Trial Outcomes & Findings for A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly (NCT NCT00953524)
NCT ID: NCT00953524
Last Updated: 2014-03-10
Results Overview
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
849 participants
Primary outcome timeframe
Pre-vaccination (Day 0) and day 21 post-vaccination
Results posted on
2014-03-10
Participant Flow
Participants were enrolled from 06 August 2009 to 07 August 2009 at 15 US clinical centers.
A total of 849 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
Participant milestones
| Measure |
A/H1N1 Vaccine Group 1
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
249
|
254
|
247
|
99
|
|
Overall Study
COMPLETED
|
227
|
239
|
233
|
91
|
|
Overall Study
NOT COMPLETED
|
22
|
15
|
14
|
8
|
Reasons for withdrawal
| Measure |
A/H1N1 Vaccine Group 1
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
2
|
|
Overall Study
Protocol Violation
|
18
|
10
|
11
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
1
|
0
|
Baseline Characteristics
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
Baseline characteristics by cohort
| Measure |
A/H1N1 Vaccine Group 1
n=249 Participants
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=254 Participants
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=247 Participants
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=99 Participants
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
Total
n=849 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
150 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
499 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
99 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
350 Participants
n=21 Participants
|
|
Age, Continuous
|
52.8 Years
STANDARD_DEVIATION 19.2 • n=5 Participants
|
53.4 Years
STANDARD_DEVIATION 18.9 • n=7 Participants
|
54.4 Years
STANDARD_DEVIATION 18.4 • n=5 Participants
|
56.4 Years
STANDARD_DEVIATION 18.1 • n=4 Participants
|
53.4 Years
STANDARD_DEVIATION 18.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
485 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
364 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
249 participants
n=5 Participants
|
254 participants
n=7 Participants
|
247 participants
n=5 Participants
|
99 participants
n=4 Participants
|
849 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination (Day 0) and day 21 post-vaccinationPopulation: Pre- and post-vaccination antibody titers were assessed in the per-protocol population.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Outcome measures
| Measure |
A/H1N1 Vaccine Group 1
n=124 Participants
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=128 Participants
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=132 Participants
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=45 Participants
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Pre-Vaccination 1 (Day 0) Titers at ≥ 10
|
69 Participants
|
70 Participants
|
61 Participants
|
23 Participants
|
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Post-Vaccination 1 (Day 21) Titers at ≥ 10
|
124 Participants
|
127 Participants
|
132 Participants
|
21 Participants
|
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Post-Vaccination 2 (Day 42) Titers at ≥ 10
|
124 Participants
|
128 Participants
|
132 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination (Day 0) and Day 21 post-vaccinationPopulation: Antibody titers were assessed in the per-protocol population.
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Outcome measures
| Measure |
A/H1N1 Vaccine Group 1
n=124 Participants
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=128 Participants
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=132 Participants
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=45 Participants
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Pre-Vaccination 1 (Day 0) Titers at ≥ 40
|
27 Participants
|
37 Participants
|
32 Participants
|
11 Participants
|
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Post-Vaccination 1 (Day 21) Titers at ≥ 40
|
118 Participants
|
126 Participants
|
132 Participants
|
10 Participants
|
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Post-Vaccination 2 (Day 42) Titers at ≥ 40
|
124 Participants
|
127 Participants
|
131 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination (Day 0) and 21 days post-vaccinationPopulation: Antibody titers were assessed in the per-protocol population.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Outcome measures
| Measure |
A/H1N1 Vaccine Group 1
n=124 Participants
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=128 Participants
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=132 Participants
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=45 Participants
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Pre-Vaccination 1 (Day 0) GMT
|
14.5 Titers
Interval 11.6 to 18.1
|
17.3 Titers
Interval 13.5 to 22.1
|
14.1 Titers
Interval 11.0 to 18.0
|
14.0 Titers
Interval 9.31 to 21.2
|
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Post-Vaccination 1 (Day 21) GMT
|
708 Titers
Interval 555.0 to 903.0
|
1362 Titers
Interval 1073.0 to 1729.0
|
1526 Titers
Interval 1229.0 to 1895.0
|
13.1 Titers
Interval 8.89 to 19.3
|
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Post-Vaccination 2 (Day 42) GMT
|
800 Titers
Interval 650.0 to 986.0
|
1329 Titers
Interval 1059.0 to 1669.0
|
1331 Titers
Interval 1082.0 to 1638.0
|
13.5 Titers
Interval 9.23 to 19.8
|
PRIMARY outcome
Timeframe: Pre-vaccination (Day 0) and 21 days post-vaccinationPopulation: Pre- and post-vaccination antibody titers were assessed in the per-protocol population.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Outcome measures
| Measure |
A/H1N1 Vaccine Group 1
n=87 Participants
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=87 Participants
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=85 Participants
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=39 Participants
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
Pre-Vaccination 1 (Day 0) Titers at ≥ 10
|
64 Participants
|
54 Participants
|
60 Participants
|
24 Participants
|
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
Post-Vaccination 1 (Day 21) Titers at ≥ 10
|
87 Participants
|
87 Participants
|
85 Participants
|
23 Participants
|
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
Post-Vaccination 2 (Day 42) Titers at ≥ 10
|
87 Participants
|
87 Participants
|
85 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination (Day 0) and 21 days post-vaccinationPopulation: Pre- and post-vaccination antibody titers were assessed in the per-protocol population.
