Trial Outcomes & Findings for Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months (NCT NCT00996307)
NCT ID: NCT00996307
Last Updated: 2017-05-30
Results Overview
CBER guidance (\<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
654 participants
Primary outcome timeframe
21 days after each vaccination
Results posted on
2017-05-30
Participant Flow
Participants were enrolled at 29 sites in USA and Mexico. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
All subjects enrolled were included in the trial. The data entered is for the overall study.
Participant milestones
| Measure |
3.75_(50)MF59
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
164
|
165
|
160
|
165
|
|
Overall Study
COMPLETED
|
144
|
148
|
146
|
144
|
|
Overall Study
NOT COMPLETED
|
20
|
17
|
14
|
21
|
Reasons for withdrawal
| Measure |
3.75_(50)MF59
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
5
|
5
|
|
Overall Study
Lost to Follow-up
|
13
|
13
|
7
|
15
|
|
Overall Study
Administrative reason
|
0
|
1
|
0
|
0
|
|
Overall Study
Unable to classify
|
4
|
0
|
2
|
1
|
Baseline Characteristics
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
Baseline characteristics by cohort
| Measure |
3.75_(50)MF59
n=164 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=165 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=160 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=165 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
Total
n=654 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
6 to <36 Months age
|
21.2 Months
STANDARD_DEVIATION 7.9 • n=99 Participants
|
21.6 Months
STANDARD_DEVIATION 8.8 • n=107 Participants
|
21.1 Months
STANDARD_DEVIATION 8.4 • n=206 Participants
|
21.3 Months
STANDARD_DEVIATION 8.9 • n=7 Participants
|
21.3 Months
STANDARD_DEVIATION 8.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
78 Participants
n=7 Participants
|
312 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
87 Participants
n=7 Participants
|
342 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 21 days after each vaccinationPopulation: The analysis was done on the per-protocol set (PPS).
CBER guidance (\<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Outcome measures
| Measure |
3.75_(50)MF59
n=129 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=124 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=126 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=129 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
3.75_(50)MF59-Previous Vaccination
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59-Previous Vaccination
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50) MF59-Previous Vaccinaiton
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59-Previous Vaccination
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|---|---|---|---|
|
Antibody Responses After the First and Second Vaccinations
HI titer ≥1:40 (Baseline)
|
19 Percentages of Subjects
Interval 12.0 to 26.0
|
9 Percentages of Subjects
Interval 5.0 to 15.0
|
15 Percentages of Subjects
Interval 9.0 to 23.0
|
19 Percentages of Subjects
Interval 13.0 to 27.0
|
—
|
—
|
—
|
—
|
|
Antibody Responses After the First and Second Vaccinations
HI titer ≥1:40 (Day 22)
|
79 Percentages of Subjects
Interval 71.0 to 86.0
|
37 Percentages of Subjects
Interval 29.0 to 46.0
|
86 Percentages of Subjects
Interval 78.0 to 91.0
|
50 Percentages of Subjects
Interval 41.0 to 59.0
|
—
|
—
|
—
|
—
|
|
Antibody Responses After the First and Second Vaccinations
Seroconversion Day 22
|
74 Percentages of Subjects
Interval 65.0 to 81.0
|
32 Percentages of Subjects
Interval 24.0 to 41.0
|
80 Percentages of Subjects
Interval 72.0 to 87.0
|
44 Percentages of Subjects
Interval 35.0 to 53.0
|
—
|
—
|
—
|
—
|
|
Antibody Responses After the First and Second Vaccinations
HI titer ≥1:40 (Day 43)
|
100 Percentages of Subjects
Interval 97.0 to 100.0
|
70 Percentages of Subjects
Interval 61.0 to 78.0
|
100 Percentages of Subjects
Interval 97.0 to 100.0
|
81 Percentages of Subjects
Interval 74.0 to 88.0
|
—
|
—
|
—
|
—
|
|
Antibody Responses After the First and Second Vaccinations
Seroconversion Day 43
|
98 Percentages of Subjects
Interval 93.0 to 100.0
|
68 Percentages of Subjects
Interval 59.0 to 76.0
|
98 Percentages of Subjects
Interval 94.0 to 100.0
|
76 Percentages of Subjects
Interval 68.0 to 83.0
|
—
|
—
|
—
|
—
|
|
Antibody Responses After the First and Second Vaccinations
HI titer ≥1:40 (Day 202;N=45,38,46,38)
|
96 Percentages of Subjects
Interval 85.0 to 99.0
|
50 Percentages of Subjects
Interval 33.0 to 67.0
|
100 Percentages of Subjects
Interval 92.0 to 100.0
|
55 Percentages of Subjects
Interval 38.0 to 71.0
|
—
|
—
|
—
|
—
|
|
Antibody Responses After the First and Second Vaccinations
Seroconversion Day 202;N=45,38,46,38)
|
89 Percentages of Subjects
Interval 76.0 to 96.0
|
50 Percentages of Subjects
Interval 33.0 to 67.0
|
91 Percentages of Subjects
Interval 79.0 to 98.0
|
39 Percentages of Subjects
Interval 24.0 to 57.0
|
—
