to 1.21
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-21 : Day 8 Post-Vaccination 2
|
—
|
0.861 fold change
Interval 0.62 to 1.18
|
0.880 fold change
Interval 0.72 to 1.18
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-23 : Day 4 Post-Vaccination 1
|
1.014 fold change
Interval 0.78 to 1.47
|
1.006 fold change
Interval 0.81 to 1.27
|
0.949 fold change
Interval 0.82 to 1.23
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-23 : Day 8 Post-Vaccination 1
|
0.930 fold change
Interval 0.69 to 1.06
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-23 : Day 29 Post-Vaccination 1
|
—
|
1.041 fold change
Interval 0.91 to 1.28
|
0.993 fold change
Interval 0.72 to 1.18
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-23 : Day 2 Post-Vaccination 2
|
—
|
1.046 fold change
Interval 0.89 to 1.24
|
0.956 fold change
Interval 0.88 to 1.19
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-23 : Day 4 Post-Vaccination 2
|
—
|
1.032 fold change
Interval 0.8 to 1.21
|
0.982 fold change
Interval 0.7 to 1.28
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-23 : Day 8 Post-Vaccination 2
|
—
|
0.954 fold change
Interval 0.77 to 1.46
|
0.979 fold change
Interval 0.79 to 1.07
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-4 : Day 2 Post-Vaccination 1
|
0.992 fold change
Interval 0.85 to 1.18
|
1.038 fold change
Interval 0.93 to 1.13
|
1.034 fold change
Interval 0.91 to 1.24
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-4 : Day 4 Post-Vaccination 1
|
1.013 fold change
Interval 0.83 to 1.27
|
1.028 fold change
Interval 0.84 to 1.17
|
0.921 fold change
Interval 0.84 to 1.13
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-4 : Day 8 Post-Vaccination 1
|
0.969 fold change
Interval 0.87 to 1.16
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-4 : Day 29 Post-Vaccination 1
|
—
|
1.038 fold change
Interval 0.91 to 1.19
|
1.014 fold change
Interval 0.87 to 1.17
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-4 : Day 2 Post-Vaccination 2
|
—
|
1.014 fold change
Interval 0.83 to 1.15
|
0.969 fold change
Interval 0.86 to 1.06
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-4 : Day 4 Post-Vaccination 2
|
—
|
0.983 fold change
Interval 0.83 to 1.13
|
0.935 fold change
Interval 0.74 to 1.13
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-4 : Day 8 Post-Vaccination 2
|
—
|
1.083 fold change
Interval 0.89 to 1.16
|
0.910 fold change
Interval 0.73 to 1.08
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-5 : Day 2 Post-Vaccination 1
|
1.062 fold change
Interval 0.85 to 1.22
|
1.029 fold change
Interval 0.92 to 1.17
|
0.978 fold change
Interval 0.84 to 1.1
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-5 : Day 4 Post-Vaccination 1
|
0.986 fold change
Interval 0.83 to 1.24
|
1.074 fold change
Interval 0.94 to 1.42
|
1.037 fold change
Interval 0.77 to 1.27
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-5 : Day 8 Post-Vaccination 1
|
1.009 fold change
Interval 0.8 to 1.11
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-5 : Day 29 Post-Vaccination 1
|
—
|
1.010 fold change
Interval 0.85 to 1.33
|
1.040 fold change
Interval 0.9 to 1.15
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-5 : Day 2 Post-Vaccination 2
|
—
|
1.122 fold change
Interval 0.98 to 1.38
|
0.980 fold change
Interval 0.81 to 1.05
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-5 : Day 4 Post-Vaccination 2
|
—
|
1.022 fold change
Interval 0.94 to 1.19
|
0.960 fold change
Interval 0.87 to 1.19
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-5 : Day 8 Post-Vaccination 2
|
—
|
1.123 fold change