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Outcome measures
| Measure |
A/H1N1 Vaccine Group 1
n=87 Participants
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=87 Participants
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=85 Participants
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=39 Participants
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Pre-Vaccination 1 (Day 0) Titers at ≥ 40
|
21 Participants
|
21 Participants
|
24 Participants
|
10 Participants
|
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Post-Vaccination 1 (Day 21) Titers at ≥ 40
|
82 Participants
|
80 Participants
|
80 Participants
|
9 Participants
|
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Post-Vaccination 2 (Day 42) Titers at ≥ 40
|
85 Participants
|
83 Participants
|
85 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination (Day 0) and 21 days post-vaccinationPopulation: Antibody titers were assessed in the per-protocol population.
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Outcome measures
| Measure |
A/H1N1 Vaccine Group 1
n=87 Participants
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=87 Participants
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=85 Participants
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=39 Participants
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Pre-Vaccination 1 (Day 0) GMT
|
19.1 Titers
Interval 14.8 to 24.5
|
14.7 Titers
Interval 12.0 to 18.1
|
18.3 Titers
Interval 14.1 to 23.7
|
17.5 Titers
Interval 11.0 to 27.9
|
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Post-Vaccination 1 (Day 21) GMT
|
319 Titers
Interval 229.0 to 443.0
|
423 Titers
Interval 298.0 to 600.0
|
578 Titers
Interval 408.0 to 819.0
|
17.5 Titers
Interval 11.2 to 27.4
|
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Post-Vaccination 2 (Day 42) GMT
|
359 Titers
Interval 268.0 to 481.0
|
416 Titers
Interval 311.0 to 556.0
|
604 Titers
Interval 442.0 to 827.0
|
19.0 Titers
Interval 12.1 to 29.7
|
PRIMARY outcome
Timeframe: Days 0 to 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
Outcome measures
| Measure |
A/H1N1 Vaccine Group 1
n=149 Participants
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=152 Participants
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=149 Participants
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=49 Participants
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Induration - Post Dose 2
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Induration - Any Dose
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Ecchymosis - Post Dose 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Ecchymosis - Post Dose 2
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Ecchymosis - Any Dose
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grade 3 Ecchymosis (> 10 cm) - Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grade 3 Induration (> 10 cm) - Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Solicited Systemic Reaction - Any Dose
|
81 Participants
|
73 Participants
|
78 Participants
|
24 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Grade 3 Solicited Systemic Reaction - Any Dose
|
10 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Fever - Post Dose 1
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Fever - Post Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Fever - Any Dose
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grade 3 Fever (≥ 102.1 F or ≥ 39.0 C) - Any Dose
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Headache - Post Dose 1
|
48 Participants
|
48 Participants
|
40 Participants
|
16 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Headache - Post Dose 2
|
36 Participants
|
21 Participants
|
31 Participants
|
11 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Headache - Any Dose
|
60 Participants
|
55 Participants
|
53 Participants
|
19 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grd 3 Headache (Prevents daily activity), Any Dose
|
5 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Malaise - Post Dose 1
|
34 Participants
|
23 Participants
|
27 Participants
|
9 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Malaise - Post Dose 2
|
22 Participants
|
15 Participants
|
25 Participants
|
6 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Malaise - Any Dose
|
43 Participants
|
31 Participants
|
42 Participants
|
13 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grd 3 Malaise (Prevents daily activity) - Any Dose
|
6 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Myalgia - Post Dose 1
|
43 Participants
|
30 Participants
|
33 Participants
|
11 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Myalgia - Post Dose 2
|
22 Participants
|
16 Participants
|
26 Participants
|
5 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Myalgia - Any Dose
|
49 Participants
|
34 Participants
|
49 Participants
|
13 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grd 3 Myalgia (Prevents daily activity) - Any Dose
|
6 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Shivering - Post Dose 1
|
10 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Shivering - Post Dose 2
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Shivering - Any Dose
|
12 Participants
|
2 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grade 3 Shivering (Prevents activity) - Any Dose
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Induration - Post Dose 1
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Solicited Injection Site Reaction - Any Dose
|
65 Participants
|
60 Participants
|
73 Participants
|
9 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grade 3 Injection Site Reaction - Any Dose
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Pain - Post Dose 1
|
53 Participants
|
43 Participants
|
48 Participants
|
8 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Pain - Post Dose 2
|
39 Participants
|
42 Participants
|
56 Participants
|
4 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Pain - Any Dose
|
64 Participants
|
59 Participants
|
72 Participants
|
9 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grade 3 Pain (Prevents daily activity) - Any Dose
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Erythema - Post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Erythema - Post Dose 2
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Erythema - Any Dose
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grade 3 Erythema (> 10 cm) - Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Swelling - Post Dose 1
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Swelling - Post Dose 2
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Any Swelling - Any Dose
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Grade 3 Swelling (> 10 cm) - Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0 to 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
Outcome measures
| Measure |
A/H1N1 Vaccine Group 1
n=99 Participants
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=102 Participants
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=99 Participants
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=50 Participants
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grade 3 Injection Site Reaction - Any Dose
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Pain - Post Dose 1
|
10 Participants
|
12 Participants
|
16 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Pain - Post Dose 2
|
10 Participants
|
14 Participants
|
16 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Pain - Any Dose
|
18 Participants
|
19 Participants
|
24 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Solicited Injection Site Reaction - Any Dose
