Trial Outcomes & Findings for A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly (NCT NCT00952276)
NCT ID: NCT00952276
Last Updated: 2011-10-03
Results Overview
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
548 participants
Primary outcome timeframe
Day 0 and Day 21 post-vaccination
Results posted on
2011-10-03
Participant Flow
Participants were enrolled from 29 October 2009 to 13 November 2009 at 14 US clinical centers.
A total of 548 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
Participant milestones
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
127
|
115
|
122
|
121
|
63
|
|
Overall Study
COMPLETED
|
126
|
115
|
122
|
120
|
63
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
Baseline characteristics by cohort
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=127 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=115 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=122 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=121 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=63 Participants
Participants who received a dose of placebo (normal saline) on Day 0
|
Total
n=548 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
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
75 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
326 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
222 Participants
n=10 Participants
|
|
Age Continuous
Age Continuous
|
54.0 Years
STANDARD_DEVIATION 18.4 • n=5 Participants
|
53.3 Years
STANDARD_DEVIATION 18.7 • n=7 Participants
|
51.9 Years
STANDARD_DEVIATION 18.0 • n=5 Participants
|
52.7 Years
STANDARD_DEVIATION 19.9 • n=4 Participants
|
54.7 Years
STANDARD_DEVIATION 16.7 • n=21 Participants
|
53.4 Years
STANDARD_DEVIATION 18.34 • n=10 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
323 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
225 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
127 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
548 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 21 post-vaccinationPopulation: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
Outcome measures
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=72 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=67 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=72 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=68 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=38 Participants
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Day 0 (Pre-vaccination)
|
44 Participants
|
41 Participants
|
51 Participants
|
46 Participants
|
22 Participants
|
|
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Day 21 (Post-vaccination)
|
71 Participants
|
67 Participants
|
71 Participants
|
68 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 21 post-vaccinationPopulation: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Outcome measures
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=72 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=67 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=72 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=68 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=38 Participants
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Day 0 (Pre-vaccination)
|
25 Participants
|
24 Participants
|
26 Participants
|
27 Participants
|
11 Participants
|
|
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Day 21 (Post-vaccination)
|
71 Participants
|
66 Participants
|
67 Participants
|
64 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 21 post-vaccinationPopulation: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Outcome measures
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=72 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=67 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=72 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=68 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=38 Participants
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Day 0 (Pre-vaccination)
|
23.7 Titers
Interval 16.2 to 34.6
|
21.0 Titers
Interval 14.4 to 30.5
|
23.8 Titers
Interval 17.1 to 33.1
|
27.7 Titers
Interval 18.4 to 41.7
|
20.0 Titers
Interval 11.2 to 35.7
|
|
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Day 21 (Post-vaccination)
|
896 Titers
Interval 673.0 to 1195.0
|
900 Titers
Interval 653.0 to 1241.0
|
470 Titers
Interval 314.0 to 705.0
|
608 Titers
Interval 423.0 to 875.0
|
26.3 Titers
Interval 15.0 to 46.0
|
PRIMARY outcome
Timeframe: Day 0 and Day 21 post-vaccinationPopulation: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Outcome measures
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=51 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=45 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=47 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=50 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=25 Participants
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Day 0 (Pre-vaccination)
|
35 Participants
|
39 Participants
|
37 Participants
|
38 Participants
|
19 Participants
|
|
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Day 21 (Post-vaccination)
|
50 Participants
|
45 Participants
|
46 Participants
|
50 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 21 post-vaccinationPopulation: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Outcome measures
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=51 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=45 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=47 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=50 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=25 Participants
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Day 0 (Pre-vaccination)
|
23 Participants
|
21 Participants
|
19 Participants
|
20 Participants
|
9 Participants
|
|
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Day 21 (Post-vaccination)
|
48 Participants
|
44 Participants
|
40 Participants
|
40 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 21 post-vaccinationPopulation: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Outcome measures
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=51 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=45 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=47 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=50 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=25 Participants
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Day 0 (Pre-vaccination)
|
28.5 Titers
Interval 18.3 to 44.3
|
40.0 Titers
Interval 25.7 to 62.2
|
26.1 Titers
Interval 18.3 to 37.2
|
23.0 Titers
Interval 16.4 to 32.1
|
25.7 Titers
Interval 14.6 to 45.2
|
|
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Day 21 (Post-vaccination)
|
501 Titers
Interval 330.0 to 761.0
|
630 Titers
Interval 432.0 to 920.0
|
177 Titers
Interval 108.0 to 292.0
|
189 Titers
Interval 118.0 to 301.0
|
26.8 Titers
Interval 14.7 to 48.8
|
PRIMARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent to treat population aged 18 to 64 years.
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Outcome measures
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=75 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=69 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=73 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=71 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=38 Participants
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Grade 3 Headache (Prevents daily activity)
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Any Shivering
|
6 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Grade 3 Shivering (Prevents daily activity)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Any Solicited Injection Site Pain
|
52 Participants
|
53 Participants
|
13 Participants
|
17 Participants
|
11 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Grade 3 Pain (Prevents daily activity)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Any Solicited Injection Site Erythema
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Grade 3 Erythema (> 10 cm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Any Solicited Injection Site Swelling
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Grade 3 Swelling (> 10 cm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Any Solicited Injection Site Induration
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Grade 3 Induration (> 10 cm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Any Solicited Injection Site Ecchymosis
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Grade 3 Ecchymosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Any Fever
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Any Headache
|
36 Participants
|
27 Participants
|
25 Participants
|
24 Participants
|
15 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Any Malaise
|
29 Participants
|
21 Participants
|
20 Participants
|
12 Participants
|
8 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Grade 3 Malaise (Prevents daily activity)
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Any Myalgia
|
36 Participants
|
28 Participants
|
12 Participants
|
17 Participants
|
12 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Grade 3 Myalgia (Prevents daily activity)
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population aged 65 years or older.
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Outcome measures
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=52 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=46 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=49 Participants
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=50 Participants
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=25 Participants
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Any Solicited Injection Site Pain
|
21 Participants
|
22 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Grade 3 Pain (Prevents daily activities)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Any Solicited Injection Site Erythema
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Grade 3 Erythema (> 10 cm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Any Solicited Injection Site Swelling
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Grade 3 Swelling (> 10 cm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Any Solicited Injection Site Induration
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Grade 3 Induration (> 10 cm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Any Solicited Injection Site Ecchymosis
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Grade 3 Ecchymosis (> 10 cm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Any Fever
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Any Headache
|
10 Participants
|
10 Participants
|
5 Participants
|
10 Participants
|
3 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Grade 3 Headache (Prevents daily activity)
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Any Malaise
|
8 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Grade 3 Malaise (Prevents daily activity)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Any Myalgia
|
12 Participants
|
11 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Grade 3 Myalgia (Prevents daily activity)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Any Shivering
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Grade 3 Shivering (Prevents daily activity)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
Serious events: 6 serious events
Other events: 77 other events
Deaths: 0 deaths
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
Serious events: 5 serious events
Other events: 75 other events
Deaths: 0 deaths
Group 3: A/H1N1 Vaccine Formulation 3
Serious events: 5 serious events
Other events: 75 other events
Deaths: 0 deaths
Group 4: A/H1N1 Vaccine Formulation 4
Serious events: 4 serious events
Other events: 82 other events
Deaths: 0 deaths
Group 5: Placebo
Serious events: 5 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=127 participants at risk
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=115 participants at risk
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=122 participants at risk
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=121 participants at risk
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=63 participants at risk
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.87%
1/115 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.83%
1/121 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.87%
1/115 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.87%
1/115 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.87%
1/115 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.79%
1/127 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
1.6%
1/63 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.87%
1/115 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Infections and infestations
Diverticulitis
|
0.79%
1/127 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.87%
1/115 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
1.6%
1/63 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.79%
1/127 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.83%
1/121 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.83%
1/121 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.79%
1/127 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.79%
1/127 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
—
0/0 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
3.2%
2/63 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.79%
1/127 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.83%
1/121 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.82%
1/122 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.87%
1/115 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
1.6%
1/63 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.83%
1/121 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/122 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.83%
1/121 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Vascular disorders
Hypertension
|
0.00%
0/127 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.82%
1/122 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/121 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/63 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
Other adverse events
| Measure |
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant
n=127 participants at risk
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant
n=115 participants at risk
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
|
Group 3: A/H1N1 Vaccine Formulation 3
n=122 participants at risk
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
|
Group 4: A/H1N1 Vaccine Formulation 4
n=121 participants at risk
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
|
Group 5: Placebo
n=63 participants at risk
Participants who received a dose of placebo (normal saline) on Day 0
|
|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
57.5%
73/127 • Number of events 73 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
65.2%
75/115 • Number of events 75 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
12.3%
15/122 • Number of events 15 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
19.8%
24/121 • Number of events 24 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
20.6%
13/63 • Number of events 13 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
General disorders
Malaise
|
29.1%
37/127 • Number of events 37 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
21.7%
25/115 • Number of events 25 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
18.9%
23/122 • Number of events 23 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
14.0%
17/121 • Number of events 17 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
14.3%
9/63 • Number of events 9 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
General disorders
Shivering
|
6.3%
8/127 • Number of events 8 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
8.7%
10/115 • Number of events 10 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
5.7%
7/122 • Number of events 7 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
7.4%
9/121 • Number of events 9 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
6.3%
4/63 • Number of events 4 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Investigations
Haemoglobin decreased
|
60.6%
77/127 • Number of events 90 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
60.9%
70/115 • Number of events 78 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
56.6%
69/122 • Number of events 77 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
66.9%
81/121 • Number of events 91 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
58.7%
37/63 • Number of events 42 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Investigations
Neutrophil count decreased
|
0.79%
1/127 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
0.00%
0/115 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
8.2%
10/122 • Number of events 10 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
5.8%
7/121 • Number of events 7 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
6.3%
4/63 • Number of events 4 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
37.8%
48/127 • Number of events 48 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
33.9%
39/115 • Number of events 39 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
12.4%
15/121 • Number of events 15 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
11.6%
14/121 • Number of events 14 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
22.2%
14/63 • Number of events 14 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Nervous system disorders
Headache
|
5.5%
7/127 • Number of events 10 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
5.2%
6/115 • Number of events 6 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
4.9%
6/122 • Number of events 12 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
2.5%
3/121 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
1.6%
1/63 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.9%
5/127 • Number of events 5 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
5.2%
6/115 • Number of events 8 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
1.6%
2/122 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
5.0%
6/121 • Number of events 7 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
3.2%
2/63 • Number of events 2 • Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
|
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