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A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

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ClinicalTrials.gov Identifier: NCT00952276
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : October 3, 2011
Last Update Posted : October 3, 2011
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Influenza
Swine-origin A/H1N1 Influenza
Interventions Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
Biological: Monovalent Subvirion A/H1N1 influenza vaccine
Biological: Normal saline solution
Enrollment 548
Recruitment Details Participants were enrolled from 29 October 2009 to 13 November 2009 at 14 US clinical centers.
Pre-assignment Details A total of 548 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Hide Arm/Group Description Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0 Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0 Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0 Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 Participants who received a dose of placebo (normal saline) on Day 0
Period Title: Overall Study
Started 127 115 122 121 63
Completed 126 115 122 120 63
Not Completed 1 0 0 1 0
Reason Not Completed
Withdrawal by Subject             1             0             0             1             0
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo Total
Hide Arm/Group Description Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0 Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0 Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0 Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 Participants who received a dose of placebo (normal saline) on Day 0 Total of all reporting groups
Overall Number of Baseline Participants 127 115 122 121 63 548
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 115 participants 122 participants 121 participants 63 participants 548 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
75
  59.1%
69
  60.0%
73
  59.8%
71
  58.7%
38
  60.3%
326
  59.5%
>=65 years
52
  40.9%
46
  40.0%
49
  40.2%
50
  41.3%
25
  39.7%
222
  40.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Continuous Number Analyzed 127 participants 115 participants 122 participants 121 participants 63 participants 548 participants
54.0  (18.4) 53.3  (18.7) 51.9  (18.0) 52.7  (19.9) 54.7  (16.7) 53.4  (18.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 115 participants 122 participants 121 participants 63 participants 548 participants
Female
79
  62.2%
65
  56.5%
66
  54.1%
68
  56.2%
45
  71.4%
323
  58.9%
Male
48
  37.8%
50
  43.5%
56
  45.9%
53
  43.8%
18
  28.6%
225
  41.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 127 participants 115 participants 122 participants 121 participants 63 participants 548 participants
127 115 122 121 63 548
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Day 0 and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Participants who received a dose of placebo (normal saline) on Day 0
Overall Number of Participants Analyzed 72 67 72 68 38
Measure Type: Number
Unit of Measure: Participants
Day 0 (Pre-vaccination) 44 41 51 46 22
Day 21 (Post-vaccination) 71 67 71 68 27
2.Primary Outcome
Title 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
Hide Description Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Time Frame Day 0 and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Participants who received a dose of placebo (normal saline) on Day 0
Overall Number of Participants Analyzed 72 67 72 68 38
Measure Type: Number
Unit of Measure: Participants
Day 0 (Pre-vaccination) 25 24 26 27 11
Day 21 (Post-vaccination) 71 66 67 64 13
3.Primary Outcome
Title 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
Hide Description Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Time Frame Day 0 and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Participants who received a dose of placebo (normal saline) on Day 0
Overall Number of Participants Analyzed 72 67 72 68 38
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 0 (Pre-vaccination)
23.7
(16.2 to 34.6)
21.0
(14.4 to 30.5)
23.8
(17.1 to 33.1)
27.7
(18.4 to 41.7)
20.0
(11.2 to 35.7)
Day 21 (Post-vaccination)
896
(673 to 1195)
900
(653 to 1241)
470
(314 to 705)
608
(423 to 875)
26.3
(15.0 to 46.0)
4.Primary Outcome
Title 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
Hide Description Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Time Frame Day 0 and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Participants who received a dose of placebo (normal saline) on Day 0
Overall Number of Participants Analyzed 51 45 47 50 25
Measure Type: Number
Unit of Measure: Participants
Day 0 (Pre-vaccination) 35 39 37 38 19
Day 21 (Post-vaccination) 50 45 46 50 18
5.Primary Outcome
Title 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
Hide Description Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Time Frame Day 0 and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Participants who received a dose of placebo (normal saline) on Day 0
Overall Number of Participants Analyzed 51 45 47 50 25
Measure Type: Number
Unit of Measure: Participants
Day 0 (Pre-vaccination) 23 21 19 20 9
Day 21 (Post-vaccination) 48 44 40 40 9
6.Primary Outcome
Title 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
Hide Description Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Time Frame Day 0 and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Participants who received a dose of placebo (normal saline) on Day 0
Overall Number of Participants Analyzed 51 45 47 50 25
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 0 (Pre-vaccination)
28.5
(18.3 to 44.3)
40.0
(25.7 to 62.2)
26.1
(18.3 to 37.2)
23.0
(16.4 to 32.1)
25.7
(14.6 to 45.2)
Day 21 (Post-vaccination)
501
(330 to 761)
630
(432 to 920)
177
(108 to 292)
189
(118 to 301)
26.8
(14.7 to 48.8)
7.Primary Outcome
Title 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
Hide Description Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent to treat population aged 18 to 64 years.