|
20 Participants
|
19 Participants
|
27 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Swelling - Post Dose 2
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grade 3 Pain (Prevents daily activity) - Any Dose
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Erythema - Post Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Erythema - Post Dose 2
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Erythema - Any Dose
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grade 3 Erythema (> 10 cm) - Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Swelling - Post Dose 1
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Swelling - Any Dose
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grade 3 Swelling (> 10 cm) - Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Induration - Post Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Induration - Post Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Induration - Any Dose
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grade 3 Induration (> 10 cm) - Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Ecchymosis - Post Dose 1
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Ecchymosis - Post Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Ecchymosis - Any Dose
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grade 3 Ecchymosis (> 10 cm) - Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Fever - Any Dose
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Solicited Systemic Reaction - Any Dose
|
28 Participants
|
22 Participants
|
32 Participants
|
13 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Grade 3 Solicited Systemic Reaction - Any Dose
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Fever - Post Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Fever - Post Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Headache - Post Dose 1
|
11 Participants
|
10 Participants
|
16 Participants
|
6 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Headache - Post Dose 2
|
9 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Headache - Any Dose
|
16 Participants
|
13 Participants
|
21 Participants
|
11 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grd 3 Headache (Prevents daily activity), Any Dose
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Malaise - Post Dose 1
|
4 Participants
|
7 Participants
|
15 Participants
|
4 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Malaise - Post Dose 2
|
11 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Malaise - Any Dose
|
14 Participants
|
9 Participants
|
21 Participants
|
8 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grd 3 Malaise (Prevents daily activity) - Any Dose
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Myalgia - Post Dose 1
|
7 Participants
|
9 Participants
|
11 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Myalgia - Post Dose 2
|
5 Participants
|
10 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Myalgia - Any Dose
|
11 Participants
|
16 Participants
|
17 Participants
|
6 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grd 3 Myalgia (Prevents daily activity) - Any Dose
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Shivering - Post Dose 1
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Shivering - Post Dose 2
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Any Shivering - Any Dose
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Grade 3 Shivering (Prevents activity) - Any Dose
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
A/H1N1 Vaccine Group 1
Serious events: 8 serious events
Other events: 82 other events
Deaths: 0 deaths
A/H1N1 Vaccine Group 2
Serious events: 7 serious events
Other events: 78 other events
Deaths: 0 deaths
A/H1N1 Vaccine Group 3
Serious events: 7 serious events
Other events: 96 other events
Deaths: 0 deaths
Placebo Group
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A/H1N1 Vaccine Group 1
n=248 participants at risk
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=254 participants at risk
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=248 participants at risk
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=99 participants at risk
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.39%
1/254 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.81%
2/248 • Number of events 3 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
1.0%
1/99 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.39%
1/254 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Infections and infestations
Cellulitis
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.39%
1/254 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.39%
1/254 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.39%
1/254 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.39%
1/254 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
1.0%
1/99 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignan
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.39%
1/254 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkins lymphoma
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.39%
1/254 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.40%
1/248 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.40%
1/248 • Number of events 2 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.39%
1/254 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Nervous system disorders
Global amnesia
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Nervous system disorders
Myasthenia gravis
|
0.40%
1/248 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
1.0%
1/99 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/254 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
0.00%
0/248 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
1.0%
1/99 • Number of events 1 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
Other adverse events
| Measure |
A/H1N1 Vaccine Group 1
n=248 participants at risk
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 2
n=254 participants at risk
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
|
A/H1N1 Vaccine Group 3
n=248 participants at risk
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
|
Placebo Group
n=99 participants at risk
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
33.9%
82/242 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
31.3%
78/249 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
39.0%
96/246 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
11.2%
11/98 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Nervous system disorders
Headache
|
31.4%
76/242 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
27.3%
68/249 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
30.1%
74/246 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
30.3%
30/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
General disorders
Malaise
|
23.6%
57/242 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
16.1%
40/249 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
25.6%
63/246 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
21.2%
21/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.8%
60/242 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
20.1%
50/249 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
26.8%
66/246 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
19.2%
19/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
|
General disorders
Shivering
|
6.2%
15/242 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
6.0%
15/249 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
4.5%
11/246 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
5.1%
5/99 • Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER