Trial Outcomes & Findings for H5N1 Priming and Boosting Strategies (NCT NCT00703053)
NCT ID: NCT00703053
Last Updated: 2013-08-23
Results Overview
The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
505 participants
Primary outcome timeframe
28 days post last vaccination.
Results posted on
2013-08-23
Participant Flow
Healthy ambulatory adults were recruited from the surrounding communities of the research clinics from September 8, 2008 to November 12, 2008.
Participant milestones
| Measure |
VN/VN, Day 0, 7
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
51
|
49
|
51
|
49
|
52
|
97
|
103
|
|
Overall Study
COMPLETED
|
26
|
24
|
48
|
46
|
50
|
43
|
45
|
91
|
102
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
3
|
1
|
6
|
7
|
6
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
H5N1 Priming and Boosting Strategies
Baseline characteristics by cohort
| Measure |
VN/VN, Day 0, 7
n=27 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=51 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=49 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=51 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=49 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=52 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=97 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=103 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
Total
n=505 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
51 Participants
n=36 Participants
|
49 Participants
n=10 Participants
|
52 Participants
n=115 Participants
|
97 Participants
n=40 Participants
|
103 Participants
n=8 Participants
|
505 Participants
n=62 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Age Continuous
|
34.6 years
STANDARD_DEVIATION 9.6 • n=93 Participants
|
34.0 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
37.0 years
STANDARD_DEVIATION 9.2 • n=27 Participants
|
33.6 years
STANDARD_DEVIATION 7.9 • n=483 Participants
|
31.9 years
STANDARD_DEVIATION 8.8 • n=36 Participants
|
33.8 years
STANDARD_DEVIATION 9.3 • n=10 Participants
|
33.5 years
STANDARD_DEVIATION 9.6 • n=115 Participants
|
34.3 years
STANDARD_DEVIATION 9.4 • n=40 Participants
|
35.2 years
STANDARD_DEVIATION 8.4 • n=8 Participants
|
34.3 years
STANDARD_DEVIATION 9.0 • n=62 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
26 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
60 Participants
n=40 Participants
|
61 Participants
n=8 Participants
|
296 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
27 Participants
n=36 Participants
|
23 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
37 Participants
n=40 Participants
|
42 Participants
n=8 Participants
|
209 Participants
n=62 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=93 Participants
|
26 participants
n=4 Participants
|
51 participants
n=27 Participants
|
49 participants
n=483 Participants
|
51 participants
n=36 Participants
|
49 participants
n=10 Participants
|
52 participants
n=115 Participants
|
97 participants
n=40 Participants
|
103 participants
n=8 Participants
|
505 participants
n=62 Participants
|
PRIMARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen
|
14.7 Titer
Interval 7.6 to 28.5
|
27.9 Titer
Interval 11.6 to 67.0
|
6.7 Titer
Interval 5.2 to 8.7
|
13.6 Titer
Interval 8.8 to 20.9
|
15.1 Titer
Interval 9.4 to 24.1
|
39.7 Titer
Interval 23.7 to 66.4
|
10.5 Titer
Interval 7.7 to 14.1
|
9.1 Titer
Interval 7.0 to 11.6
|
22.9 Titer
Interval 16.3 to 32.2
|
PRIMARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen
|
5.1 Titer
Interval 4.9 to 5.2
|
5.1 Titer
Interval 4.9 to 5.2
|
27.6 Titer
Interval 16.8 to 45.5
|
10.1 Titer
Interval 7.1 to 14.4
|
24.3 Titer
Interval 15.1 to 39.2
|
41.3 Titer
Interval 22.9 to 74.7
|
58.7 Titer
Interval 38.0 to 90.7
|
5.3 Titer
Interval 4.8 to 5.9
|
5.7 Titer
Interval 5.2 to 6.3
|
PRIMARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is \<10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Vietnam/04 Antigen
|
8 Participants
|
10 Participants
|
3 Participants
|
11 Participants
|
14 Participants
|
25 Participants
|
8 Participants
|
14 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is \<10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Achieving a 4-fold or Greater HAI Antibody Titer Increase Against A/Indonesia/05 Antigen
|
0 Participants
|
0 Participants
|
23 Participants
|
9 Participants
|
22 Participants
|
24 Participants
|
32 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen
|
8 Participants
|
10 Participants
|
3 Participants
|
11 Participants
|
14 Participants
|
25 Participants
|
8 Participants
|
14 Participants
|
41 Participants
|
PRIMARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The number of subjects who achieve a HAI antibody titer of 1:40 or greater as assessed by the HAI assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Achieving a HAI Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen
|
0 Participants
|
0 Participants
|
23 Participants
|
9 Participants
|
22 Participants
|
24 Participants
|
32 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Duration of studyPopulation: All subjects receiving at least one study vaccination are included in the safety population and analyses of safety are intention to treat (ITT). Three subjects were randomized but not vaccinated.
Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 180 days after the last vaccination.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=25 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=51 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=51 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=49 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=52 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=97 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=103 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Serious Adverse Events
|
0 Events
|
1 Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: 7 days after first vaccinationPopulation: All subjects receiving the first vaccination are included in the safety population and analyses of safety are ITT. Three subjects were randomized but not vaccinated.
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=25 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=51 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=51 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=49 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=52 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=97 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=103 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Fever
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
9 Participants
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Malaise
|
2 Participants
|
4 Participants
|
10 Participants
|
13 Participants
|
16 Participants
|
9 Participants
|
11 Participants
|
25 Participants
|
28 Participants
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Myalgia
|
5 Participants
|
8 Participants
|
13 Participants
|
12 Participants
|
13 Participants
|
9 Participants
|
12 Participants
|
23 Participants
|
25 Participants
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Headache
|
5 Participants
|
11 Participants
|
19 Participants
|
18 Participants
|
20 Participants
|
15 Participants
|
14 Participants
|
32 Participants
|
40 Participants
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Nausea
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
11 Participants
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Pain
|
9 Participants
|
11 Participants
|
10 Participants
|
14 Participants
|
20 Participants
|
28 Participants
|
15 Participants
|
38 Participants
|
44 Participants
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Tenderness
|
17 Participants
|
15 Participants
|
21 Participants
|
35 Participants
|
27 Participants
|
30 Participants
|
20 Participants
|
66 Participants
|
76 Participants
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Redness (functional)
|
3 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
15 Participants
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Redness (measured)
|
3 Participants
|
6 Participants
|
12 Participants
|
9 Participants
|
16 Participants
|
10 Participants
|
8 Participants
|
13 Participants
|
19 Participants
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Swelling (functional)
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of First Vaccination
Swelling (measured)
|
1 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 7 days after second vaccinationPopulation: All subjects receiving the second vaccination are included in this outcome measure. The VN, Day 0 Group received only one dose.
Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after the second vaccination and review the Memory Aid with clinic staff at a follow up visit on Day 8. Subjects are counted if they indicated experiencing the symptom at any severity during the reporting period. The symptoms of redness and swelling were solicited as both functional grading as impact on daily activies as well as collected as a measured value in mm. The number reported for all symptoms is the number reporting greater than none.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=44 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=47 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=97 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Pain
|
9 Participants
|
8 Participants
|
12 Participants
|
7 Participants
|
19 Participants
|
10 Participants
|
11 Participants
|
49 Participants
|
—
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Fever
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
—
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Malaise
|
3 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
13 Participants
|
6 Participants
|
9 Participants
|
24 Participants
|
—
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Myalgia
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
12 Participants
|
5 Participants
|
5 Participants
|
22 Participants
|
—
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Headache
|
7 Participants
|
8 Participants
|
8 Participants
|
11 Participants
|
12 Participants
|
10 Participants
|
13 Participants
|
22 Participants
|
—
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Nausea
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
—
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Tenderness
|
15 Participants
|
14 Participants
|
21 Participants
|
24 Participants
|
28 Participants
|
26 Participants
|
22 Participants
|
71 Participants
|
—
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Redness (functional)
|
4 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
11 Participants
|
—
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Redness (measured)
|
7 Participants
|
4 Participants
|
11 Participants
|
5 Participants
|
7 Participants
|
10 Participants
|
8 Participants
|
22 Participants
|
—
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Swelling (functional)
|
1 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
9 Participants
|
—
|
|
Number of Subjects Reporting Solicited Symptoms Within 7 Days of Second Vaccination
Swelling (measured)
|
3 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen
|
9.1 Titer
Interval 6.6 to 12.6
|
12.6 Titer
Interval 7.5 to 21.2
|
5.8 Titer
Interval 5.1 to 6.5
|
9.8 Titer
Interval 7.5 to 12.6
|
9.6 Titer
Interval 7.7 to 11.9
|
56.6 Titer
Interval 37.2 to 86.0
|
10.9 Titer
Interval 8.6 to 13.9
|
7.1 Titer
Interval 6.1 to 8.3
|
17.0 Titer
Interval 13.7 to 21.0
|
SECONDARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 1 month following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen
|
5.3 Titer
Interval 5.0 to 5.7
|
6.1 Titer
Interval 5.4 to 6.9
|
70.0 Titer
Interval 49.0 to 100.0
|
21.5 Titer
Interval 15.7 to 29.4
|
66.8 Titer
Interval 46.2 to 96.5
|
85.3 Titer
Interval 54.4 to 133.8
|
183.2 Titer
Interval 127.1 to 264.2
|
5.4 Titer
Interval 5.1 to 5.7
|
7.2 Titer
Interval 6.5 to 7.9
|
SECONDARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is \<10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Vietnam/04 Antigen
|
3 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
28 Participants
|
6 Participants
|
7 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The number of subjects who achieve a 4-fold or greater rise in titer, relative to the baseline (Day 0) titer, assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. Subjects whose baseline titer is \<10 must have a post vaccination titer of at least 1:40 to be considered a 4-fold rise.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Achieving a 4-fold or Greater Neutralizing Antibody Titer Increase Against A/Indonesia/05 Antigen
|
0 Participants
|
0 Participants
|
34 Participants
|
14 Participants
|
34 Participants
|
30 Participants
|
43 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Vietnam/04 Antigen
|
3 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
28 Participants
|
6 Participants
|
7 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 28 days post last vaccination.Population: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The number of subjects who achieve a titer of 1:40 or greater as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 28 days following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=45 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=48 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=43 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=46 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=94 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Achieving Neutralizing Antibody Titer of 1:40 or Greater Against A/Indonesia/05 Antigen
|
0 Participants
|
0 Participants
|
34 Participants
|
14 Participants
|
34 Participants
|
30 Participants
|
43 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Six months post last vaccinationPopulation: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The GMTs are as assessed by the HAI assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=25 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=23 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=44 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=41 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=47 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=42 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=44 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=91 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination
|
8.8 Titer
Interval 5.3 to 14.6
|
9.0 Titer
Interval 5.1 to 15.9
|
6.1 Titer
Interval 4.9 to 7.8
|
6.6 Titer
Interval 5.2 to 8.2
|
7.7 Titer
Interval 5.5 to 10.7
|
8.3 Titer
Interval 5.9 to 11.6
|
5.5 Titer
Interval 4.7 to 6.4
|
7.3 Titer
Interval 5.8 to 9.0
|
10.4 Titer
Interval 8.2 to 13.1
|
SECONDARY outcome
Timeframe: Six months after last vaccinationPopulation: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The GMTs are as assessed by the HAI assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations. The CI shown as 5.0 to 5.0 reflect that all subjects had a titer of 5.0 for the VN,VN, Day 0,14 and VN, Day 0 groups.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=25 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=23 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=44 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=41 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=47 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=42 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=44 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=91 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination
|
5.4 Titer
Interval 4.6 to 6.5
|
5.0 Titer
Interval 5.0 to 5.0
|
7.8 Titer
Interval 5.7 to 10.6
|
6.4 Titer
Interval 5.1 to 8.0
|
6.2 Titer
Interval 5.2 to 7.4
|
6.7 Titer
Interval 5.2 to 8.6
|
8.4 Titer
Interval 6.2 to 11.4
|
5.0 Titer
Interval 5.0 to 5.0
|
5.2 Titer
Interval 5.0 to 5.4
|
SECONDARY outcome
Timeframe: Six months post last vaccinationPopulation: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The GMTs are as assessed by the microneutralization assay against the A/Vietnam/04 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=25 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=23 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=44 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=41 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=47 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=42 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=44 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=91 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Neutralizing Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 6 Months Post Last Vaccination
|
5.8 Titer
Interval 4.6 to 7.4
|
8.3 Titer
Interval 5.7 to 12.3
|
5.3 Titer
Interval 4.9 to 5.7
|
6.2 Titer
Interval 5.3 to 7.4
|
6.4 Titer
Interval 5.6 to 7.4
|
7.7 Titer
Interval 6.3 to 9.3
|
5.2 Titer
Interval 4.9 to 5.4
|
5.8 Titer
Interval 5.3 to 6.3
|
8.5 Titer
Interval 7.4 to 9.8
|
SECONDARY outcome
Timeframe: Six months post last vaccinationPopulation: Analyses are based on a modified intent to treat population. 1 subject is excluded at all timepoints due to steroid receipt. 21 subjects not receiving vaccination 2 and one misdosed at vaccination 2 were dropped at timepoints post vaccination 2 only, as were 5 due to receipt of prohibited vaccines/steroids.