Interval 0.75 to 1.35
|
0.965 fold change
Interval 0.77 to 1.03
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-6 : Day 2 Post-Vaccination 1
|
1.123 fold change
Interval 1.0 to 1.59
|
1.601 fold change
Interval 1.25 to 2.14
|
0.952 fold change
Interval 0.92 to 1.14
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-6 : Day 4 Post-Vaccination 1
|
1.075 fold change
Interval 0.9 to 1.55
|
0.990 fold change
Interval 0.7 to 1.15
|
0.969 fold change
Interval 0.89 to 1.18
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-6 : Day 8 Post-Vaccination 1
|
0.970 fold change
Interval 0.63 to 1.13
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-6 : Day 29 Post-Vaccination 1
|
—
|
0.921 fold change
Interval 0.7 to 1.5
|
0.996 fold change
Interval 0.79 to 1.1
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-6 : Day 2 Post-Vaccination 2
|
—
|
1.827 fold change
Interval 1.19 to 2.68
|
0.942 fold change
Interval 0.87 to 1.11
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-6 : Day 4 Post-Vaccination 2
|
—
|
0.907 fold change
Interval 0.8 to 1.15
|
1.054 fold change
Interval 0.75 to 1.21
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-6 : Day 8 Post-Vaccination 2
|
—
|
0.921 fold change
Interval 0.61 to 1.14
|
0.961 fold change
Interval 0.79 to 1.11
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-7 : Day 2 Post-Vaccination 1
|
1.080 fold change
Interval 0.84 to 1.22
|
1.010 fold change
Interval 0.9 to 1.22
|
0.982 fold change
Interval 0.84 to 1.25
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-7 : Day 4 Post-Vaccination 1
|
0.952 fold change
Interval 0.68 to 1.31
|
1.009 fold change
Interval 0.88 to 1.27
|
0.934 fold change
Interval 0.8 to 1.35
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-7 : Day 8 Post-Vaccination 1
|
1.000 fold change
Interval 0.79 to 1.17
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-7 : Day 29 Post-Vaccination 1
|
—
|
0.969 fold change
Interval 0.88 to 1.01
|
0.976 fold change
Interval 0.76 to 1.15
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-7 : Day 2 Post-Vaccination 2
|
—
|
0.953 fold change
Interval 0.84 to 1.28
|
0.979 fold change
Interval 0.86 to 1.07
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-7 : Day 4 Post-Vaccination 2
|
—
|
0.816 fold change
Interval 0.71 to 1.13
|
0.966 fold change
Interval 0.88 to 1.25
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-7 : Day 8 Post-Vaccination 2
|
—
|
1.262 fold change
Interval 1.02 to 1.46
|
1.022 fold change
Interval 0.78 to 1.11
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-8 : Day 2 Post-Vaccination 1
|
1.111 fold change
Interval 0.93 to 1.34
|
1.045 fold change
Interval 0.86 to 1.11
|
0.960 fold change
Interval 0.89 to 1.07
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-8 : Day 4 Post-Vaccination 1
|
1.073 fold change
Interval 0.87 to 1.31
|
0.943 fold change
Interval 0.88 to 1.06
|
0.944 fold change
Interval 0.81 to 1.07
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-8 : Day 8 Post-Vaccination 1
|
1.039 fold change
Interval 0.9 to 1.07
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-8 : Day 29 Post-Vaccination 1
|
—
|
0.970 fold change
Interval 0.79 to 1.31
|
0.914 fold change
Interval 0.78 to 1.01
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-8 : Day 2 Post-Vaccination 2
|
—
|
1.134 fold change
Interval 0.94 to 1.28
|
0.988 fold change
Interval 0.94 to 1.07
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-8 : Day 4 Post-Vaccination 2
|
—
|
0.834 fold change
Interval 0.73 to 1.04
|
1.065 fold change
Interval 0.89 to 1.18
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-8 : Day 8 Post-Vaccination 2
|
—
|
1.299 fold change
Interval 0.75 to 1.52
|
0.966 fold change
Interval 0.9 to 1.04
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-17A : Day 4 Post-Vaccination 1
|
1.053 fold change
Interval 0.86 to 1.2
|
1.019 fold change
Interval 0.92 to 1.18
|
0.911 fold change
Interval 0.88 to 1.01
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-17A : Day 8 Post-Vaccination 1
|
0.965 fold change
Interval 0.94 to 1.12
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-17A : Day 29 Post-Vaccination 1
|
—
|
1.153 fold change
Interval 1.01 to 1.32
|
0.908 fold change
Interval 0.79 to 1.17
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-17A : Day 2 Post-Vaccination 2
|
—
|
0.970 fold change
Interval 0.92 to 1.06
|
0.988 fold change
Interval 0.91 to 1.02
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-17A : Day 4 Post-Vaccination 2
|
—
|
0.913 fold change
Interval 0.82 to 0.98
|
0.999 fold change
Interval 0.84 to 1.117
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
IL-17A : Day 8 Post-Vaccination 2
|
—
|
0.891 fold change
Interval 0.61 to 1.17
|
0.956 fold change
Interval 0.75 to 1.03
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1a : Day 2 Post-Vaccination 1
|
1.024 fold change
Interval 0.95 to 1.11
|
1.035 fold change
Interval 0.99 to 1.04
|
0.963 fold change
Interval 0.93 to 1.12
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1a : Day 4 Post-Vaccination 1
|
1.089 fold change
Interval 0.93 to 1.17
|
1.037 fold change
Interval 0.94 to 1.11
|
0.997 fold change
Interval 0.92 to 1.08
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1a : Day 8 Post-Vaccination 1
|
0.966 fold change
Interval 0.91 to 1.06
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1a : Day 29 Post-Vaccination 1
|
—
|
1.049 fold change
Interval 0.87 to 1.17
|
1.018 fold change
Interval 0.85 to 1.08
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1a : Day 2 Post-Vaccination 2
|
—
|
1.018 fold change
Interval 0.96 to 1.14
|
1.008 fold change
Interval 0.91 to 1.05
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1a : Day 4 Post-Vaccination 2
|
—
|
0.961 fold change
Interval 0.85 to 1.06
|
0.978 fold change
Interval 0.92 to 1.11
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1a : Day 8 Post-Vaccination 2
|
—
|
1.097 fold change
Interval 0.96 to 1.23
|
0.970 fold change
Interval 0.89 to 1.04
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1b : Day 2 Post-Vaccination 1
|
1.192 fold change
Interval 0.88 to 1.27
|
1.187 fold change
Interval 0.94 to 1.33
|
0.955 fold change
Interval 0.91 to 1.09
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1b : Day 4 Post-Vaccination 1
|
1.027 fold change
Interval 0.81 to 1.18
|
1.030 fold change
Interval 0.99 to 1.2
|
1.023 fold change
Interval 0.86 to 1.21
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1b : Day 8 Post-Vaccination 1
|
1.038 fold change
Interval 1.01 to 1.07
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1b : Day 29 Post-Vaccination 1
|
—
|
0.958 fold change
Interval 0.81 to 1.19
|
0.942 fold change
Interval 0.84 to 1.05
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1b : Day 2 Post-Vaccination 2
|
—
|
1.576 fold change
Interval 1.24 to 2.21
|
0.950 fold change
Interval 0.9 to 1.13
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1b : Day 4 Post-Vaccination 2
|
—
|
0.985 fold change
Interval 0.84 to 1.07
|
1.111 fold change
Interval 0.85 to 1.22
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP1b : Day 8 Post-Vaccination 2
|
—
|
1.194 fold change
Interval 0.86 to 1.32
|
0.960 fold change
Interval 0.87 to 1.1
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP3a : Day 2 Post-Vaccination 1
|
1.085 fold change
Interval 0.82 to 1.25
|
0.979 fold change
Interval 0.82 to 1.01
|
0.968 fold change
Interval 0.8 to 1.09
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP3a : Day 4 Post-Vaccination 1
|
1.056 fold change
Interval 0.91 to 1.15
|
0.990 fold change
Interval 0.82 to 1.13
|
0.976 fold change
Interval 0.85 to 1.06
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP3a : Day 8 Post-Vaccination 1
|
0.976 fold change
Interval 0.93 to 1.19
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP3a : Day 29 Post-Vaccination 1
|
—
|
0.945 fold change
Interval 0.9 to 1.08
|
0.891 fold change
Interval 0.72 to 1.11
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP3a : Day 2 Post-Vaccination 2
|
—
|
1.033 fold change
Interval 0.9 to 1.16
|
0.943 fold change
Interval 0.85 to 1.23
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP3a : Day 4 Post-Vaccination 2
|
—
|
1.036 fold change
Interval 0.91 to 1.2
|
1.021 fold change
Interval 0.93 to 1.25
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
MIP3a : Day 8 Post-Vaccination 2
|
—
|
1.055 fold change
Interval 0.91 to 1.57
|
1.076 fold change
Interval 0.9 to 1.67
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
TNF-a : Day 2 Post-Vaccination 1
|
1.022 fold change
Interval 1.0 to 1.36
|
1.132 fold change
Interval 0.94 to 1.2
|
0.929 fold change
Interval 0.85 to 1.08
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
TNF-a : Day 4 Post-Vaccination 1
|
0.965 fold change
Interval 0.92 to 1.33
|
1.148 fold change
Interval 0.99 to 1.29
|
1.070 fold change
Interval 0.86 to 1.18
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
TNF-a : Day 8 Post-Vaccination 1
|
0.998 fold change
Interval 0.88 to 1.07
|
—
|
—
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
TNF-a : Day 29 Post-Vaccination 1
|
—
|
0.977 fold change
Interval 0.82 to 1.24
|
0.869 fold change
Interval 0.79 to 1.06
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
TNF-a : Day 2 Post-Vaccination 2
|
—
|
1.634 fold change
Interval 1.38 to 1.95
|
1.009 fold change
Interval 0.88 to 1.18
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
TNF-a : Day 4 Post-Vaccination 2
|
—
|
1.112 fold change
Interval 0.89 to 1.22
|
1.047 fold change
Interval 0.84 to 1.32
|
|
Fold Change in Cytokine and Chemokine Concentrations From Pre-vaccination - Part 2
TNF-a : Day 8 Post-Vaccination 2
|
—
|
1.199 fold change
Interval 0.77 to 1.46
|
0.984 fold change
Interval 0.89 to 1.16
|
SECONDARY outcome
Timeframe: Day 29 Post-Vaccination 2 (Day 57)Population: The intent-to-treat (ITT) population, A/H7N9 + AS03 and A/H7N9 arms: Includes all participants in the A/H7N9 + AS03 and A/H7N9 arms who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported.
Seroconversion is defined as either a pre-vaccination Neut titer \<1:10 and a post-vaccination Neut titer =\>1:40 or a pre-vaccination Neut titer =\>1:10 and a minimum four-fold rise in post-vaccination Neut titer. Venous blood samples for serum were used for this assay. Neut based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion Based on Neut Titer (A/H7N9 Vaccine, With and Without Adjuvant)
|
100 percentage of participants
Interval 69.2 to 100.0
|
0 percentage of participants
Interval 0.0 to 30.8
|
—
|
SECONDARY outcome
Timeframe: Day 29 Post-Vaccination 1 (Day 29)Population: The intent-to-treat (ITT) population, A/H3N2v arm: Includes all participants in the A/H3N2v arm who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported.
Seroconversion is defined as either a pre-vaccination Neut titer \<1:10 and a post-vaccination Neut titer =\>1:40 or a pre-vaccination Neut titer =\>1:10 and a minimum four-fold rise in post-vaccination Neut titer. Venous blood samples for serum were used for this assay. Neut based on the H3N2 strain A/Minnesota/11/2010 were assessed.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion Based on Neut Titer (A/H3N2v Vaccine)
|
40 percentage of participants
Interval 12.2 to 73.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Vaccination 1, Day 29 Post-Vaccination 1 (Day 29), and Day 29 Post-Vaccination 2 (Day 57)Population: The intent-to-treat (ITT) population, A/H7N9 + AS03 and A/H7N9 arms: Includes all participants in the A/H7N9 + AS03 and A/H7N9 arms who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported.
Venous blood samples for serum were used for this assay. HAI based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Geometric Mean Titers of Serum HAI Antibody (A/H7N9 Vaccine, With and Without Adjuvant)
Day 1 (Pre-Vaccination 1)
|
5.2 titer
Interval 4.8 to 5.6
|
5.0 titer
Value is N/A because all subjects had the same value, so no 95% CI is presented.
|
—
|
|
Geometric Mean Titers of Serum HAI Antibody (A/H7N9 Vaccine, With and Without Adjuvant)
Day 29 (Post-Vaccination 1)
|
7.3 titer
Interval 4.2 to 12.9
|
5.2 titer
Interval 4.8 to 5.6
|
—
|
|
Geometric Mean Titers of Serum HAI Antibody (A/H7N9 Vaccine, With and Without Adjuvant)
Day 29 (Post-Vaccination 2)
|
85.7 titer
Interval 26.7 to 275.6
|
5.0 titer
Value is N/A because all subjects had the same value, so no 95% CI is presented.
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Vaccination 1 (Day 1), Day 29 Post-Vaccination 1 (Day 29)Population: The intent-to-treat (ITT) population, A/H3N2v arm: Includes all participants in the A/H3N2v arm who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported.
Venous blood samples for serum were used for this assay. HAI based on the H3N2 strain A/Minnesota/11/2010 were assessed.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Geometric Mean Titers of Serum HAI Antibody (A/H3N2v Vaccine)
Day 1 Pre-Vaccination 1
|
37.3 titer
Interval 16.4 to 85.1
|
—
|
—
|
|
Geometric Mean Titers of Serum HAI Antibody (A/H3N2v Vaccine)
Day 29 Post-Vaccination 1
|
144.2 titer
Interval 44.8 to 464.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Vaccination 1 (Day 1), Day 29 Post-Vaccination 1 (Day 29), and Day 29 Post-Vaccination 2 (Day 57)Population: The intent-to-treat (ITT) population, A/H7N9 + AS03 and A/H7N9 arms: Includes all participants in the A/H7N9 + AS03 and A/H7N9 arms who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported.
Venous blood samples for serum were used for this assay. Neut based on the H7N9 strain A/Shanghai/02/2013xPR8 were assessed.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Geometric Mean Titers of Serum Neut Antibody (A/H7N9 Vaccine, With and Without Adjuvant)
Day 1 (Pre-Vaccination 1)
|
5.0 titer
Value is N/A because all subjects had the same value, so no 95% CI is presented.
|
5.0 titer
Value is N/A because all subjects had the same value, so no 95% CI is presented.
|
—
|
|
Geometric Mean Titers of Serum Neut Antibody (A/H7N9 Vaccine, With and Without Adjuvant)
Day 29 (Post-Vaccination 1)
|
17.4 titer
Interval 11.6 to 26.2
|
5.4 titer
Interval 4.6 to 6.3
|
—
|
|
Geometric Mean Titers of Serum Neut Antibody (A/H7N9 Vaccine, With and Without Adjuvant)
Day 29 (Post-Vaccination 2)
|
190.3 titer
Interval 112.5 to 321.9
|
5.9 titer
Interval 4.5 to 7.8
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-Vaccination 1 (Day 1), Day 29 Post-Vaccination 1 (Day 29)Population: The intent-to-treat (ITT) population, A/H3N2v arm: Includes all participants in the A/H3N2v arm who received at least one dose of study vaccine and contributed both pre- and at least one post-study vaccination blood samples for serological assessment (HAI or Neut antibody assays) for which valid results were reported.
