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Sanofi 2017 H7N9 With/Without AS03 in Adults/Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03312231
Recruitment Status : Completed
First Posted : October 17, 2017
Results First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Avian Influenza
Influenza Immunisation
Interventions Drug: AS03
Biological: Inactivated influenza H7N9 vaccine
Other: Phosphate Buffered Saline (PBS) diluent
Enrollment 720
Recruitment Details Participants were healthy males and non-pregnant females aged 19 years and older recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 14FEB2018 and 05SEP2018.
Pre-assignment Details  
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22.

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Period Title: Overall Study
Started [1] 184 176 181 89 90
Completed 181 165 177 86 89
Not Completed 3 11 4 3 1
Reason Not Completed
Lost to Follow-up             2             6             1             3             1
Withdrawal by Subject             0             3             1             0             0
Death             0             1             1             0             0
Study Vaccination not Received             1             1             1             0             0
[1]
One subject allocated to Group 4 and received Group 5 treatment due to error was analyzed as Group 5
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5 Total
Hide Arm/Group Description

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Total of all reporting groups
Overall Number of Baseline Participants 183 175 180 89 90 717
Hide Baseline Analysis Population Description
The baseline analysis population includes all participants who received at least one dose of study vaccine.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 183 participants 175 participants 180 participants 89 participants 90 participants 717 participants
52.7  (20.0) 51.2  (20.0) 51.5  (20.2) 53.2  (18.6) 51.9  (19.0) 52.0  (19.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 175 participants 180 participants 89 participants 90 participants 717 participants
Female
94
  51.4%
99
  56.6%
81
  45.0%
47
  52.8%
50
  55.6%
371
  51.7%
Male
89
  48.6%
76
  43.4%
99
  55.0%
42
  47.2%
40
  44.4%
346
  48.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 175 participants 180 participants 89 participants 90 participants 717 participants
Hispanic or Latino
4
   2.2%
4
   2.3%
9
   5.0%
7
   7.9%
6
   6.7%
30
   4.2%
Not Hispanic or Latino
179
  97.8%
169
  96.6%
170
  94.4%
82
  92.1%
84
  93.3%
684
  95.4%
Unknown or Not Reported
0
   0.0%
2
   1.1%
1
   0.6%
0
   0.0%
0
   0.0%
3
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 183 participants 175 participants 180 participants 89 participants 90 participants 717 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
1
   1.1%
2
   0.3%
Asian
7
   3.8%
8
   4.6%
14
   7.8%
1
   1.1%
3
   3.3%
33
   4.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
19
  10.4%
22
  12.6%
25
  13.9%
13
  14.6%
10
  11.1%
89
  12.4%
White
149
  81.4%
137
  78.3%
130
  72.2%
69
  77.5%
73
  81.1%
558
  77.8%
More than one race
6
   3.3%
5
   2.9%
7
   3.9%
4
   4.5%
2
   2.2%
24
   3.3%
Unknown or Not Reported
2
   1.1%
3
   1.7%
4
   2.2%
1
   1.1%
1
   1.1%
11
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 183 participants 175 participants 180 participants 89 participants 90 participants 717 participants
183 175 180 89 90 717
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 183 participants 175 participants 180 participants 89 participants 90 participants 717 participants
27.5  (5.3) 28.2  (6.5) 26.8  (5.4) 27.2  (5.8) 27.5  (4.3) 27.5  (5.6)
1.Primary Outcome
Title Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Hide Description Blood was collected for HAI assay which was 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.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 179 172 180 87 88
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
33.6
(27.8 to 40.7)
33.5
(27.9 to 40.2)
39.2
(32.6 to 47.0)
5.5
(5.3 to 5.7)
6.3
(5.7 to 6.9)
2.Primary Outcome
