Trial Outcomes & Findings for Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4 (NCT NCT03318315)
NCT ID: NCT03318315
Last Updated: 2020-08-06
Results Overview
Blood was collected for HAI assay at conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after the second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2.
COMPLETED
PHASE2
149 participants
21 days after second dose of H7N9
2020-08-06
Participant Flow
Healthy adult participants 19-64 years of age were recruited from the communities surrounding each clinical site, and were enrolled between 20FEB2018 and 29JUN2018.
Participant milestones
| Measure |
Group 1 Simultaneous Administration
3.75 mcg HA per 0.5 mL dose of Monovalent 2017 H7N9 inactivated influenza vaccine in Phosphate Buffered Saline (PBS) diluent + GSK AS03 adjuvant and 0.5 ml dose of seasonal quadrivalent inactivated influenza vaccine (IIV4), both administered intramuscularly within 15 minutes on Day 1, and 3.75 mcg HA per 0.5 mL dose of H7N9 vaccine in PBS diluent + GSK AS03 adjuvant intramuscularly on Day 22
|
Group 2 Sequential Administration
0.5 ml dose of IIV4 vaccine intramuscularly on day 1 and 3.75 mcg HA per 0.5 ml dose of H7N9 vaccine in PBS diluent + GSK AS03 adjuvant intramuscularly on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine intramuscularly on Day 1, n=30
|
|---|---|---|---|
|
Overall Study
STARTED
|
62
|
53
|
34
|
|
Overall Study
Received First Vaccination
|
62
|
53
|
34
|
|
Overall Study
Received Second Vaccination
|
59
|
48
|
0
|
|
Overall Study
Received Third Vaccination
|
0
|
46
|
0
|
|
Overall Study
COMPLETED
|
58
|
50
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
4
|
Reasons for withdrawal
| Measure |
Group 1 Simultaneous Administration
3.75 mcg HA per 0.5 mL dose of Monovalent 2017 H7N9 inactivated influenza vaccine in Phosphate Buffered Saline (PBS) diluent + GSK AS03 adjuvant and 0.5 ml dose of seasonal quadrivalent inactivated influenza vaccine (IIV4), both administered intramuscularly within 15 minutes on Day 1, and 3.75 mcg HA per 0.5 mL dose of H7N9 vaccine in PBS diluent + GSK AS03 adjuvant intramuscularly on Day 22
|
Group 2 Sequential Administration
0.5 ml dose of IIV4 vaccine intramuscularly on day 1 and 3.75 mcg HA per 0.5 ml dose of H7N9 vaccine in PBS diluent + GSK AS03 adjuvant intramuscularly on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine intramuscularly on Day 1, n=30
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
Baseline Characteristics
Co-Administration of AS03 Adjuvanted A/H7N9 IIV With IIV4
Baseline characteristics by cohort
| Measure |
Group 1 Simultaneous Administration
n=62 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
38.0 years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
60 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
53 participants
n=7 Participants
|
34 participants
n=5 Participants
|
149 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 21 days after second dose of H7N9Population: Participants included in the modified intent-to-treat (mITT) population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for HAI assay at conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after the second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=57 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=47 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Against the 2017 H7N9 Inactivated Influenza Vaccine (IIV) Strain After Second H7N9 Vaccination
|
36.8 titer
Interval 27.7 to 48.8
|
22.7 titer
Interval 16.9 to 30.6
|
—
|
PRIMARY outcome
Timeframe: Day 22Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for HAI assay at conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=55 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=52 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=29 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains
A/Michigan/45/2015 x-275 (H1N1)
|
547.7 titer
Interval 431.0 to 696.1
|
503.6 titer
Interval 360.6 to 703.1
|
480.4 titer
Interval 290.1 to 795.7
|
|
GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains
A/Hong Kong/4801/2014 X-263B (H3N2)
|
284.0 titer
Interval 201.6 to 400.0
|
289.8 titer
Interval 202.5 to 414.7
|
462.6 titer
Interval 314.6 to 680.2
|
|
GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
20.8 titer
Interval 15.2 to 28.4
|
23.05 titer
Interval 17.3 to 31.9
|
44.4 titer
Interval 29.7 to 66.3
|
|
GMTs of Serum HAI Antibodies Against Each of the 2017 IIV4 Strains
B/Brisbane/60/2008 (B Victoria lineage)
|
46.1 titer
Interval 33.6 to 63.2
|
61.8 titer
Interval 46.0 to 82.9
|
64.1 titer
Interval 44.3 to 92.7
|
PRIMARY outcome
Timeframe: Day 22Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for the serum neutralizing antibody assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=54 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=52 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=29 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains
A/Michigan/45/2015 x-275 (H1N1)
|
230.4 titer
Interval 169.2 to 313.6
|
186.0 titer
Interval 123.0 to 281.1
|
227.6 titer
Interval 133.9 to 386.9
|
|
GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains
A/Hong Kong/4801/2014 X-263B (H3N2)
|
481.3 titer
Interval 343.7 to 674.0
|
518.4 titer
Interval 358.1 to 750.5
|
788.9 titer
Interval 584.0 to 1065.6
|
|
GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
237.9 titer
Interval 176.8 to 320.0
|
251.5 titer
Interval 193.9 to 326.2
|
452.5 titer
Interval 327.7 to 625.0
|
|
GMTs of Serum Neutralizing Antibodies Against Each of the 2017 IIV4 Strains
B/Brisbane/60/2008 (B Victoria lineage)
|
118.9 titer
Interval 90.5 to 156.3
|
157.4 titer
Interval 117.9 to 210.2
|
202.0 titer
Interval 145.0 to 281.4
|
PRIMARY outcome
Timeframe: 21 days after second dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for the serum neutralizing antibody assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results at 21 days after second dose of H7N9, which is Day 43 for Group 1 and Day 64 for Group 2.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=57 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=47 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
GMTs of Serum Neutralizing Antibodies Against the 2017 H7N9 IIV Strain After the Second H7N9 Vaccination
|
88.4 titer
Interval 63.2 to 123.9
|
50.5 titer
Interval 37.4 to 68.0
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to Day 408Population: The safety population includes all subjects receiving study product.
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All events are included regardless of relationship to the study product.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=62 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 8Population: The safety population includes all subject receiving study product with data at the time point.
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=62 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination
ALT
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination
bilirubin
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination
creatinine
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination
hemoglobin
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination
platelets
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After First Vaccination
WBC
|
5 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: The safety population includes all subject receiving study product with data at the time point.
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=47 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination
ALT
|
5 Participants
|
0 Participants
|
—
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination
bilirubin
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination
creatinine
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination
hemoglobin
|
2 Participants
|
4 Participants
|
—
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination
platelets
|
3 Participants
|
0 Participants
|
—
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Second Vaccination
WBC
|
3 Participants
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 50Population: The safety population includes all subject receiving study product with data at the time point.
Laboratory parameters include alanine aminotransferase (ALT), bilirubin, creatinine, hemoglobin, platelets and white blood cells (WBC). Thresholds for adverse events were considered as ALT 44 IU/L or greater (female) or 61 IU/L or greater (male); bilirubin 1.30 mg/dL or greater; creatinine 1.1 mg/dL or greater (female) or 1.4 mg/dL or greater (male); hemoglobin 11.4 g/dL or lower (female) or 12.4 g/dL or lower (male); platelets 139 x10\^3/µL or below or 416 x10\^3/µL or greater; or WBC or 3.9 x10\^3/µL or lower or 10.6 x10\^3/µL or higher.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=44 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination
ALT
|
0 Participants
|
—
|
—
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination
bilirubin
|
0 Participants
|
—
|
—
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination
creatinine
|
1 Participants
|
—
|
—
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination
hemoglobin
|
4 Participants
|
—
|
—
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination
platelets
|
1 Participants
|
—
|
—
|
|
Number of Participants Assessed With Clinical Safety Laboratory AEs After Third Vaccination
WBC
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to day 8Population: The safety population includes all subject receiving study product with data reported.
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (measurement grade)
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=62 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Tenderness
|
44 Participants
|
30 Participants
|
17 Participants
|
|
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Itching/Pruritus
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Ecchymosis/Bruising (functional grade)
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Ecchymosis/Bruising (measured)
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Erythema/Redness (functional grade)
|
15 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Erythema/Redness (measured)
|
14 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Pain
|
44 Participants
|
18 Participants
|
14 Participants
|
|
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Induration/Swelling (functional grade)
|
13 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site AEs After First Vaccination
Induration/Swelling (measured)
|
11 Participants
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 22 up to day 29Population: The safety population includes all subject receiving study product with data reported.
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (measurement grade)
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=48 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Pain
|
24 Participants
|
24 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Tenderness
|
32 Participants
|
32 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Itching/Pruritus
|
4 Participants
|
3 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Ecchymosis/Bruising (functional grade)
|
5 Participants
|
2 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Ecchymosis/Bruising (measured)
|
5 Participants
|
2 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Erythema/Redness (functional grade)
|
13 Participants
|
7 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Erythema/Redness (measured)
|
12 Participants
|
7 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Induration/Swelling (functional grade)
|
13 Participants
|
9 Participants
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Second Vaccination
Induration/Swelling (measured)
|
12 Participants
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 43 up to day 50Population: The safety population includes all subject receiving study product with data reported.
Injection site AEs solicited on a memory aid provided to participants included . Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days following vaccination Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with daily activities), Ecchymosis/Bruising (any measured value \>0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value \>0mm), Induration/Swelling (functional grade), and Induration/Swelling (measurement grade)
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=46 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Itching/Pruritus
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Pain
|
17 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Tenderness
|
30 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Ecchymosis/Bruising (functional grade)
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Ecchymosis/Bruising (measured)
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Erythema/Redness (functional grade)
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Erythema/Redness (measured)
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Induration/Swelling (functional grade)
|
5 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site AEs After Third Vaccination
Induration/Swelling (measured)
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 up to day 408Population: The safety population includes all subjects receiving study product.
SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. Events are included if deemed by the investigator to be related to the study product.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=62 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Occurrence of Study Vaccine-related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to day 8Population: The safety population includes all participants receiving the dose and for whom solicited data were reported
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days following vaccination.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=62 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
Elevated Oral Temperature
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
Feverishness
|
13 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
Fatigue
|
25 Participants
|
11 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
Malaise
|
19 Participants
|
6 Participants
|
8 Participants
|
|
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
Myalgia
|
28 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
Arthralgia
|
8 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
Headache
|
17 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants Reporting Solicited Systemic AEs After First Vaccination
Nausea
|
2 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 22 up to day 29Population: The safety population includes all participants receiving the dose and for whom solicited data were reported
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days following vaccination.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=48 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
Elevated Oral Temperature
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
Feverishness
|
8 Participants
|
7 Participants
|
—
|
|
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
Fatigue
|
17 Participants
|
14 Participants
|
—
|
|
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
Malaise
|
13 Participants
|
9 Participants
|
—
|
|
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
Myalgia
|
19 Participants
|
8 Participants
|
—
|
|
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
Arthralgia
|
9 Participants
|
5 Participants
|
—
|
|
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
Headache
|
13 Participants
|
8 Participants
|
—
|
|
Number of Participating Reporting Solicited Systemic AEs After Second Vaccination
Nausea
|
6 Participants
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: Day 43 up to day 50Population: The safety population includes all participants receiving the dose and for whom solicited data were reported
Systemic AEs solicited on a memory aid provided to participants included Elevated Oral Temperature, Feverishness, Fatigue, Malaise, Myalgia, Arthralgia, Headache, and Nausea. Participants are considered reporting the systemic AE if they reported mild or greater severity at any time during the 8 days following vaccination.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=46 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
Elevated Oral Temperature
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
Feverishness
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
Fatigue
|
10 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
Malaise
|
5 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
Myalgia
|
11 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
Arthralgia
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
Headache
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Systemic AEs After Third Vaccination
Nausea
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 days after second dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer = / \>1:40 or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=57 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=47 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination
|
51 percentage of participants
Interval 37.0 to 64.0
|
38 percentage of participants
Interval 25.0 to 54.0
|
—
|
PRIMARY outcome
Timeframe: 21 days after second dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for the serum neutralizing antibody assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as neutralizing antibody pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=57 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=47 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against 2017 H7N9 Study Vaccine After Second H7N9 Vaccination
|
82 percentage of participants
Interval 70.0 to 91.0
|
74 percentage of participants
Interval 60.0 to 86.0
|
—
|
PRIMARY outcome
Timeframe: Day 22Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for the HAI assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer = / \>1:40 or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=29 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains
A/Michigan/45/2015 x-275 (H1N1)
|
53 percentage of participants
Interval 39.0 to 66.0
|
58 percentage of participants
Interval 44.0 to 72.0
|
55 percentage of participants
Interval 36.0 to 74.0
|
|
Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains
A/Hong Kong/4801/2014 X-263B (H3N2)
|
49 percentage of participants
Interval 36.0 to 63.0
|
55 percentage of participants
Interval 40.0 to 68.0
|
72 percentage of participants
Interval 53.0 to 87.0
|
|
Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
19 percentage of participants
Interval 10.0 to 31.0
|
13 percentage of participants
Interval 5.0 to 25.0
|
41 percentage of participants
Interval 24.0 to 61.0
|
|
Percentage of Participants Achieving HAI Seroconversion Against Each of the Study IIV4 Strains
B/Brisbane/60/2008 (B Victoria lineage)
|
29 percentage of participants
Interval 18.0 to 42.0
|
47 percentage of participants
Interval 33.0 to 61.0
|
48 percentage of participants
Interval 29.0 to 67.0
|
PRIMARY outcome
Timeframe: Day 22Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for the HAI assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=29 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
A/Michigan/45/2015 x-275 (H1N1)
|
100 percentage of participants
Interval 94.0 to 100.0
|
96 percentage of participants
Interval 87.0 to 100.0
|
93 percentage of participants
Interval 77.0 to 99.0
|
|
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
A/Hong Kong/4801/2014 X-263B (H3N2)
|
93 percentage of participants
Interval 84.0 to 98.0
|
94 percentage of participants
Interval 84.0 to 99.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
|
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
25 percentage of participants
Interval 15.0 to 38.0
|
30 percentage of participants
Interval 18.0 to 44.0
|
62 percentage of participants
Interval 42.0 to 79.0
|
|
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
B/Brisbane/60/2008 (B Victoria lineage)
|
54 percentage of participants
Interval 41.0 to 67.0
|
72 percentage of participants
Interval 58.0 to 83.0
|
76 percentage of participants
Interval 56.0 to 90.0
|
PRIMARY outcome
Timeframe: 21 days after second dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for the HAI assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after second dose of H7N9 is Day 43 for Group 1 and Day 64 for Group 2
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=57 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=47 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants With HAI Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination
|
51 percentage of participants
Interval 37.0 to 64.0
|
38 percentage of participants
Interval 25.0 to 54.0
|
—
|
PRIMARY outcome
Timeframe: Day 22Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for the serum neutralizing antibody assay conducted with the IIV4 vaccine viruses as the antigens. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=58 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=29 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
A/Michigan/45/2015 x-275 (H1N1)
|
98 percentage of participants
Interval 91.0 to 100.0
|
85 percentage of participants
Interval 72.0 to 93.0
|
93 percentage of participants
Interval 77.0 to 99.0
|
|
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
A/Hong Kong/4801/2014 X-263B (H3N2)
|
93 percentage of participants
Interval 84.0 to 98.0
|
94 percentage of participants
Interval 84.0 to 99.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
|
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
B/Phuket/3073/2013 (B Yamagata lineage)
|
95 percentage of participants
Interval 86.0 to 99.0
|
100 percentage of participants
Interval 93.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
|
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against Each of the Study IIV4 Strains
B/Brisbane/60/2008 (B Victoria lineage)
|
90 percentage of participants
Interval 79.0 to 96.0
|
96 percentage of participants
Interval 87.0 to 100.0
|
100 percentage of participants
Interval 88.0 to 100.0
|
PRIMARY outcome
Timeframe: 21 days after second dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for the serum neutralizing antibody assay conducted with the 2017 H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after second dose of H7N9 is Day 43 for Group 1 and Day 64 for Group 2
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=57 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=47 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants With Neutralizing Antibody Titer of 1:40 or Greater Against the Influenza 2017 H7N9 Study Vaccine Strain After Second H7N9 Vaccination
|
84 percentage of participants
Interval 72.0 to 93.0
|
74 percentage of participants
Interval 60.0 to 86.0
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline
|
5.7 titer
Interval 5.5 to 6.0
|
5.7 titer
Interval 5.3 to 6.1
|
—
|
SECONDARY outcome
Timeframe: 21 days after first dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=57 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=50 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
GMTs of Serum HAI Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination
|
9.9 titer
Interval 7.7 to 12.7
|
6.6 titer
Interval 5.9 to 7.4
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for the serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=60 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus at Baseline
|
5.9 titer
Interval 5.4 to 6.6
|
5.4 titer
Interval 5.1 to 5.7
|
—
|
SECONDARY outcome
Timeframe: 21 days after first dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. The geometric mean titer was calculated for each study arm from the available results. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=50 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
GMTs of Serum Neutralizing Antibodies Against the Influenza 2017 H7N9 Vaccine Virus After First H7N9 Vaccination
|
22.3 titer
Interval 16.2 to 30.8
|
18.4 titer
Interval 14.5 to 23.4
|
—
|
SECONDARY outcome
Timeframe: Approximately 21 days after first vaccinationPopulation: The safety population includes all participants receiving the vaccination.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=62 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Any SOC
|
18 Participants
|
11 Participants
|
4 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Blood And Lymphatic System Disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Eye Disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Gastrointestinal Disorders
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
General Disorders / Administration Site Conditions
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Infections And Infestations
|
8 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Injury, Poisoning And Procedural Complications
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Investigations
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Musculoskeletal And Connective Tissue Disorders
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Nervous System Disorders
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Psychiatric Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Reproductive System And Breast Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Respiratory, Thoracic And Mediastinal Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After First Vaccination
Vascular Disorders
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 21 days after second vaccinationPopulation: The safety population includes all participants who received the vaccination.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=48 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
Gastrointestinal Disorders
|
2 Participants
|
1 Participants
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
General Disorders / Administration Site Conditions
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
Infections And Infestations
|
5 Participants
|
2 Participants
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
Injury, Poisoning And Procedural Complications
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
Investigations
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
Musculoskeletal And Connective Tissue Disorders
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
Nervous System Disorders
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
Psychiatric Disorders
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Second Vaccination
Any SOC
|
12 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Approximately 21 days after third vaccinationPopulation: The safety population includes all participants who received the vaccination.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=46 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination
Any SOC
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination
General Disorders / Administration Site Conditions
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination
Investigations
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination
Musculoskeletal And Connective Tissue Disorders
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Unsolicited Non-serious AEs After Third Vaccination
Nervous System Disorders
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 up to day 408Population: The safety population included all participants who received at least one dose of study product.
Participants were queried at each visit for the occurrence of medically-attended adverse events (MAAEs), including new-onset chronic medical conditions (NOCMCs) and potentially immune-mediated medical conditions (PIMMCs) throughout the duration of the study.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=62 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs)
MAAE
|
6 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs)
NOCMC
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting of Medically-Attended Adverse Events (MAAEs), Including New-Onset Chronic Medical Conditions (NOCMCs) and Potentially Immune-Mediated Medical Conditions (PIMMCs)
PIMMC
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 21 days after first vaccinationPopulation: The safety population includes all participants receiving the vaccination.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as "a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE." Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=62 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 Participants
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
Infections And Infestations
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
Any SOC
|
7 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
Gastrointestinal Disorders
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
General Disorders / Administration Site Conditions
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
Investigations
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
Nervous System Disorders
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
Psychiatric Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After First Vaccination
Respiratory, Thoracic And Mediastinal Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximately 21 days after second vaccinationPopulation: The safety population includes all participants receiving the vaccination.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as "a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE." Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=48 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination
Gastrointestinal Disorders
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination
General Disorders / Administration Site Conditions
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination
Infections And Infestations
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination
Any SOC
|
3 Participants
|
3 Participants
|
—
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination
Musculoskeletal And Connective Tissue Disorders
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Second Vaccination
Nervous System Disorders
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Approximately 21 days after third vaccinationPopulation: The safety population includes all participants receiving the vaccination.