Venous blood samples for serum were used for this assay. Neut based on the H3N2 strain A/Minnesota/11/2010 were assessed.
Outcome measures
| Measure |
A/H7N9 + AS03
n=10 Participants
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine with AS03 adjuvant at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
A/H7N9
Two doses of 3.75 ug of monovalent inactivated influenza A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Geometric Mean Titers of Serum Neut Antibody (A/H3N2v Vaccine)
Day 1 Pre-Vaccination 1
|
171.5 titer
Interval 86.1 to 341.7
|
—
|
—
|
|
Geometric Mean Titers of Serum Neut Antibody (A/H3N2v Vaccine)
Day 29 Post-Vaccination 1
|
485.0 titer
Interval 229.9 to 1023.2
|
—
|
—
|
Adverse Events
A/H3N2v
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
A/H7N9 + AS03
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
A/H7N9 + PBS
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A/H3N2v
n=10 participants at risk
One dose of 15 ug of A/H3N2v virus vaccine at Day 1
|
A/H7N9 + AS03
n=10 participants at risk
Two doses of 3.75 µg of AH7N9 virus vaccine + AS03 adjuvant at Day 1 and Day 29
|
A/H7N9 + PBS
n=10 participants at risk
Two doses of 3.75 µg of A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
Other adverse events
| Measure |
A/H3N2v
n=10 participants at risk
One dose of 15 ug of A/H3N2v virus vaccine at Day 1
|
A/H7N9 + AS03
n=10 participants at risk
Two doses of 3.75 µg of AH7N9 virus vaccine + AS03 adjuvant at Day 1 and Day 29
|
A/H7N9 + PBS
n=10 participants at risk
Two doses of 3.75 µg of A/H7N9 virus vaccine at Day 1 and Day 29
|
|---|---|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Eye disorders
Conjunctival Hyperaemia
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 2 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
70.0%
7/10 • Number of events 10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
30.0%
3/10 • Number of events 3 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
General disorders
Feeling Hot
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
40.0%
4/10 • Number of events 4 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
30.0%
3/10 • Number of events 3 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
General disorders
Injection Site Erythema
|
20.0%
2/10 • Number of events 2 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
70.0%
7/10 • Number of events 10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
General disorders
Injection Site Haemorrhage
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
30.0%
3/10 • Number of events 3 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
General disorders
Injection Site Induration
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
30.0%
3/10 • Number of events 3 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
General disorders
Injection Site Pain
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
80.0%
8/10 • Number of events 12 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
General disorders
Injection Site Pain (Tenderness)
|
60.0%
6/10 • Number of events 6 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
100.0%
10/10 • Number of events 18 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
20.0%
2/10 • Number of events 2 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
General disorders
Malaise
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
60.0%
6/10 • Number of events 6 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
30.0%
3/10 • Number of events 3 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
20.0%
2/10 • Number of events 2 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
50.0%
5/10 • Number of events 5 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
20.0%
2/10 • Number of events 2 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
40.0%
4/10 • Number of events 5 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Nervous system disorders
Headache
|
40.0%
4/10 • Number of events 4 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
40.0%
4/10 • Number of events 5 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
30.0%
3/10 • Number of events 3 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 1 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
0.00%
0/10 • For all arms, solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. For the A/H7N9 and A/H7N9 + AS03 arms, Serious Adverse Events (SAEs) and Medically Attended Adverse Events (MAAEs) were additionally collected from the time of first study vaccination through 12 months after last study vaccination.
Solicited AEs include injection site reactions and systemic reactions. Injection site reactions include pruritus, ecchymosis, erythema, induration/swelling, pain, and tenderness. Systemic reactions include fever, feverishness, fatigue, malaise, myalgia (exclusive of the injection site), arthralgia (exclusive of the injection site), headache, and nausea.
|
Additional Information
C. Buddy Creech, MD, MPH
Vanderbilt Vaccine Research Program
Phone: 615-343-0332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60