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

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ClinicalTrials.gov Identifier: NCT00953524
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : July 11, 2011
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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 (7.5 µg of HA)
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)
Biological: Normal saline solution (placebo)
Enrollment 849
Recruitment Details Participants were enrolled from 06 August 2009 to 07 August 2009 at 15 US clinical centers.
Pre-assignment Details A total of 849 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Hide Arm/Group Description Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Period Title: Overall Study
Started 249 254 247 99
Completed 227 239 233 91
Not Completed 22 15 14 8
Reason Not Completed
Adverse Event             2             0             1             2
Protocol Violation             18             10             11             6
Lost to Follow-up             0             1             1             0
Withdrawal by Subject             2             4             1             0
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group Total
Hide Arm/Group Description Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. Total of all reporting groups
Overall Number of Baseline Participants 249 254 247 99 849
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 254 participants 247 participants 99 participants 849 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
150
  60.2%
152
  59.8%
148
  59.9%
49
  49.5%
499
  58.8%
>=65 years
99
  39.8%
102
  40.2%
99
  40.1%
50
  50.5%
350
  41.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 249 participants 254 participants 247 participants 99 participants 849 participants
52.8  (19.2) 53.4  (18.9) 54.4  (18.4) 56.4  (18.1) 53.4  (18.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 254 participants 247 participants 99 participants 849 participants
Female
140
  56.2%
143
  56.3%
145
  58.7%
57
  57.6%
485
  57.1%
Male
109
  43.8%
111
  43.7%
102
  41.3%
42
  42.4%
364
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 249 participants 254 participants 247 participants 99 participants 849 participants
249 254 247 99 849
1.Primary Outcome
Title Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Hide Description Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time Frame Pre-vaccination (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.
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Overall Number of Participants Analyzed 124 128 132 45
Measure Type: Number
Unit of Measure: Participants
Pre-Vaccination 1 (Day 0) Titers at ≥ 10 69 70 61 23
Post-Vaccination 1 (Day 21) Titers at ≥ 10 124 127 132 21
Post-Vaccination 2 (Day 42) Titers at ≥ 10 124 128 132 22
2.Primary Outcome
Title Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Hide Description Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time Frame Pre-vaccination (Day 0) and Day 21 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in the per-protocol population.
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Overall Number of Participants Analyzed 124 128 132 45
Measure Type: Number
Unit of Measure: Participants
Pre-Vaccination 1 (Day 0) Titers at ≥ 40 27 37 32 11
Post-Vaccination 1 (Day 21) Titers at ≥ 40 118 126 132 10
Post-Vaccination 2 (Day 42) Titers at ≥ 40 124 127 131 11
3.Primary Outcome
Title Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Hide Description Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time Frame Pre-vaccination (Day 0) and 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in the per-protocol population.
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Overall Number of Participants Analyzed 124 128 132 45
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Pre-Vaccination 1 (Day 0) GMT
14.5
(11.6 to 18.1)
17.3
(13.5 to 22.1)
14.1
(11.0 to 18.0)
14.0
(9.31 to 21.2)
Post-Vaccination 1 (Day 21) GMT
708
(555 to 903)
1362
(1073 to 1729)
1526
(1229 to 1895)
13.1
(8.89 to 19.3)
Post-Vaccination 2 (Day 42) GMT
800
(650 to 986)
1329
(1059 to 1669)
1331
(1082 to 1638)
13.5
(9.23 to 19.8)
4.Primary Outcome
Title Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
Hide Description Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time Frame Pre-vaccination (Day 0) and 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre- and post-vaccination antibody titers were assessed in the per-protocol population.
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Overall Number of Participants Analyzed 87 87 85 39
Measure Type: Number
Unit of Measure: Participants
Pre-Vaccination 1 (Day 0) Titers at ≥ 10 64 54 60 24
Post-Vaccination 1 (Day 21) Titers at ≥ 10 87 87 85 23
Post-Vaccination 2 (Day 42) Titers at ≥ 10 87 87 85 26
5.Primary Outcome
Title Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Hide Description Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time Frame Pre-vaccination (Day 0) and 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pre- and post-vaccination antibody titers were assessed in the per-protocol population.
