Trial Outcomes & Findings for Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years (NCT NCT01928472)
NCT ID: NCT01928472
Last Updated: 2019-06-11
Results Overview
Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
402 participants
Primary outcome timeframe
Day 1 and 43
Results posted on
2019-06-11
Participant Flow
Subjects were recruited from 6 centers in United States.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
Low Dose + Adj
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
104
|
98
|
102
|
|
Overall Study
COMPLETED
|
90
|
96
|
91
|
100
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
7
|
2
|
Reasons for withdrawal
| Measure |
Low Dose + Adj
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
4
|
0
|
|
Overall Study
Administrative Reason
|
2
|
1
|
0
|
0
|
|
Overall Study
Unclassified
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years
Baseline characteristics by cohort
| Measure |
Low Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=104 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
TOTAL
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
38.3 year
STANDARD_DEVIATION 13.1 • n=99 Participants
|
40.3 year
STANDARD_DEVIATION 12.5 • n=107 Participants
|
42.6 year
STANDARD_DEVIATION 13.1 • n=206 Participants
|
43.4 year
STANDARD_DEVIATION 12.9 • n=7 Participants
|
41.2 year
STANDARD_DEVIATION 13.0 • n=31 Participants
|
|
Sex: Female, Male
FEMALE
|
60 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
218 Participants
n=31 Participants
|
|
Sex: Female, Male
MALE
|
38 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
184 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day 1 and 43Population: The analysis was done on Full Analysis Set - Subjects who received at least one study vaccination and provided immunogenicity at day 43 (FAS-Day 43).
Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination
Outcome measures
| Measure |
Low Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)
Day 1
|
5 Titers
Interval 4.95 to 5.05
|
5 Titers
Interval 4.95 to 5.05
|
5 Titers
Interval 4.95 to 5.05
|
5.05 Titers
Interval 5.0 to 5.1
|
|
Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)
Day 43
|
12 Titers
Interval 9.75 to 15.0
|
19 Titers
Interval 15.0 to 23.0
|
26 Titers
Interval 21.0 to 32.0
|
5.75 Titers
Interval 4.67 to 7.08
|
PRIMARY outcome
Timeframe: Day 43Population: FAS-Day 43
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.
Outcome measures
| Measure |
Low Dose + Adj
n=94 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=97 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)
|
2.42 Ratio
Interval 1.95 to 3.0
|
3.7 Ratio
Interval 3.02 to 4.55
|
5.2 Ratio
Interval 4.21 to 6.43
|
1.14 Ratio
Interval 0.93 to 1.4
|
PRIMARY outcome
Timeframe: Day 43Population: FAS-Day 43
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination. Seroconversion is defined as postvaccination HI titer\> 40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum 4-fold increase in titer for subjects with baseline titer \>1:10.
Outcome measures
| Measure |
Low Dose + Adj
n=94 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=97 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
|
26 Percentages of subjects
Interval 17.0 to 36.0
|
44 Percentages of subjects
Interval 34.0 to 54.0
|
52 Percentages of subjects
Interval 41.0 to 62.0
|
3 Percentages of subjects
Interval 1.0 to 8.0
|
PRIMARY outcome
Timeframe: Day 1 and 43Population: FAS-Day 43.
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.
Outcome measures
| Measure |
Low Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Day 1
|
0 Percentages of subejcts
Interval 0.0 to 4.0
|
0 Percentages of subejcts
Interval 0.0 to 4.0
|
0 Percentages of subejcts
Interval 0.0 to 4.0
|
0 Percentages of subejcts
Interval 0.0 to 4.0
|
|
Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Day 43
|
26 Percentages of subejcts
Interval 17.0 to 36.0
|
44 Percentages of subejcts
Interval 34.0 to 54.0
|
52 Percentages of subejcts
Interval 41.0 to 62.0
|
3 Percentages of subejcts
Interval 1.0 to 8.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 43Population: Analysis was done on unsolicited safety set - All subjects in the exposed set with unsolicited AE data.
Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Outcome measures
| Measure |
Low Dose + Adj
n=97 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Any AEs
|
29 participants
|
31 participants
|
24 participants
|
24 participants
|
|
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
At least possibly related AEs
|
6 participants
|
11 participants
|
7 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 366.Population: Analysis was done on unsolicited safety set.
The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.
Outcome measures
| Measure |
Low Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
AEs leading to withdrawal
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Medically attended AE
|
33 participants
|
43 participants
|
34 participants
|
30 participants
|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
AESI
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
NOCD
|
1 participants
|
7 participants
|
5 participants
|
3 participants
|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Death
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
SAEs
|
2 participants
|
2 participants
|
3 participants
|
1 participants
|
|
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
At least possibly related SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 7 after each vaccination.Population: Analysis was done on the solicited safety set - All subjects in the exposed set with solicited AE data.
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Outcome measures
| Measure |
Low Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Headache
|
18 participants
|
19 participants
|
17 participants
|
11 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Fatigue
|
13 participants
|
19 participants
|
15 participants
|
15 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Vomiting
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Diarrhea
|
5 participants
|
6 participants
|
4 participants
|
8 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Loss of appetite
|
4 participants
|
10 participants
|
7 participants
|
6 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Malaise
|
8 participants
|
17 participants
|
14 participants
|
9 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Body Temp (≥38°C)
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Prevention of pain and/or fever
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Treatment of pain and (or)fever
|
3 participants
|
7 participants
|
7 participants
|
4 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Loss of appetite
|
4 participants
|
10 participants
|
11 participants
|
4 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Nausea
|
11 participants
|
12 participants
|
8 participants
|
5 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Myalgia
|
10 participants
|
23 participants
|
13 participants
|
11 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Arthralgia
|
4 participants
|
13 participants
|
10 participants
|
8 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Headache
|
23 participants
|
36 participants
|
23 participants
|
20 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Fatigue
|
20 participants
|
32 participants
|
24 participants
|
22 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Vomiting
|
3 participants
|
2 participants
|
2 participants
|
0 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Diarrhea
|
10 participants
|
9 participants
|
6 participants
|
7 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Malaise
|
8 participants
|
25 participants
|
23 participants
|
15 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I,Body Temp (≥38°C)
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Prevention of pain and/or fever
|
3 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Treatment of pain and/or fever
|
4 participants
|
12 participants
|
3 participants
|
3 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Any Local-Vaccination II
|
39 participants
|
58 participants
|
46 participants
|
27 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Pain
|
34 participants
|
53 participants
|
45 participants
|
21 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Ecchymosis
|
1 participants
|
3 participants
|
0 participants
|
4 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Erythema
|
11 participants
|
12 participants
|
6 participants
|
9 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Induration
|
9 participants
|
16 participants
|
4 participants
|
6 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Any Systemic-Vaccination II (N=95,102,97,102)
|
33 participants
|
37 participants
|
33 participants
|
25 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Nausea
|
10 participants
|
9 participants
|
9 participants
|
7 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Myalgia
|
8 participants
|
16 participants
|
14 participants
|
7 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination II, Arthralgia
|
5 participants
|
12 participants
|
12 participants
|
3 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Any local-Vaccination I
|
47 participants
|
77 participants
|
60 participants
|
30 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Pain
|
42 participants
|
74 participants
|
53 participants
|
19 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Ecchymosis
|
2 participants
|
2 participants
|
2 participants
|
5 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Erythema
|
11 participants
|
16 participants
|
13 participants
|
11 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Vaccination I, Induration
|
5 participants
|
6 participants
|
9 participants
|
4 participants
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Any systemic-Vaccination I
|
40 participants
|
56 participants
|
44 participants
|
42 participants
|
SECONDARY outcome
Timeframe: Day 1 and 22Population: FAS-Day 22
Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.