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Participants who received a dose of placebo (normal saline) on Day 0
Overall Number of Participants Analyzed 75 69 73 71 38
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Pain 52 53 13 17 11
Grade 3 Pain (Prevents daily activity) 1 2 1 0 0
Any Solicited Injection Site Erythema 2 2 2 0 0
Grade 3 Erythema (> 10 cm) 0 0 0 0 0
Any Solicited Injection Site Swelling 3 1 0 0 0
Grade 3 Swelling (> 10 cm) 0 0 0 0 0
Any Solicited Injection Site Induration 1 3 0 0 0
Grade 3 Induration (> 10 cm) 0 0 0 0 0
Any Solicited Injection Site Ecchymosis 4 0 1 0 0
Grade 3 Ecchymosis 0 0 0 0 0
Any Fever 1 0 3 0 0
Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) 0 0 0 0 0
Any Headache 36 27 25 24 15
Grade 3 Headache (Prevents daily activity) 2 3 1 0 0
Any Malaise 29 21 20 12 8
Grade 3 Malaise (Prevents daily activity) 3 3 3 2 0
Any Myalgia 36 28 12 17 12
Grade 3 Myalgia (Prevents daily activity) 3 4 3 2 0
Any Shivering 6 7 6 6 3
Grade 3 Shivering (Prevents daily activity) 1 2 1 0 0
8.Primary Outcome
Title 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
Hide Description Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population aged 65 years or older.
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Participants who received a dose of placebo (normal saline) on Day 0
Overall Number of Participants Analyzed 52 46 49 50 25
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Pain 21 22 2 7 2
Grade 3 Pain (Prevents daily activities) 0 1 0 0 0
Any Solicited Injection Site Erythema 1 1 0 1 0
Grade 3 Erythema (> 10 cm) 0 0 0 0 0
Any Solicited Injection Site Swelling 0 3 0 0 0
Grade 3 Swelling (> 10 cm) 0 0 0 0 0
Any Solicited Injection Site Induration 2 2 0 0 0
Grade 3 Induration (> 10 cm) 0 0 0 0 0
Any Solicited Injection Site Ecchymosis 0 0 0 2 1
Grade 3 Ecchymosis (> 10 cm) 0 0 0 0 0
Any Fever 0 1 0 1 0
Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) 0 0 0 0 0
Any Headache 10 10 5 10 3
Grade 3 Headache (Prevents daily activity) 2 1 0 0 0
Any Malaise 8 4 3 5 1
Grade 3 Malaise (Prevents daily activity) 0 0 0 1 0
Any Myalgia 12 11 3 7 2
Grade 3 Myalgia (Prevents daily activity) 1 1 0 0 0
Any Shivering 2 3 1 3 1
Grade 3 Shivering (Prevents daily activity) 1 0 0 0 0
Time Frame Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Hide Arm/Group Description Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0 Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0 Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0 Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 Participants who received a dose of placebo (normal saline) on Day 0
All-Cause Mortality
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/127 (4.72%)      5/115 (4.35%)      5/122 (4.10%)      4/121 (3.31%)      5/63 (7.94%)    
Cardiac disorders           
Atrial fibrillation * 1  0/127 (0.00%)  0 1/115 (0.87%)  1 0/122 (0.00%)  0 1/121 (0.83%)  1 0/63 (0.00%)  0
Bradycardia * 1  0/127 (0.00%)  0 1/115 (0.87%)  1 0/122 (0.00%)  0 0/121 (0.00%)  0 0/63 (0.00%)  0
Cardiac failure congestive * 1  0/127 (0.00%)  0 1/115 (0.87%)  1 0/122 (0.00%)  0 0/121 (0.00%)  0 0/63 (0.00%)  0
Coronary artery disease * 1  0/127 (0.00%)  0 1/115 (0.87%)  1 0/122 (0.00%)  0 0/121 (0.00%)  0 0/63 (0.00%)  0
Myocardial infarction * 1  1/127 (0.79%)  1 0/115 (0.00%)  0 0/122 (0.00%)  0 0/121 (0.00%)  0 0/63 (0.00%)  0
Sick sinus syndrome * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 0/122 (0.00%)  0 0/121 (0.00%)  0 1/63 (1.59%)  1
Gastrointestinal disorders           
Gastric ulcer * 1  0/127 (0.00%)  0 1/115 (0.87%)  1 0/122 (0.00%)  0 0/121 (0.00%)  0 0/63 (0.00%)  0
Pancreatitis * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 1/122 (0.82%)  1 0/121 (0.00%)  0 0/63 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 1/122 (0.82%)  1 0/121 (0.00%)  0 0/63 (0.00%)  0
Cholelithiasis * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 1/122 (0.82%)  1 0/121 (0.00%)  0 0/63 (0.00%)  0
Infections and infestations           
Diverticulitis * 1  1/127 (0.79%)  1 1/115 (0.87%)  1 0/122 (0.00%)  0 0/121 (0.00%)  0 0/63 (0.00%)  0