Title Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Hide Description Blood was collected for Neutralizing assay which was 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.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 179 173 180 87 88
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
45.2
(38.4 to 53.2)
46.1
(39.5 to 53.9)
49.7
(42.5 to 58.1)
6.2
(5.7 to 6.8)
7.8
(6.8 to 9.0)
3.Primary Outcome
Title Number of Participants With Clinical Safety Laboratory Adverse Events
Hide Description 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.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine. Participants who completed Day 8 visit were included for this outcome measure.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 182 173 179 88 90
Measure Type: Count of Participants
Unit of Measure: Participants
WBC
8
   4.4%
18
  10.4%
16
   8.9%
6
   6.8%
5
   5.6%
Hemoglobin
4
   2.2%
5
   2.9%
3
   1.7%
8
   9.1%
5
   5.6%
Platelets
4
   2.2%
7
   4.0%
1
   0.6%
2
   2.3%
3
   3.3%
ALT
3
   1.6%
5
   2.9%
3
   1.7%
1
   1.1%
1
   1.1%
Total Bilirubin
0
   0.0%
3
   1.7%
2
   1.1%
4
   4.5%
1
   1.1%
Creatinine
2
   1.1%
5
   2.9%
4
   2.2%
2
   2.3%
3
   3.3%
4.Primary Outcome
Title Number of Participants With Clinical Safety Laboratory Adverse Events
Hide Description 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.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine. Participants who completed Day 29 visit were included for this outcome measure.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 169 156 169 83 78
Measure Type: Count of Participants
Unit of Measure: Participants
WBC
10
   5.9%
14
   9.0%
14
   8.3%
7
   8.4%
4
   5.1%
Hemoglobin
7
   4.1%
8
   5.1%
5
   3.0%
6
   7.2%
3
   3.8%
Platelets
3
   1.8%
2
   1.3%
2
   1.2%
1
   1.2%
3
   3.8%
ALT
2
   1.2%
3
   1.9%
2
   1.2%
1
   1.2%
0
   0.0%
Total Bilirubin
2
   1.2%
5
   3.2%
2
   1.2%
0
   0.0%
1
   1.3%
Creatinine
2
   1.2%
4
   2.6%
3
   1.8%
2
   2.4%
3
   3.8%
5.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site Events
Hide Description Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with dailyactivities), Ecchymosis/Bruising (any measured value >0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value >0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value >0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the first vaccination.
Time Frame Day 1 to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 175 180 89 90
Measure Type: Count of Participants
Unit of Measure: Participants
145
  79.2%
153
  87.4%
154
  85.6%
36
  40.4%
46
  51.1%
6.Primary Outcome
Title Number of Participants Reporting Solicited Injection Site Events
Hide Description Injection site AEs solicited on a memory aid provided to participants included Pain, Tenderness, Itching/Pruritus, Ecchymosis/Bruising (functional grade based on interference with dailyactivities), Ecchymosis/Bruising (any measured value >0mm), Erythema/Redness (functional grade), Erythema/ Redness (any measured value >0mm), Induration/Swelling (functional grade), and Induration/Swelling (any measured value >0mm). Participants are considered reporting the injection site AE if they reported mild or greater severity at any time during the 8 days at or following the second vaccination.
Time Frame Day 22 to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 173 157 170 84 78
Measure Type: Count of Participants
Unit of Measure: Participants
122
  70.5%
116
  73.9%
140
  82.4%
35
  41.7%
33
  42.3%
7.Primary Outcome
Title Number of Participants Reporting Study Vaccine-related Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Day 1 to Day 387
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 175 180 89 90
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Participants Reporting Systemic Reactogenicity Events
Hide Description 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 at or following the first vaccination.
Time Frame Day 1 to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 175 180 89 90
Measure Type: Count of Participants
Unit of Measure: Participants
76
  41.5%
81
  46.3%
72
  40.0%
27
  30.3%
31
  34.4%
9.Primary Outcome
Title Number of Participants Reporting Systemic Reactogenicity Events
Hide Description 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 at or following the second vaccination.