The GMTs are as assessed by the microneutralization assay against the A/Indonesia/05 antigen at 6 months following the last vaccination. One group (VN, Day 0) receives only one vaccination, all other groups receive two vaccinations.
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=25 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=23 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=44 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=41 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=47 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=42 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=44 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=91 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Neutralizing Geometric Mean Titer (GMT) Against A/Indonesia/05 Antigen at 6 Months Post Last Vaccination
|
5.5 Titer
Interval 4.9 to 6.2
|
6.0 Titer
Interval 5.2 to 7.0
|
20.6 Titer
Interval 15.8 to 26.9
|
16.1 Titer
Interval 11.7 to 22.1
|
18.4 Titer
Interval 14.0 to 24.1
|
14.7 Titer
Interval 11.8 to 18.4
|
23.0 Titer
Interval 18.2 to 29.2
|
5.5 Titer
Interval 5.2 to 5.7
|
5.9 Titer
Interval 5.5 to 6.4
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3 and 4 after the second dosePopulation: Analyses are based on a modified intent to treat population. 5 subjects in the VN/VN, Day 0, 28 group not receiving vaccination 2 are excluded, as were 2, also in this group, due to receipt of prohibited vaccines.
The kinetics of the antibody response to vaccination with A/Vietnam/04 is evaluated by the HAI GMT against the A/Vietnam/04 antigen at weekly intervals after receipt of 2 doses 7, 14 and 28 days apart
Outcome measures
| Measure |
VN/VN, Day 0, 7
n=26 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=24 Participants
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=95 Participants
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 1, 2, 3 and 4 Weeks After 2 Doses
Week 1
|
16.2 Titer
Interval 8.0 to 32.8
|
33.2 Titer
Interval 14.2 to 77.6
|
23.5 Titer
Interval 16.6 to 33.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 1, 2, 3 and 4 Weeks After 2 Doses
Week 2
|
18.5 Titer
Interval 8.8 to 38.8
|
32.4 Titer
Interval 12.7 to 82.4
|
29.9 Titer
Interval 20.7 to 43.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 1, 2, 3 and 4 Weeks After 2 Doses
Week 3
|
16.2 Titer
Interval 7.8 to 33.3
|
28.7 Titer
Interval 11.9 to 69.4
|
30.9 Titer
Interval 22.1 to 43.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) Against A/Vietnam/04 Antigen at 1, 2, 3 and 4 Weeks After 2 Doses
Week 4
|
14.7 Titer
Interval 7.6 to 28.5
|
27.9 Titer
Interval 11.6 to 67.0
|
22.9 Titer
Interval 16.3 to 32.2
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
VN/VN, Day 0, 7
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
VN/VN, Day 0, 14
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
I/I, Day 0, 28
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
VN/I, Day 0, 28
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
VN+I/VN+I, Day 0, 28
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
VN/I, Day 0, 180
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
I/I, Day 0, 180
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
VN, Day 0
Serious events: 0 serious events
Other events: 85 other events
Deaths: 0 deaths
VN/VN, Day 0, 28
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VN/VN, Day 0, 7
n=26 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=25 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=51 participants at risk
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=48 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=51 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=49 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=52 participants at risk
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=97 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=103 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/26 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
4.0%
1/25 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/51 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/48 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/51 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/49 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/52 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/97 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/103 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Drowning
|
0.00%
0/26 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/25 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/51 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/48 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/51 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/49 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
1.9%
1/52 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/97 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/103 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
Other adverse events
| Measure |
VN/VN, Day 0, 7
n=26 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 7, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 14
n=25 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 14, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
I/I, Day 0, 28
n=51 participants at risk
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN/I, Day 0, 28
n=48 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN+I/VN+I, Day 0, 28
n=51 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 45 mcg dosage and Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 45 mcg dosage.
|
VN/I, Day 0, 180
n=49 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
I/I, Day 0, 180
n=52 participants at risk
Day 0, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage; Day 180, Inactivated subvirion influenza rg A/Indonesia/05/05 (clade 2) x PR8 A/H5N1 vaccine (I); 90 mcg dosage.
|
VN, Day 0
n=97 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
VN/VN, Day 0, 28
n=103 participants at risk
Day 0, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage; Day 28, Inactivated subvirion influenza rg A/Vietnam/1203/04 (clade 1) x PR8 A/H5N1 vaccine (VN); 90 mcg dosage.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/26 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
8.0%
2/25 • Number of events 2 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/51 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/48 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
2.0%
1/51 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
4.1%
2/49 • Number of events 2 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
1.9%
1/52 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/97 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/103 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.7%
2/26 • Number of events 2 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/25 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
2.0%
1/51 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/48 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/51 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
2.0%
1/49 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
1.9%
1/52 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/97 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.97%
1/103 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Nervous system disorders
Headache
|
34.6%
9/26 • Number of events 12 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
52.0%
13/25 • Number of events 19 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
41.2%
21/51 • Number of events 27 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
47.9%
23/48 • Number of events 29 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
47.1%
24/51 • Number of events 32 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
40.8%
20/49 • Number of events 25 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
36.5%
19/52 • Number of events 27 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
33.0%
32/97 • Number of events 32 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
46.6%
48/103 • Number of events 62 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
1/26 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/25 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
5.9%
3/51 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
2.1%
1/48 • Number of events 2 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
3.9%
2/51 • Number of events 2 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
2.0%
1/49 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
1.9%
1/52 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
3.1%
3/97 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
2.9%
3/103 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.7%
2/26 • Number of events 2 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/25 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/51 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/48 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/51 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
2.0%
1/49 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
5.8%
3/52 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/97 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
2.9%
3/103 • Number of events 4 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Reactogenicity event
|
3.8%
1/26 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/25 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
0.00%
0/51 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
4.2%
2/48 • Number of events 2 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
5.9%
3/51 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
2.0%
1/49 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
5.8%
3/52 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
1.0%
1/97 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
2.9%
3/103 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
8.0%
2/25 • Number of events 2 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
15.7%
8/51 • Number of events 8 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
14.6%
7/48 • Number of events 9 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
13.7%
7/51 • Number of events 7 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
12.2%
6/49 • Number of events 6 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
5.8%
3/52 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
9.3%
9/97 • Number of events 9 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
25.2%
26/103 • Number of events 26 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Pyrexia
|
3.8%
1/26 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
12.0%
3/25 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
9.8%
5/51 • Number of events 5 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
6.2%
3/48 • Number of events 4 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
15.7%
8/51 • Number of events 9 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
8.2%
4/49 • Number of events 4 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
11.5%
6/52 • Number of events 6 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
5.2%
5/97 • Number of events 5 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
11.7%
12/103 • Number of events 15 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Malaise
|
15.4%
4/26 • Number of events 5 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
20.0%
5/25 • Number of events 8 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
31.4%
16/51 • Number of events 18 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
29.2%
14/48 • Number of events 17 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
37.3%
19/51 • Number of events 29 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
24.5%
12/49 • Number of events 15 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
28.8%
15/52 • Number of events 20 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
25.8%
25/97 • Number of events 25 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
37.9%
39/103 • Number of events 52 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.8%
8/26 • Number of events 10 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
36.0%
9/25 • Number of events 12 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
33.3%
17/51 • Number of events 18 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
29.2%
14/48 • Number of events 17 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
35.3%
18/51 • Number of events 25 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
22.4%
11/49 • Number of events 14 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
30.8%
16/52 • Number of events 17 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
23.7%
23/97 • Number of events 23 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
35.0%
36/103 • Number of events 47 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
Gastrointestinal disorders
Nausea
|
23.1%
6/26 • Number of events 6 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
8.0%
2/25 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
9.8%
5/51 • Number of events 5 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
14.6%
7/48 • Number of events 7 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
13.7%
7/51 • Number of events 7 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
8.2%
4/49 • Number of events 4 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
13.5%
7/52 • Number of events 8 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
9.3%
9/97 • Number of events 9 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
19.4%
20/103 • Number of events 22 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Injection site pain
|
42.3%
11/26 • Number of events 18 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
52.0%
13/25 • Number of events 19 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
33.3%
17/51 • Number of events 22 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
37.5%
18/48 • Number of events 21 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
45.1%
23/51 • Number of events 39 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
63.3%
31/49 • Number of events 38 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
38.5%
20/52 • Number of events 26 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
39.2%
38/97 • Number of events 38 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
63.1%
65/103 • Number of events 93 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Tenderness
|
69.2%
18/26 • Number of events 32 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
72.0%
18/25 • Number of events 29 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
56.9%
29/51 • Number of events 42 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
77.1%
37/48 • Number of events 59 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
66.7%
34/51 • Number of events 55 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
73.5%
36/49 • Number of events 56 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
55.8%
29/52 • Number of events 42 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
68.0%
66/97 • Number of events 66 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
87.4%
90/103 • Number of events 147 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Injection site erythema (functional grading)
|
19.2%
5/26 • Number of events 7 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
28.0%
7/25 • Number of events 8 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
21.6%
11/51 • Number of events 13 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
14.6%
7/48 • Number of events 10 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
21.6%
11/51 • Number of events 13 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
20.4%
10/49 • Number of events 14 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
21.2%
11/52 • Number of events 13 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
7.2%
7/97 • Number of events 7 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
17.5%
18/103 • Number of events 26 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Injection site erythema (measured values)
|
30.8%
8/26 • Number of events 10 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
32.0%
8/25 • Number of events 10 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
39.2%
20/51 • Number of events 23 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
22.9%
11/48 • Number of events 14 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
37.3%
19/51 • Number of events 23 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
28.6%
14/49 • Number of events 20 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
23.1%
12/52 • Number of events 16 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
13.4%
13/97 • Number of events 13 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
27.2%
28/103 • Number of events 41 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Injection site swelling (functional grading)
|
3.8%
1/26 • Number of events 1 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
16.0%
4/25 • Number of events 5 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
11.8%
6/51 • Number of events 8 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
6.2%
3/48 • Number of events 3 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
13.7%
7/51 • Number of events 7 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
16.3%
8/49 • Number of events 10 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
5.8%
3/52 • Number of events 4 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
5.2%
5/97 • Number of events 5 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
14.6%
15/103 • Number of events 20 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
|
General disorders
Injection site swelling (measured values)
|
15.4%
4/26 • Number of events 4 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
20.0%
5/25 • Number of events 7 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
15.7%
8/51 • Number of events 10 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
8.3%
4/48 • Number of events 4 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
17.6%
9/51 • Number of events 10 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
18.4%
9/49 • Number of events 11 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
7.7%
4/52 • Number of events 6 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
6.2%
6/97 • Number of events 6 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
19.4%
20/103 • Number of events 25 • Solicited symptoms were collected for 7 days after each vaccination, unsolicited non-serious adverse events were collected through 28 days after each vaccination. Serious adverse events were collected through 180 days after the last vaccination.
For the solicited symptoms, subjects are counted if reporting the symptom after either vaccination, with the occurrence within 0-7 days of a vaccination considered 1 event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60