Lobar pneumonia * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 0/122 (0.00%)  0 0/121 (0.00%)  0 1/63 (1.59%)  1
Injury, poisoning and procedural complications           
Jaw fracture * 1  1/127 (0.79%)  1 0/115 (0.00%)  0 0/122 (0.00%)  0 0/121 (0.00%)  0 0/63 (0.00%)  0
Metabolism and nutrition disorders           
Diabetes mellitus inadequate control * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 0/122 (0.00%)  0 1/121 (0.83%)  1 0/63 (0.00%)  0
Hypoglycaemia * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 0/122 (0.00%)  0 1/121 (0.83%)  1 0/63 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthritis * 1  1/127 (0.79%)  2 0/115 (0.00%)  0 0/122 (0.00%)  0 0/121 (0.00%)  0 0/63 (0.00%)  0
Intervertebral disc degeneration * 1  1/127 (0.79%)  1 0/115 (0.00%)  0 0/122 (0.00%)  0 0/0  0 0/63 (0.00%)  0
Osteoarthritis * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 0/122 (0.00%)  0 0/121 (0.00%)  0 2/63 (3.17%)  2
Osteonecrosis * 1  1/127 (0.79%)  1 0/115 (0.00%)  0 0/122 (0.00%)  0 0/121 (0.00%)  0 0/63 (0.00%)  0
Rotator cuff syndrome * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 1/122 (0.82%)  1 0/121 (0.00%)  0 0/63 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Lung adenocarcinoma * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 0/122 (0.00%)  0 1/121 (0.83%)  1 0/63 (0.00%)  0
Renal cancer * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 1/122 (0.82%)  2 0/121 (0.00%)  0 0/63 (0.00%)  0
Nervous system disorders           
Nerve compression * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 1/122 (0.82%)  1 0/121 (0.00%)  0 0/63 (0.00%)  0
Renal and urinary disorders           
Calculus ureteric * 1  0/127 (0.00%)  0 1/115 (0.87%)  1 0/122 (0.00%)  0 0/121 (0.00%)  0 0/63 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Bronchial hyperreactivity * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 0/122 (0.00%)  0 0/121 (0.00%)  0 1/63 (1.59%)  1
Chronic obstructive pulmonary disease * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 0/122 (0.00%)  0 1/121 (0.83%)  1 0/63 (0.00%)  0
Pulmonary embolism * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 0/122 (0.00%)  0 1/121 (0.83%)  2 0/63 (0.00%)  0
Vascular disorders           
Hypertension * 1  0/127 (0.00%)  0 0/115 (0.00%)  0 1/122 (0.82%)  1 0/121 (0.00%)  0 0/63 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Group 3: A/H1N1 Vaccine Formulation 3 Group 4: A/H1N1 Vaccine Formulation 4 Group 5: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   77/127 (60.63%)      75/115 (65.22%)      75/122 (61.48%)      82/121 (67.77%)      40/63 (63.49%)    
General disorders           
Injection site pain  1  73/127 (57.48%)  73 75/115 (65.22%)  75 15/122 (12.30%)  15 24/121 (19.83%)  24 13/63 (20.63%)  13
Malaise  1  37/127 (29.13%)  37 25/115 (21.74%)  25 23/122 (18.85%)  23 17/121 (14.05%)  17 9/63 (14.29%)  9
Shivering  1  8/127 (6.30%)  8 10/115 (8.70%)  10 7/122 (5.74%)  7 9/121 (7.44%)  9 4/63 (6.35%)  4
Investigations           
Haemoglobin decreased * 1  77/127 (60.63%)  90 70/115 (60.87%)  78 69/122 (56.56%)  77 81/121 (66.94%)  91 37/63 (58.73%)  42
Neutrophil count decreased * 1  1/127 (0.79%)  1 0/115 (0.00%)  0 10/122 (8.20%)  10 7/121 (5.79%)  7 4/63 (6.35%)  4
Musculoskeletal and connective tissue disorders           
Myalgia  1  48/127 (37.80%)  48 39/115 (33.91%)  39 15/121 (12.40%)  15 14/121 (11.57%)  14 14/63 (22.22%)  14
Nervous system disorders           
Headache  1  46/127 (36.22%)  46 37/115 (32.17%)  37 30/122 (24.59%)  30 34/121 (28.10%)  34 18/63 (28.57%)  18
Headache * 1  7/127 (5.51%)  10 6/115 (5.22%)  6 6/122 (4.92%)  12 3/121 (2.48%)  3 1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal pain * 1  5/127 (3.94%)  5 6/115 (5.22%)  8 2/122 (1.64%)  2 6/121 (4.96%)  7 2/63 (3.17%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00952276     History of Changes
Other Study ID Numbers: FUF16
UTN: U1111-1111-4882
First Submitted: August 3, 2009
First Posted: August 6, 2009
Results First Submitted: August 26, 2011
Results First Posted: October 3, 2011
Last Update Posted: October 3, 2011