Time Frame Day 22 to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 173 157 170 84 78
Measure Type: Count of Participants
Unit of Measure: Participants
75
  43.4%
64
  40.8%
72
  42.4%
19
  22.6%
17
  21.8%
10.Primary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titer of 1:40 or Greater
Hide Description 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. The percentage of participants with HAI titer >= 1:40 was calculated for each study group from the available results at 21 days after second dose of H7N9.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 179 172 180 87 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57
(49 to 64)
56
(49 to 64)
61
(54 to 68)
0
(0 to 4)
2
(0 to 8)
11.Primary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titer of 1:40 or Greater
Hide Description Blood was collected for the Neutralizing 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 percentage of participants with Neut titer >= 1:40 was calculated for each study group from the available results at 21 days after second dose of H7N9.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 179 173 180 87 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
64
(56 to 71)
65
(57 to 72)
68
(60 to 75)
0
(0 to 4)
3
(1 to 10)
12.Primary Outcome
Title Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies
Hide Description 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 minimum 4-fold rise in post-vaccination antibody titer. 21 days after second dose of H7N9 is Day 43.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 179 172 180 87 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56
(49 to 64)
56
(49 to 64)
61
(54 to 68)
0
(0 to 4)
2
(0 to 8)
13.Primary Outcome
Title Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies
Hide Description Blood was collected for the Neutralizing 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >=1:40 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 43.
Time Frame Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 179 173 180 87 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64
(56 to 71)
64
(56 to 71)
67
(60 to 74)
0
(0 to 4)
2
(0 to 8)
14.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Hide Description Blood was collected for HAI assay which was 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 baseline.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 174 180 88 90
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
5.2
(5.1 to 5.3)
5.2
(5.1 to 5.3)
5.2
(5.1 to 5.3)
5.3
(5.1 to 5.4)
5.4
(5.1 to 5.6)
15.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Hide Description Blood was collected for HAI assay which was 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 7 days post first vaccination.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 173 180 88 90
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
5.3
(5.1 to 5.5)
5.6
(5.2 to 6.1)
5.8
(5.5 to 6.2)
5.3
(5.1 to 5.5)
6.0
(5.2 to 6.9)
16.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Hide Description Blood was collected for HAI assay which was 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 post first vaccination.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 182 173 179 87 90
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
6.7
(6.2 to 7.3)
7.0
(6.4 to 7.7)
7.6
(6.9 to 8.5)
5.5
(5.2 to 5.9)
6.0
(5.2 to 6.9)
17.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies
Hide Description Blood was collected for HAI assay which was 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 7 days post second vaccination.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 171 155 170 83 78
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
36.7
(29.9 to 45.2)
45.1
(37.1 to 54.9)
45.7
(37.6 to 55.5)
5.4
(5.2 to 5.6)
6.8
(6.0 to 7.7)
18.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Hide Description Blood was collected for Neutralizing assay which was 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 baseline.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 174 180 88 90
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
5.2
(5.1 to 5.4)
5.3
(5.1 to 5.5)
5.3
(5.2 to 5.5)
5.3
(5.1 to 5.6)
5.5
(5.1 to 6.0)
19.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Hide Description Blood was collected for Neutralizing assay which was 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 7 days post first vaccination.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 173 180 88 90
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
5.6
(5.4 to 5.8)
6.4
(5.8 to 7.0)
6.6
(6.1 to 7.1)
5.5
(5.2 to 5.8)
6.3
(5.5 to 7.3)
20.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Hide Description Blood was collected for Neutralizing assay which was 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 post first vaccination.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 182 172 179 87 90
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
8.4
(7.7 to 9.2)
9.1
(8.1 to 10.2)
9.9
(8.8 to 11.1)
5.4
(5.2 to 5.6)
6.9
(5.9 to 8.0)
21.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Serum Neutralizing (Neut) Antibodies
Hide Description Blood was collected for Neutralizing assay which was 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 7 days post second vaccination.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 172 156 168 83 78
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
43.6
(36.5 to 52.2)
53.9
(45.6 to 63.6)
54.7
(46.1 to 64.9)
6.1
(5.6 to 6.6)
8.1
(6.9 to 9.5)
22.Secondary Outcome
Title Number of Participants Reporting Serious Adverse Events (SAEs), Regardless of the Assessment of Relatedness
Hide Description 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.
Time Frame Day 1 to Day 387
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 175 180 89 90
Measure Type: Count of Participants
Unit of Measure: Participants
4
   2.2%
9
   5.1%
4
   2.2%
3
   3.4%
1
   1.1%
23.Secondary Outcome
Title Number of Participants Reporting Unsolicited Adverse Events (AEs), Regardless of the Assessment of Seriousness or Relatedness
Hide Description 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 21 days after each vaccination. Adverse events were MedDRA coded and are summarized by MedDRA System Organ Class (SOC).
Time Frame Day 1 to Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 175 180 89 90
Measure Type: Count of Participants
Unit of Measure: Participants
72
  39.3%
62
  35.4%
67
  37.2%
23
  25.8%
27
  30.0%
24.Secondary Outcome
Title Number of Participants Reporting Medically-attended Adverse Events (MAAEs), New-onset Chronic Medical Conditions (NOCMCs), and Potentially Immune-mediated Medical Conditions (PIMMCs)
Hide Description For each unsolicited AE experienced, the participants were asked if he/she had received medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. AEs characterized by such unscheduled medical care were designated as MAAEs. NOCMCs are defined as any new ICD-10 diagnosis that is applied to the participant during the duration of the study, after receipt of the study agent, that is expected to continue for at least 3 months and requires continued health care intervention. PIMMCs constitute a group of AEs that includes diseases which are clearly autoimmune in etiology and other inflammatory and/or neurologic disorders which may or may not have autoimmune etiologies.
Time Frame Day 1 to Day 387
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 175 180 89 90
Measure Type: Count of Participants
Unit of Measure: Participants
Medically-Attended Adverse Events
69
  37.7%
59
  33.7%
65
  36.1%
33
  37.1%
25
  27.8%
New-Onset Chronic Medical Conditions
17
   9.3%
7
   4.0%
7
   3.9%
7
   7.9%
4
   4.4%
Potentially Immune-Mediated Medical Conditions
2
   1.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
25.Secondary Outcome
Title Number of Participants Reporting Study Vaccine-related Unsolicited Non-serious Adverse Events (AEs)
Hide Description 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 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).
Time Frame Day 1 to Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis population includes all participants who received at least one dose of study vaccine.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 175 180 89 90
Measure Type: Count of Participants
Unit of Measure: Participants
19
  10.4%
14
   8.0%
12
   6.7%
4
   4.5%
4
   4.4%
26.Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater
Hide Description 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. The percentage of participants with HAI titer >= 1:40 was calculated for each study group from the available results at baseline.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 174 180 88 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 2)
0
(0 to 2)
0
(0 to 2)
0
(0 to 4)
0
(0 to 4)
27.Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater
Hide Description 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. The percentage of participants with HAI titer >= 1:40 was calculated for each study group from the available results at 7 days post first vaccination.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 173 180 88 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1
(0 to 3)
2
(0 to 5)
2
(1 to 6)
0
(0 to 4)
2
(0 to 8)
28.Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater
Hide Description 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. The percentage of participants with HAI titer >= 1:40 was calculated for each study group from the available results at 21 days post first vaccination.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 182 173 179 87 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3
(1 to 7)
5
(2 to 10)
7
(4 to 11)
1
(0 to 6)
2
(0 to 8)
29.Secondary Outcome
Title Percentage of Participants Achieving Hemagglutination Inhibition (HAI) Antibodies Titers of 1:40 or Greater
Hide Description 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. The percentage of participants with HAI titer >= 1:40 was calculated for each study group from the available results at 7 days post second vaccination.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 171 155 170 83 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
57
(49 to 64)
65
(57 to 73)
64
(56 to 71)
0
(0 to 4)
5
(1 to 13)
30.Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater
Hide Description Blood was collected for the Neutralizing 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 percentage of participants with Neut titer >= 1:40 was calculated for each study group from the available results at baseline.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 174 180 88 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 2)
1
(0 to 3)
0
(0 to 2)
0
(0 to 4)
1
(0 to 6)
31.Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater
Hide Description 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. The percentage of participants with HAI titer >= 1:40 was calculated for each study group from the available results at 7 days post first vaccination.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 173 180 88 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 2)
3
(1 to 7)
2
(0 to 5)
0
(0 to 4)
3
(1 to 9)
32.Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater
Hide Description Blood was collected for the Neutralizing 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 percentage of participants with Neut titer >= 1:40 was calculated for each study group from the available results at 21 days post first vaccination.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 182 172 179 87 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2
(1 to 6)
5
(2 to 10)
6
(3 to 11)
0
(0 to 4)
3
(1 to 9)
33.Secondary Outcome
Title Percentage of Participants Achieving Neutralizing (Neut) Antibodies Titers of 1:40 or Greater
Hide Description Blood was collected for the Neutralizing 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 percentage of participants with Neut titer >= 1:40 was calculated for each study group from the available results at 7 days post second vaccination.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 172 156 168 83 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61
(53 to 68)
71
(63 to 78)
67
(60 to 74)
0
(0 to 4)
6
(2 to 14)
34.Secondary Outcome
Title Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies
Hide Description 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 minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days after the first dose of H7N9.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 173 180 88 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 2)
1
(0 to 4)
2
(1 to 6)
0
(0 to 4)
2
(0 to 8)
35.Secondary Outcome
Title Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies
Hide Description 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 minimum 4-fold rise in post-vaccination antibody titer. Day 22 is 21 days after the first dose of H7N9.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 182 173 179 87 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3
(1 to 6)
5
(2 to 10)
7
(4 to 11)
1
(0 to 6)
2
(0 to 8)
36.Secondary Outcome
Title Percentage of Participants Achieving Seroconversion Defined by Hemagglutination Inhibition (HAI) Antibodies
Hide Description 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 minimum 4-fold rise in post-vaccination antibody titer. Day 29 is 7 days after the second dose of H7N9.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for HAI antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 171 155 170 83 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56
(48 to 64)
65
(57 to 73)
64
(56 to 71)
0
(0 to 4)
5
(1 to 13)
37.Secondary Outcome
Title Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies
Hide Description Blood was collected for the Neutralizing 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >=1:40 or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 8 is 7 days after the first dose of H7N9.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 183 173 180 88 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 2)
2
(1 to 6)
2
(0 to 5)
0
(0 to 4)
2
(0 to 8)
38.Secondary Outcome
Title Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies
Hide Description Blood was collected for the Neutralizing 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >=1:40 or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 22 is 21 days after the first dose of H7N9.
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 182 172 179 87 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2
(0 to 5)
5
(2 to 9)
6
(3 to 11)
0
(0 to 4)
2
(0 to 8)
39.Secondary Outcome
Title Percentage of Participants Achieving Seroconversion Defined by Neutralizing (Neut) Antibodies
Hide Description Blood was collected for the Neutralizing 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 Neut pre-vaccination titer <1:10 and post-vaccination titer >=1:40 or pre-vaccination titer 1:10 or greater and minimum 4-fold rise in post-vaccination antibody titer. Day 29 is 7 days after the second dose of H7N9.
Time Frame Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) population includes all participants who received at least one study vaccination and contributed both pre- and at least one post-study vaccination venous blood samples for Neut antibody assays for which valid results were reported.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

Overall Number of Participants Analyzed 172 156 168 83 78
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
60
(53 to 68)
70
(62 to 77)
67
(59 to 74)
0
(0 to 4)
6
(2 to 14)
Time Frame Solicited events were collected from the time of each study vaccination through 7 days after each study vaccination. Unsolicited non-serious AEs were collected from the time of each study vaccination through approximately 21 days after each study vaccination. SAEs and MAAEs, including NOCMCs and PIMMCs, were collected from the time of the first study vaccination through the final study visit, approximately 12 months after the last study vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description

3.75 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

7.5 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of H7N9 vaccine plus AS03 adjuvant on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

AS03: Oil-in-water emulsion based adjuvant system.

15 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

45 mcg of unadjuvanted H7N9 vaccine on days 1 and 22

Inactivated influenza H7N9 vaccine: Monovalent 2017 H7N9 inactivated influenza vaccine

All-Cause Mortality
Group 1 Group 2 Group 3 Group 4 Group 5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/183 (0.55%)      1/175 (0.57%)      1/180 (0.56%)      0/89 (0.00%)      0/90 (0.00%)    
Hide Serious Adverse Events
Group 1 Group 2 Group 3 Group 4 Group 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/183 (2.19%)      9/175 (5.14%)      4/180 (2.22%)      3/89 (3.37%)      1/90 (1.11%)    
Cardiac disorders           
Acute coronary syndrome  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Angina unstable  1  1/183 (0.55%)  1 0/175 (0.00%)  0 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Stress cardiomyopathy  1  0/183 (0.00%)  0 0/175 (0.00%)  0 0/180 (0.00%)  0 0/89 (0.00%)  0 1/90 (1.11%)  1
Gastrointestinal disorders           
Small intestinal obstruction  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
General disorders           
Chest pain  1  1/183 (0.55%)  1 0/175 (0.00%)  0 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Hepatobiliary disorders           
Cholelithiasis  1  0/183 (0.00%)  0 0/175 (0.00%)  0 1/180 (0.56%)  1 0/89 (0.00%)  0 0/90 (0.00%)  0
Infections and infestations           
Bacteraemia  1  0/183 (0.00%)  0 0/175 (0.00%)  0 0/180 (0.00%)  0 1/89 (1.12%)  1 0/90 (0.00%)  0
Epididymitis  1  0/183 (0.00%)  0 0/175 (0.00%)  0 0/180 (0.00%)  0 1/89 (1.12%)  1 0/90 (0.00%)  0
Injury, poisoning and procedural complications           
Contusion  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Fall  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Femur fracture  1  1/183 (0.55%)  1 0/175 (0.00%)  0 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Back pain  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Intervertebral disc protrusion  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Lumbar spinal stenosis  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Cholangiocarcinoma  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Diffuse large B-cell lymphoma  1  0/183 (0.00%)  0 0/175 (0.00%)  0 0/180 (0.00%)  0 1/89 (1.12%)  1 0/90 (0.00%)  0
Hepatobiliary cancer  1  0/183 (0.00%)  0 0/175 (0.00%)  0 1/180 (0.56%)  1 0/89 (0.00%)  0 0/90 (0.00%)  0
Oesophageal carcinoma  1  1/183 (0.55%)  1 0/175 (0.00%)  0 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Nervous system disorders           
Transient ischaemic attack  1  0/183 (0.00%)  0 0/175 (0.00%)  0 1/180 (0.56%)  1 0/89 (0.00%)  0 0/90 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Abortion spontaneous  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Pre-eclampsia  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury  1  1/183 (0.55%)  1 0/175 (0.00%)  0 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Urinary retention  1  1/183 (0.55%)  2 2/175 (1.14%)  2 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Reproductive system and breast disorders           
Menorrhagia  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Pulmonary embolism  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Surgical and medical procedures           
Hip arthroplasty  1  0/183 (0.00%)  0 0/175 (0.00%)  0 1/180 (0.56%)  1 0/89 (0.00%)  0 0/90 (0.00%)  0