Adverse events were defined as any untoward medical occurrence in a participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Non-serious AEs were collected from participants at follow up visits through approximately 21 days after each vaccination. The site investigator determined vaccine related as "a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE." Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=46 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Third Vaccination
Any SOC
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Third Vaccination
Investigations
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious AEs After Third Vaccination
Nervous System Disorders
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days after first dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as HAI pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=57 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=50 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants Achieving HAI Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
|
14 percentage of participants
Interval 6.0 to 26.0
|
2 percentage of participants
Interval 0.0 to 11.0
|
—
|
SECONDARY outcome
Timeframe: 21 days after first dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. Seroconversion was defined as a pre-vaccination titer \<1:10 and post-vaccination titer 1:40 or greater, or pre-vaccination titer 1:10 or greater and min. 4-fold rise in post-vaccination antibody titer. 21 days after first dose of H7N9 is Day 22 for Group 1 and Day 43 for Group 2.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=50 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants Achieving Neutralizing Antibody Seroconversion Against the 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
|
34 percentage of participants
Interval 22.0 to 47.0
|
28 percentage of participants
Interval 16.0 to 42.0
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for HAI assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline
|
0 percentage of participants
Interval 0.0 to 6.0
|
0 percentage of participants
Interval 0.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: 21 days after first dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after first H7N9 vaccination was Day 22 for Group 1 and Day 43 for Group 2
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=57 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=50 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants Achieving Serum HAI Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
|
14 percentage of participants
Interval 6.0 to 26.0
|
2 percentage of participants
Interval 0.0 to 11.0
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result.
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=60 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain at Baseline
|
2 percentage of participants
Interval 0.0 to 9.0
|
0 percentage of participants
Interval 0.0 to 7.0
|
—
|
SECONDARY outcome
Timeframe: 21 days after first dose of H7N9Population: Participants included in the mITT population are those who received the first study dose have immunogenicity results at baseline and at least one timepoint post baseline. If baseline results are unavailable for an assay at baseline, the participant is not included in mITT analysis at any timepoint for that assay only.
Blood was collected for serum neutralizing antibody assay at conducted with the H7N9 vaccine virus as the antigen. Each sample was tested at least twice per the laboratory's standard operating procedure, and the geometric mean of the replicate results was calculated as that sample's result. 21 days after first H7N9 vaccination was Day 22 for Group 1 and Day 43 for Group 2
Outcome measures
| Measure |
Group 1 Simultaneous Administration
n=59 Participants
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=50 Participants
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Percentage of Participants Achieving Serum Neutralizing Antibody Titers of 1:40 or Greater Against the Influenza 2017 H7N9 Vaccine Strain After First H7N9 Vaccination
|
34 percentage of participants
Interval 22.0 to 47.0
|
28 percentage of participants
Interval 16.0 to 42.0
|
—
|
Adverse Events
Group 1 Simultaneous Administration
Group 2 Sequential Administration
Group 3 IIV4 Only
Serious adverse events
| Measure |
Group 1 Simultaneous Administration
n=62 participants at risk
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 participants at risk
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 participants at risk
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/62 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
1.9%
1/53 • Number of events 1 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
0.00%
0/34 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
Other adverse events
| Measure |
Group 1 Simultaneous Administration
n=62 participants at risk
3.75 mcg HA of H7N9 IIV in PBS + GSK AS03 adjuvant and 0.5 ml IIV4, both administered IM within 15 minutes on Day 1, and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22
|
Group 2 Sequential Administration
n=53 participants at risk
0.5 ml dose of IIV4 vaccine IM on day 1 and 3.75 mcg HA of H7N9 vaccine in PBS + GSK AS03 adjuvant IM on Day 22 and Day 43
|
Group 3 IIV4 Only
n=34 participants at risk
0.5 ml dose of IIV4 vaccine IM on Day 1, n=30
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.3%
7/62 • Number of events 8 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
15.1%
8/53 • Number of events 10 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
14.7%
5/34 • Number of events 5 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
General disorders
Fatigue
|
43.5%
27/62 • Number of events 42 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
43.4%
23/53 • Number of events 37 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
20.6%
7/34 • Number of events 7 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
General disorders
Feeling hot
|
27.4%
17/62 • Number of events 21 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
17.0%
9/53 • Number of events 9 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
8.8%
3/34 • Number of events 3 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
General disorders
Injection site erythema
|
32.3%
20/62 • Number of events 38 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
24.5%
13/53 • Number of events 16 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
11.8%
4/34 • Number of events 4 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
General disorders
Injection site haemorrhage
|
12.9%
8/62 • Number of events 9 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
9.4%
5/53 • Number of events 6 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
2.9%
1/34 • Number of events 1 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
General disorders
Injection site induration
|
30.6%
19/62 • Number of events 30 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
30.2%
16/53 • Number of events 19 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
0.00%
0/34 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
General disorders
Injection site pain
|
77.4%
48/62 • Number of events 106 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
75.5%
40/53 • Number of events 92 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
50.0%
17/34 • Number of events 17 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
General disorders
Injection site pruritus
|
14.5%
9/62 • Number of events 9 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
11.3%
6/53 • Number of events 7 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
5.9%
2/34 • Number of events 2 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
General disorders
Malaise
|
38.7%
24/62 • Number of events 32 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
28.3%
15/53 • Number of events 20 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
23.5%
8/34 • Number of events 8 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.1%
5/62 • Number of events 7 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
1.9%
1/53 • Number of events 1 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
2.9%
1/34 • Number of events 1 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Investigations
Alanine aminotransferase increased
|
8.1%
5/62 • Number of events 11 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
1.9%
1/53 • Number of events 3 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
0.00%
0/34 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Investigations
Blood creatinine increased
|
6.5%
4/62 • Number of events 6 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
3.8%
2/53 • Number of events 3 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
0.00%
0/34 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Investigations
Body temperature increased
|
1.6%
1/62 • Number of events 1 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
1.9%
1/53 • Number of events 1 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
5.9%
2/34 • Number of events 2 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Investigations
Haemoglobin decreased
|
6.5%
4/62 • Number of events 11 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
15.1%
8/53 • Number of events 24 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
8.8%
3/34 • Number of events 3 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Investigations
Platelet count increased
|
6.5%
4/62 • Number of events 8 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
3.8%
2/53 • Number of events 3 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
0.00%
0/34 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Investigations
White blood cell count decreased
|
6.5%
4/62 • Number of events 4 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
18.9%
10/53 • Number of events 24 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
0.00%
0/34 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Investigations
White blood cell count increased
|
14.5%
9/62 • Number of events 12 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
9.4%
5/53 • Number of events 9 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
5.9%
2/34 • Number of events 2 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.0%
13/62 • Number of events 17 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
17.0%
9/53 • Number of events 13 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
11.8%
4/34 • Number of events 4 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
53.2%
33/62 • Number of events 47 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
32.1%
17/53 • Number of events 26 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
26.5%
9/34 • Number of events 9 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
|
Nervous system disorders
Headache
|
43.5%
27/62 • Number of events 32 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
28.3%
15/53 • Number of events 20 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
23.5%
8/34 • Number of events 8 • Solicited events were collected for 7 days after each vaccination, unsolicited non-serious AEs through 21 days after each vaccination, and SAEs through approximately 1 year after the last study vaccination.
For events solicited on the Memory Aid in the 7 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 7-day period. Each 7-day period was considered a separate event.
|
Additional Information
Kathleen M. Neuzil, MD, MPH
University of Maryland School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60