Outcome measures
| Measure |
Low Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)
Day 1
|
5 Titers
Interval 4.95 to 5.05
|
5 Titers
Interval 4.95 to 5.05
|
5 Titers
Interval 4.95 to 5.05
|
5.05 Titers
Interval 5.0 to 5.1
|
|
Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)
Day 22 (N=96,103,97,102)
|
5.07 Titers
Interval 4.95 to 5.2
|
5 Titers
Interval 4.88 to 5.12
|
5 Titers
Interval 4.88 to 5.13
|
5.1 Titers
Interval 4.98 to 5.23
|
SECONDARY outcome
Timeframe: Day 22Population: FAS-Day 22
GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.
Outcome measures
| Measure |
Low Dose + Adj
n=96 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=97 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)
|
1.01 Ratio
Interval 1.0 to 1.03
|
1 Ratio
Interval 0.98 to 1.02
|
1 Ratio
Interval 0.98 to 1.02
|
1.01 Ratio
Interval 0.99 to 1.03
|
SECONDARY outcome
Timeframe: Day 22Population: FAS-Day 22
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination. Seroconversion is defined as postvaccination HI titer\> 40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum 4-fold increase in titer for subjects with baseline titer \>1:10.
Outcome measures
| Measure |
Low Dose + Adj
n=96 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=97 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 1 and 22.Population: FAS-Day 22
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.
Outcome measures
| Measure |
Low Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=103 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=98 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Day 1
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
|
Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Day 22
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
1 Percentages of subjects
Interval 0.025 to 5.0
|
SECONDARY outcome
Timeframe: Day 183 and 366.Population: FAS-Day 183 and FAS-Day 366
The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.
Outcome measures
| Measure |
Low Dose + Adj
n=90 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=101 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=94 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=101 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
Day 183
|
5.17 Titers
Interval 4.84 to 5.52
|
5.43 Titers
Interval 5.1 to 5.78
|
5.99 Titers
Interval 5.61 to 6.39
|
5.16 Titers
Interval 4.84 to 5.49
|
|
Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
Day 366 (N=90,96,91,100)
|
5 Titers
Interval 4.78 to 5.23
|
5.14 Titers
Interval 4.92 to 5.37
|
5.14 Titers
Interval 4.92 to 5.38
|
5.16 Titers
Interval 4.94 to 5.38
|
SECONDARY outcome
Timeframe: Day 183 and 366Population: FAS-Day 183 and FAS-Day 366
GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.
Outcome measures
| Measure |
Low Dose + Adj
n=90 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=101 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=94 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=101 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
Day 183/Day 1
|
1.03 Ratio
Interval 0.97 to 1.1
|
1.09 Ratio
Interval 1.02 to 1.15
|
1.2 Ratio
Interval 1.13 to 1.27
|
1.02 Ratio
Interval 0.96 to 1.08
|
|
Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
Day 366/Day 1
|
1 Ratio
Interval 0.96 to 1.04
|
1.03 Ratio
Interval 0.99 to 1.07
|
1.03 Ratio
Interval 0.99 to 1.07
|
1.02 Ratio
Interval 0.98 to 1.06
|
SECONDARY outcome
Timeframe: Day 183 and 366Population: FAS-Day 183 and FAS-Day 366
Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination. Seroconversion is defined as postvaccination HI titer\>40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum four-fold increase in titer for subjects with baseline titer\>1:10.
Outcome measures
| Measure |
Low Dose + Adj
n=90 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=101 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=94 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=101 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Day 183
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
1 Percentages of subjects
Interval 0.025 to 5.0
|
1 Percentages of subjects
Interval 0.027 to 6.0
|
1 Percentages of subjects
Interval 0.025 to 5.0
|
|
Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Day 366
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
1 Percentages of subjects
Interval 0.026 to 6.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
1 Percentages of subjects
Interval 0.025 to 5.0
|
SECONDARY outcome
Timeframe: Day 183 and 366Population: FAS-Day 183 and FAS-Day 366
Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.
Outcome measures
| Measure |
Low Dose + Adj
n=90 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
|
Medium Dose + Adj
n=101 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=94 Participants
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=101 Participants
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
|---|---|---|---|---|
|
Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Day 183
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
1 Percentages of subjects
Interval 0.025 to 5.0
|
1 Percentages of subjects
Interval 0.027 to 6.0
|
1 Percentages of subjects
Interval 0.025 to 5.0
|
|
Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Day 366
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
1 Percentages of subjects
Interval 0.026 to 6.0
|
0 Percentages of subjects
Interval 0.0 to 4.0
|
1 Percentages of subjects
Interval 0.025 to 5.0
|
Adverse Events
Low Dose + Adj
Serious events: 2 serious events
Other events: 71 other events
Deaths: 0 deaths
Medium Dose + Adj
Serious events: 2 serious events
Other events: 87 other events
Deaths: 0 deaths
High Dose + Adj
Serious events: 3 serious events
Other events: 79 other events
Deaths: 0 deaths
High Dose + No Adj
Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths
TOTAL
Serious events: 8 serious events
Other events: 299 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low Dose + Adj
n=98 participants at risk
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
Medium Dose + Adj
n=103 participants at risk
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=98 participants at risk
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 participants at risk
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
TOTAL
n=401 participants at risk
Total of all reporting groups.
|
|---|---|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.97%
1/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.97%
1/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.97%
1/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
1.0%
1/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.97%
1/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Infections and infestations
INFECTION
|
1.0%
1/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Infections and infestations
OSTEOMYELITIS
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.98%
1/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Injury, poisoning and procedural complications
MULTIPLE FRACTURES
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
1.0%
1/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.0%
1/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.97%
1/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.97%
1/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.97%
1/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.0%
1/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
1.0%
1/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.97%
1/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.00%
0/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.25%
1/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
Other adverse events
| Measure |
Low Dose + Adj
n=98 participants at risk
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
Medium Dose + Adj
n=103 participants at risk
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + Adj
n=98 participants at risk
Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
|
High Dose + No Adj
n=102 participants at risk
Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
|
TOTAL
n=401 participants at risk
Total of all reporting groups.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
14.3%
14/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
13.6%
14/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
9.2%
9/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
11.8%
12/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
12.2%
49/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Gastrointestinal disorders
NAUSEA
|
18.4%
18/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
18.4%
19/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
13.3%
13/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
8.8%
9/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
14.7%
59/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Gastrointestinal disorders
VOMITING
|
5.1%
5/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
3.9%
4/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
3.1%
3/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.98%
1/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
3.2%
13/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
General disorders
FATIGUE
|
26.5%
26/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
35.0%
36/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
32.7%
32/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
29.4%
30/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
30.9%
124/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
General disorders
INJECTION SITE INDURATION
|
1.0%
1/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
5.8%
6/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
2.0%
2/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
0.98%
1/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
2.5%
10/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
General disorders
INJECTION SITE PAIN
|
56.1%
55/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
77.7%
80/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
68.4%
67/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
31.4%
32/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
58.4%
234/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
General disorders
MALAISE
|
15.3%
15/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
31.1%
32/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
29.6%
29/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
19.6%
20/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
23.9%
96/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.1%
5/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
1.9%
2/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
3.1%
3/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
3.9%
4/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
3.5%
14/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
4.1%
4/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
7.8%
8/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
5.1%
5/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
9.8%
10/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
6.7%
27/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
7.1%
7/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
16.5%
17/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
14.3%
14/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
9.8%
10/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
12.0%
48/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.2%
11/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
27.2%
28/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
21.4%
21/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
10.8%
11/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
17.7%
71/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
17.3%
17/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
32.0%
33/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
24.5%
24/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
15.7%
16/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
22.4%
90/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
|
Nervous system disorders
HEADACHE
|
34.7%
34/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
43.7%
45/103 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
31.6%
31/98 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
26.5%
27/102 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
34.2%
137/401 • Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, NOCD, medically attended AEs, AEs leading to withdrawal, AESI and concomitant medications associated with these events are collected from day 1 through day 366.
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment. Of total 402 subjects, 401 subjects received study vaccination and were included in the safety analysis. One subject withdrew consent to participate at visit 1 and did not receive any study vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60