Vascular disorders           
Hypertension  1  0/183 (0.00%)  0 1/175 (0.57%)  1 0/180 (0.00%)  0 0/89 (0.00%)  0 0/90 (0.00%)  0
Hypotension  1  0/183 (0.00%)  0 0/175 (0.00%)  0 1/180 (0.56%)  1 0/89 (0.00%)  0 0/90 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Group 2 Group 3 Group 4 Group 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   172/183 (93.99%)      170/175 (97.14%)      167/180 (92.78%)      70/89 (78.65%)      73/90 (81.11%)    
Gastrointestinal disorders           
Nausea  1  18/183 (9.84%)  18 19/175 (10.86%)  21 13/180 (7.22%)  14 3/89 (3.37%)  3 4/90 (4.44%)  4
General disorders           
Fatigue  1  65/183 (35.52%)  86 67/175 (38.29%)  82 67/180 (37.22%)  94 21/89 (23.60%)  25 21/90 (23.33%)  24
Feverishness  1  28/183 (15.30%)  34 31/175 (17.71%)  35 35/180 (19.44%)  41 1/89 (1.12%)  1 6/90 (6.67%)  7
Injection site pruritus  1  19/183 (10.38%)  22 12/175 (6.86%)  12 14/180 (7.78%)  17 2/89 (2.25%)  2 4/90 (4.44%)  4
Injection site erythema  1  51/183 (27.87%)  61 47/175 (26.86%)  58 58/180 (32.22%)  76 23/89 (25.84%)  30 25/90 (27.78%)  31
Injection site haemorrhage  1  17/183 (9.29%)  18 22/175 (12.57%)  23 18/180 (10.00%)  21 3/89 (3.37%)  3 10/90 (11.11%)  11
Injection site induration  1  46/183 (25.14%)  54 41/175 (23.43%)  52 62/180 (34.44%)  84 11/89 (12.36%)  11 14/90 (15.56%)  15
Injection site pain  1  87/183 (47.54%)  128 99/175 (56.57%)  140 110/180 (61.11%)  170 12/89 (13.48%)  15 15/90 (16.67%)  18
Injection site tenderness  1  142/183 (77.60%)  233 146/175 (83.43%)  230 150/180 (83.33%)  258 28/89 (31.46%)  41 37/90 (41.11%)  46
Malaise  1  45/183 (24.59%)  51 44/175 (25.14%)  53 44/180 (24.44%)  56 5/89 (5.62%)  5 8/90 (8.89%)  8
Infections and infestations           
Upper respiratory tract infection  1  7/183 (3.83%)  7 10/175 (5.71%)  12 14/180 (7.78%)  16 6/89 (6.74%)  7 6/90 (6.67%)  6
Investigations           
Haemoglobin decreased  1  9/183 (4.92%)  18 12/175 (6.86%)  23 5/180 (2.78%)  12 11/89 (12.36%)  23 7/90 (7.78%)  12
Platelet count decreased  1  2/183 (1.09%)  5 5/175 (2.86%)  9 3/180 (1.67%)  3 2/89 (2.25%)  3 5/90 (5.56%)  8
White blood cell count decreased  1  20/183 (10.93%)  29 18/175 (10.29%)  28 24/180 (13.33%)  42 13/89 (14.61%)  18 10/90 (11.11%)  17
White blood cell count increased  1  1/183 (0.55%)  3 9/175 (5.14%)  12 1/180 (0.56%)  2 4/89 (4.49%)  6 0/90 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  28/183 (15.30%)  35 21/175 (12.00%)  23 35/180 (19.44%)  38 7/89 (7.87%)  9 7/90 (7.78%)  7
Myalgia  1  57/183 (31.15%)  74 57/175 (32.57%)  68 57/180 (31.67%)  75 10/89 (11.24%)  13 16/90 (17.78%)  18
Nervous system disorders           
Headache  1  55/183 (30.05%)  66 51/175 (29.14%)  60 52/180 (28.89%)  61 19/89 (21.35%)  21 18/90 (20.00%)  20
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lisa A. Jackson, MD, MPH
Organization: Kaiser Permanente Washington Health Research Institute
Phone: 206-442-5216
EMail: lisa.a.jackson@kp.org
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03312231    
Other Study ID Numbers: 17-0075
HHSN272201400004I
First Submitted: October 12, 2017
First Posted: October 17, 2017
Results First Submitted: September 17, 2020
Results First Posted: October 12, 2020
Last Update Posted: October 12, 2020