|
—
|
—
|
—
|
|
Antibody Responses After the First and Second Vaccinations
HI titer ≥1:40 (Day 387;N=46,37,38,36)
|
85 Percentages of Subjects
Interval 71.0 to 94.0
|
27 Percentages of Subjects
Interval 14.0 to 44.0
|
84 Percentages of Subjects
Interval 69.0 to 94.0
|
36 Percentages of Subjects
Interval 21.0 to 54.0
|
—
|
—
|
—
|
—
|
|
Antibody Responses After the First and Second Vaccinations
Seroconversion Day 387;N=45,38,46,38)
|
76 Percentages of Subjects
Interval 61.0 to 87.0
|
22 Percentages of Subjects
Interval 10.0 to 38.0
|
76 Percentages of Subjects
Interval 60.0 to 89.0
|
25 Percentages of Subjects
Interval 12.0 to 42.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to 7Population: The analysis was done on the safety set which included the five subjects who received wrong vaccination according to the randomization. These five subjects were excluded from PPS.
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
Outcome measures
| Measure |
3.75_(50)MF59
n=161 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=161 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=161 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=163 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
3.75_(50)MF59-Previous Vaccination
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59-Previous Vaccination
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50) MF59-Previous Vaccinaiton
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59-Previous Vaccination
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Erythema
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Swelling
|
6 Participants
|
9 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Induration
|
8 Participants
|
8 Participants
|
13 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Tenderness
|
49 Participants
|
42 Participants
|
53 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Sleepiness
|
36 Participants
|
28 Participants
|
38 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Diarrhea
|
32 Participants
|
28 Participants
|
37 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Vomiting
|
13 Participants
|
10 Participants
|
12 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Irritability
|
40 Participants
|
39 Participants
|
45 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Change in eating habits
|
21 Participants
|
16 Participants
|
19 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Persist crying
|
34 Participants
|
35 Participants
|
35 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Fever≥38.5°C
|
5 Participants
|
5 Participants
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Ecchymosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 22 to 28Population: The analysis was done on the safety set. Almost all the subjects across the vaccine groups received their first and second vaccinations within the protocol-specified window. While all the enrolled subjects received their first vaccination, 3% to 7% of subjects across the vaccine groups did not receive their second vaccination.
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
Outcome measures
| Measure |
3.75_(50)MF59
n=155 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=148 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=157 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=157 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
3.75_(50)MF59-Previous Vaccination
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59-Previous Vaccination
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50) MF59-Previous Vaccinaiton
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59-Previous Vaccination
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Ecchymosis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Erythema
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Swelling
|
2 Participants
|
1 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Induration
|
4 Participants
|
3 Participants
|
12 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Tenderness
|
35 Participants
|
27 Participants
|
37 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Sleepiness
|
28 Participants
|
21 Participants
|
20 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Diarrhea
|
20 Participants
|
19 Participants
|
20 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Vomiting
|
11 Participants
|
9 Participants
|
14 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Irritability
|
36 Participants
|
39 Participants
|
32 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Change in eating habits
|
20 Participants
|
18 Participants
|
14 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Persist crying
|
21 Participants
|
22 Participants
|
24 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Fever≥38.5°C
|
8 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days after each vaccinationPopulation: The analysis was done on the Full Analysis Set (FAS).
Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.
Outcome measures
| Measure |
3.75_(50)MF59
n=129 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=124 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=126 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=129 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
3.75_(50)MF59-Previous Vaccination
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59-Previous Vaccination
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50) MF59-Previous Vaccinaiton
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59-Previous Vaccination
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|---|---|---|---|
|
Immunogenicity Measurement by Geometric Mean Titers (GMT)
GMT Baseline
|
10 Titers
Interval 7.94 to 14.0
|
7.27 Titers
Interval 5.5 to 9.6
|
9.29 Titers
Interval 7.06 to 12.0
|
11 Titers
Interval 8.22 to 14.0
|
—
|
—
|
—
|
—
|
|
Immunogenicity Measurement by Geometric Mean Titers (GMT)
GMT Day 22
|
83 Titers
Interval 56.0 to 123.0
|
20 Titers
Interval 14.0 to 31.0
|
92 Titers
Interval 62.0 to 136.0
|
37 Titers
Interval 25.0 to 55.0
|
—
|
—
|
—
|
—
|
|
Immunogenicity Measurement by Geometric Mean Titers (GMT)
GMT Day 43
|
642 Titers
Interval 468.0 to 879.0
|
80 Titers
Interval 58.0 to 110.0
|
626 Titers
Interval 457.0 to 858.0
|
151 Titers
Interval 110.0 to 206.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)Population: The analysis was done on the subgroup of the per-protocol set(PPS).
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Outcome measures
| Measure |
3.75_(50)MF59
n=81 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=83 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=92 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=89 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
3.75_(50)MF59-Previous Vaccination
n=48 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59-Previous Vaccination
n=41 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50) MF59-Previous Vaccinaiton
n=34 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59-Previous Vaccination
n=40 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|---|---|---|---|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Seroconversion (Day 22/Day 1)
|
73 Percentages of Subjects
Interval 62.0 to 82.0
|
37 Percentages of Subjects
Interval 27.0 to 49.0
|
78 Percentages of Subjects
Interval 68.0 to 86.0
|
44 Percentages of Subjects
Interval 33.0 to 55.0
|
75 Percentages of Subjects
Interval 60.0 to 86.0
|
22 Percentages of Subjects
Interval 11.0 to 38.0
|
85 Percentages of Subjects
Interval 69.0 to 95.0
|
45 Percentages of Subjects
Interval 29.0 to 62.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Seroconversion (Day 43/Day 1)
|
99 Percentages of Subjects
Interval 93.0 to 100.0
|
66 Percentages of Subjects
Interval 55.0 to 76.0
|
98 Percentages of Subjects
Interval 92.0 to 100.0
|
78 Percentages of Subjects
Interval 67.0 to 86.0
|
96 Percentages of Subjects
Interval 86.0 to 99.0
|
71 Percentages of Subjects
Interval 54.0 to 84.0
|
100 Percentages of Subjects
Interval 90.0 to 100.0
|
73 Percentages of Subjects
Interval 56.0 to 85.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
HI titer ≥1:40 (Day 1)
|
25 Percentages of Subjects
Interval 16.0 to 36.0
|
12 Percentages of Subjects
Interval 6.0 to 21.0
|
16 Percentages of Subjects
Interval 9.0 to 25.0
|
21 Percentages of Subjects
Interval 13.0 to 31.0
|
8 Percentages of Subjects
Interval 2.0 to 20.0
|
2 Percentages of Subjects
Interval 0.062 to 13.0
|
12 Percentages of Subjects
Interval 3.0 to 27.0
|
15 Percentages of Subjects
Interval 6.0 to 30.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
HI titer ≥1:40 (Day 22)
|
78 Percentages of Subjects
Interval 67.0 to 86.0
|
42 Percentages of Subjects
Interval 31.0 to 54.0
|
84 Percentages of Subjects
Interval 75.0 to 91.0
|
49 Percentages of Subjects
Interval 39.0 to 60.0
|
81 Percentages of Subjects
Interval 67.0 to 91.0
|
27 Percentages of Subjects
Interval 14.0 to 43.0
|
91 Percentages of Subjects
Interval 76.0 to 98.0
|
50 Percentages of Subjects
Interval 34.0 to 66.0
|
|
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
HI titer ≥1:40 (Day 43)
|
100 Percentages of Subjects
Interval 96.0 to 100.0
|
67 Percentages of Subjects
Interval 56.0 to 77.0
|
100 Percentages of Subjects
Interval 96.0 to 100.0
|
83 Percentages of Subjects
Interval 74.0 to 90.0
|
100 Percentages of Subjects
Interval 93.0 to 100.0
|
76 Percentages of Subjects
Interval 60.0 to 88.0
|
100 Percentages of Subjects
Interval 90.0 to 100.0
|
78 Percentages of Subjects
Interval 62.0 to 89.0
|
SECONDARY outcome
Timeframe: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)Population: The analysis was done on the subgroup on the per-protocol set (PPS).
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Outcome measures
| Measure |
3.75_(50)MF59
n=81 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=83 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=92 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=89 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
3.75_(50)MF59-Previous Vaccination
n=48 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59-Previous Vaccination
n=41 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50) MF59-Previous Vaccinaiton
n=34 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59-Previous Vaccination
n=40 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 1
|
11 Titers
Interval 7.66 to 16.0
|
7.95 Titers
Interval 5.58 to 11.0
|
9.94 Titers
Interval 6.93 to 14.0
|
12 Titers
Interval 8.3 to 17.0
|
10 Titers
Interval 6.84 to 15.0
|
6.52 Titers
Interval 4.28 to 9.94
|
8.30 Titers
Interval 5.75 to 13.0
|
10 Titers
Interval 6.58 to 15.0
|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 22
|
101 Titers
Interval 61.0 to 167.0
|
25 Titers
Interval 15.0 to 41.0
|
105 Titers
Interval 63.0 to 173.0
|
42 Titers
Interval 26.0 to 68.0
|
80 Titers
Interval 43.0 to 148.0
|
17 Titers
Interval 8.88 to 34.0
|
100 Titers
Interval 51.0 to 194.0
|
45 Titers
Interval 23.0 to 87.0
|
|
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Day 43
|
975 Titers
Interval 663.0 to 1432.0
|
103 Titers
Interval 71.0 to 149.0
|
788 Titers
Interval 538.0 to 1154.0
|
186 Titers
Interval 129.0 to 271.0
|
389 Titers
Interval 226.0 to 669.0
|
57 Titers
Interval 32.0 to 103.0
|
483 Titers
Interval 269.0 to 867.0
|
124 Titers
Interval 69.0 to 224.0
|
SECONDARY outcome
Timeframe: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)Population: The analysis was done on the subgroup of the per-protocol set (PPS).
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10
Outcome measures
| Measure |
3.75_(50)MF59
n=90 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=96 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=91 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=90 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
3.75_(50)MF59-Previous Vaccination
n=39 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59-Previous Vaccination
n=28 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50) MF59-Previous Vaccinaiton
n=35 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59-Previous Vaccination
n=39 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|---|---|---|---|
|
Antibody Response Based on Baseline Seropositivity
Seroconversion (Day 22/Day 1)
|
72 Percentages of Subjects
Interval 62.0 to 81.0
|
31 Percentages of Subjects
Interval 22.0 to 42.0
|
82 Percentages of Subjects
Interval 73.0 to 90.0
|
39 Percentages of Subjects
Interval 29.0 to 50.0
|
77 Percentages of Subjects
Interval 61.0 to 89.0
|
36 Percentages of Subjects
Interval 19.0 to 56.0
|
74 Percentages of Subjects
Interval 57.0 to 88.0
|
56 Percentages of Subjects
Interval 40.0 to 72.0
|
|
Antibody Response Based on Baseline Seropositivity
Seroconversion (Day 43/Day 1)
|
100 Percentages of Subjects
Interval 96.0 to 100.0
|
67 Percentages of Subjects
Interval 56.0 to 76.0
|
100 Percentages of Subjects
Interval 96.0 to 100.0
|
77 Percentages of Subjects
Interval 67.0 to 85.0
|
92 Percentages of Subjects
Interval 79.0 to 98.0
|
71 Percentages of Subjects
Interval 51.0 to 87.0
|
94 Percentages of Subjects
Interval 81.0 to 99.0
|
74 Percentages of Subjects
Interval 58.0 to 87.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (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
|
62 Percentages of Subjects
Interval 45.0 to 77.0
|
39 Percentages of Subjects
Interval 22.0 to 59.0
|
54 Percentages of Subjects
Interval 37.0 to 71.0
|
64 Percentages of Subjects
Interval 47.0 to 79.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (Day 22)
|
72 Percentages of Subjects
Interval 62.0 to 81.0
|
31 Percentages of Subjects
Interval 22.0 to 42.0
|
82 Percentages of Subjects
Interval 73.0 to 90.0
|
39 Percentages of Subjects
Interval 29.0 to 50.0
|
95 Percentages of Subjects
Interval 83.0 to 99.0
|
57 Percentages of Subjects
Interval 37.0 to 76.0
|
94 Percentages of Subjects
Interval 81.0 to 99.0
|
74 Percentages of Subjects
Interval 58.0 to 87.0
|
|
Antibody Response Based on Baseline Seropositivity
HI titer ≥1:40 (Day 43)
|
100 Percentages of Subjects
Interval 96.0 to 100.0
|
67 Percentages of Subjects
Interval 56.0 to 76.0
|
100 Percentages of Subjects
Interval 96.0 to 100.0
|
77 Percentages of Subjects
Interval 67.0 to 85.0
|
100 Percentages of Subjects
Interval 91.0 to 100.0
|
82 Percentages of Subjects
Interval 63.0 to 94.0
|
100 Percentages of Subjects
Interval 90.0 to 100.0
|
92 Percentages of Subjects
Interval 79.0 to 98.0
|
SECONDARY outcome
Timeframe: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)Population: The analysis was done on the subgroup of the per-protocol set (PPS).
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer \< 1:10).
Outcome measures
| Measure |
3.75_(50)MF59
n=90 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=96 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=91 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=90 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
3.75_(50)MF59-Previous Vaccination
n=39 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59-Previous Vaccination
n=28 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50) MF59-Previous Vaccinaiton
n=35 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59-Previous Vaccination
n=39 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Day 1
|
5.06 Titres
Interval 4.98 to 5.14
|
5.07 Titres
Interval 4.99 to 5.15
|
5.01 Titres
Interval 4.93 to 5.09
|
5.06 Titres
Interval 4.98 to 5.14
|
53 Titres
Interval 34.0 to 83.0
|
35 Titres
Interval 21.0 to 58.0
|
47 Titres
Interval 29.0 to 76.0
|
69 Titres
Interval 44.0 to 108.0
|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Day 22
|
42 Titres
Interval 29.0 to 61.0
|
15 Titres
Interval 11.0 to 22.0
|
60 Titres
Interval 42.0 to 88.0
|
17 Titres
Interval 12.0 to 24.0
|
266 Titres
Interval 137.0 to 517.0
|
67 Titres
Interval 31.0 to 145.0
|
313 Titres
Interval 154.0 to 639.0
|
248 Titres
Interval 126.0 to 487.0
|
|
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Day 43
|
566 Titres
Interval 398.0 to 804.0
|
65 Titres
Interval 46.0 to 93.0
|
577 Titres
Interval 404.0 to 825.0
|
96 Titres
Interval 67.0 to 137.0
|
660 Titres
Interval 390.0 to 1117.0
|
167 Titres
Interval 90.0 to 308.0
|
811 Titres
Interval 462.0 to 1426.0
|
420 Titres
Interval 246.0 to 717.0
|
SECONDARY outcome
Timeframe: 6 months (Day 202) and 12 months (Day 387) after second vaccinationPopulation: The analysis was done on the subgroup of the per-protocol set (PPS).
Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.
Outcome measures
| Measure |
3.75_(50)MF59
n=129 Participants
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=124 Participants
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=126 Participants
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=129 Participants
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
3.75_(50)MF59-Previous Vaccination
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59-Previous Vaccination
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50) MF59-Previous Vaccinaiton
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59-Previous Vaccination
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|---|---|---|---|
|
Antibody Persistence by Geometric Mean Titers (GMT)
GMT (Day 1)
|
10 Titer
Interval 7.94 to 14.0
|
7.27 Titer
Interval 5.5 to 9.6
|
9.29 Titer
Interval 7.06 to 12.0
|
11 Titer
Interval 8.2 to 14.0
|
—
|
—
|
—
|
—
|
|
Antibody Persistence by Geometric Mean Titers (GMT)
GMT (Day 202, N=45, 38, 46, 38)
|
176 Titer
Interval 111.0 to 280.0
|
33 Titer
Interval 20.0 to 54.0
|
205 Titer
Interval 133.0 to 316.0
|
42 Titer
Interval 25.0 to 69.0
|
—
|
—
|
—
|
—
|
|
Antibody Persistence by Geometric Mean Titers (GMT)
GMT (Day 387, N= 46, 37, 38, 36)
|
92 Titer
Interval 52.0 to 162.0
|
15 Titer
Interval 8.24 to 28.0
|
85 Titer
Interval 48.0 to 151.0
|
25 Titer
Interval 13.0 to 46.0
|
—
|
—
|
—
|
—
|
Adverse Events
3.75_(50)MF59
Serious events: 5 serious events
Other events: 144 other events
Deaths: 0 deaths
7.5_(0)MF59
Serious events: 6 serious events
Other events: 152 other events
Deaths: 0 deaths
7.5_(50)MF59
Serious events: 1 serious events
Other events: 141 other events
Deaths: 0 deaths
15_(0)MF59
Serious events: 10 serious events
Other events: 142 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3.75_(50)MF59
n=162 participants at risk
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=164 participants at risk
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=162 participants at risk
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=166 participants at risk
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.61%
1/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.61%
1/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
General disorders
Pyrexia
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.61%
1/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Abdominal abcess
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.61%
1/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Staphylococcal abscess
|
0.62%
1/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.62%
1/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
1.2%
2/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
1.2%
2/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
1.2%
2/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.62%
1/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.60%
1/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.61%
1/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.60%
1/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
1.2%
2/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.60%
1/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.61%
1/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Psychiatric disorders
Mental status changes
|
0.62%
1/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.60%
1/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.60%
1/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.61%
1/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.60%
1/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.62%
1/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Gastroenteritis
|
0.62%
1/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Genital abscess
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.60%
1/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Otitis media
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.61%
1/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
0.00%
0/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
1.8%
3/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
Other adverse events
| Measure |
3.75_(50)MF59
n=162 participants at risk
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(0)MF59
n=164 participants at risk
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
7.5_(50)MF59
n=162 participants at risk
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
15_(0)MF59
n=166 participants at risk
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
9/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
2.4%
4/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
4.3%
7/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
3.0%
5/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Conjunctivitis
|
16.7%
27/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
13.4%
22/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
11.1%
18/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
13.3%
22/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Gastrointestinal disorders
Diarrhoea
|
35.2%
57/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
31.7%
52/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
38.9%
63/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
27.1%
45/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Gastrointestinal disorders
vomiting
|
20.4%
33/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
22.6%
37/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
20.4%
33/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
14.5%
24/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Psychiatric disorders
Irritability
|
35.8%
58/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
37.8%
62/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
37.0%
60/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
31.3%
52/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
General disorders
Pyrexia
|
32.7%
53/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
31.7%
52/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
33.3%
54/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
31.9%
53/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Bronchiolitis
|
6.2%
10/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.3%
12/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
5.6%
9/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.8%
13/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Bronchitis
|
3.1%
5/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
3.7%
6/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
5.6%
9/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
4.2%
7/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Croup infections
|
6.8%
11/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.3%
12/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
4.3%
7/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.2%
12/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Ear infection
|
3.1%
5/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
6.1%
10/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
3.7%
6/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
4.8%
8/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Gastroenteritis
|
7.4%
12/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
5.5%
9/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
2.5%
4/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
4.8%
8/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Nasopharyngitis
|
14.2%
23/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
12.2%
20/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
8.0%
13/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
12.0%
20/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Otitis media
|
34.6%
56/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
23.2%
38/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
22.8%
37/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
27.1%
45/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Otitis media acute
|
8.6%
14/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
6.1%
10/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.4%
12/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.2%
12/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Pharyngitis
|
11.1%
18/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
9.8%
16/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.4%
12/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
10.2%
17/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Pharyngitis streptococcal
|
4.3%
7/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
4.3%
7/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
6.2%
10/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
3.0%
5/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Rhinitis
|
8.6%
14/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
6.7%
11/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
8.0%
13/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.8%
13/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Sinusitis
|
6.8%
11/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
9.8%
16/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
4.9%
8/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.8%
13/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Upper respiratory tract infection
|
38.3%
62/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
32.9%
54/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
31.5%
51/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
38.6%
64/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Infections and infestations
Viral infection
|
11.1%
18/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
8.5%
14/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.4%
12/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
10.2%
17/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
General disorders
Crying
|
29.0%
47/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
28.0%
46/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
29.6%
48/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
25.3%
42/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Nervous system disorders
Somnolence
|
31.5%
51/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
25.0%
41/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
29.6%
48/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
23.5%
39/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Psychiatric disorders
Eating disorder
|
20.4%
33/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
18.3%
30/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
18.5%
30/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
13.9%
23/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
3.7%
6/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
5.5%
9/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
6.2%
10/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
4.2%
7/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.8%
45/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
32.9%
54/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
28.4%
46/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
32.5%
54/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.8%
11/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
6.7%
11/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
8.6%
14/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
6.6%
11/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.9%
8/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
6.1%
10/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
3.1%
5/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
1.8%
3/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.0%
26/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
14.6%
24/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
16.7%
27/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
19.3%
32/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
6.2%
10/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
7.3%
12/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
4.9%
8/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
2.4%
4/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.3%
7/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
4.9%
8/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
3.1%
5/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
5.4%
9/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
|
Nervous system disorders
Injection site pain
|
37.0%
60/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
31.1%
51/164 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
37.0%
60/162 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
30.1%
50/166 • Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second vaccination).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place