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Overall Number of Participants Analyzed 87 87 85 39
Measure Type: Number
Unit of Measure: Participants
Pre-Vaccination 1 (Day 0) Titers at ≥ 40 21 21 24 10
Post-Vaccination 1 (Day 21) Titers at ≥ 40 82 80 80 9
Post-Vaccination 2 (Day 42) Titers at ≥ 40 85 83 85 10
6.Primary Outcome
Title Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Hide Description Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Time Frame Pre-vaccination (Day 0) and 21 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody titers were assessed in the per-protocol population.
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Overall Number of Participants Analyzed 87 87 85 39
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Pre-Vaccination 1 (Day 0) GMT
19.1
(14.8 to 24.5)
14.7
(12.0 to 18.1)
18.3
(14.1 to 23.7)
17.5
(11.0 to 27.9)
Post-Vaccination 1 (Day 21) GMT
319
(229 to 443)
423
(298 to 600)
578
(408 to 819)
17.5
(11.2 to 27.4)
Post-Vaccination 2 (Day 42) GMT
359
(268 to 481)
416
(311 to 556)
604
(442 to 827)
19.0
(12.1 to 29.7)
7.Primary Outcome
Title Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Hide Description 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).
Time Frame Days 0 to 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.
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Overall Number of Participants Analyzed 149 152 149 49
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction - Any Dose 65 60 73 9
Grade 3 Injection Site Reaction - Any Dose 4 1 2 0
Any Pain - Post Dose 1 53 43 48 8
Any Pain - Post Dose 2 39 42 56 4
Any Pain - Any Dose 64 59 72 9
Grade 3 Pain (Prevents daily activity) - Any Dose 4 1 2 0
Any Erythema - Post Dose 1 0 0 0 0
Any Erythema - Post Dose 2 0 0 2 0
Any Erythema - Any Dose 0 0 2 0
Grade 3 Erythema (> 10 cm) - Any Dose 0 0 0 0
Any Swelling - Post Dose 1 1 2 2 0
Any Swelling - Post Dose 2 0 2 2 0
Any Swelling - Any Dose 1 3 3 0
Grade 3 Swelling (> 10 cm) - Any Dose 0 0 0 0
Any Induration - Post Dose 1 1 1 1 0
Any Induration - Post Dose 2 0 2 2 0
Any Induration - Any Dose 1 2 2 0
Grade 3 Induration (> 10 cm) - Any Dose 0 0 0 0
Any Ecchymosis - Post Dose 1 1 1 0 0
Any Ecchymosis - Post Dose 2 1 1 1 0
Any Ecchymosis - Any Dose 2 1 1 0
Grade 3 Ecchymosis (> 10 cm) - Any Dose 0 0 0 0
Any Solicited Systemic Reaction - Any Dose 81 73 78 24
Any Grade 3 Solicited Systemic Reaction - Any Dose 10 6 3 4
Any Fever - Post Dose 1 1 1 2 1
Any Fever - Post Dose 2 1 0 1 0
Any Fever - Any Dose 2 1 2 1
Grade 3 Fever (≥ 102.1 F or ≥ 39.0 C) - Any Dose 1 0 0 1
Any Headache - Post Dose 1 48 48 40 16
Any Headache - Post Dose 2 36 21 31 11
Any Headache - Any Dose 60 55 53 19
Grd 3 Headache (Prevents daily activity), Any Dose 5 5 2 3
Any Malaise - Post Dose 1 34 23 27 9
Any Malaise - Post Dose 2 22 15 25 6
Any Malaise - Any Dose 43 31 42 13
Grd 3 Malaise (Prevents daily activity) - Any Dose 6 3 2 2
Any Myalgia - Post Dose 1 43 30 33 11
Any Myalgia - Post Dose 2 22 16 26 5
Any Myalgia - Any Dose 49 34 49 13
Grd 3 Myalgia (Prevents daily activity) - Any Dose 6 2 0 2
Any Shivering - Post Dose 1 10 2 8 2
Any Shivering - Post Dose 2 2 0 3 0
Any Shivering - Any Dose 12 2 9 2
Grade 3 Shivering (Prevents activity) - Any Dose 1 0 0 1
8.Primary Outcome
Title Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Hide Description 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).
Time Frame Days 0 to 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.
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Overall Number of Participants Analyzed 99 102 99 50
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction - Any Dose 20 19 27 2
Grade 3 Injection Site Reaction - Any Dose 0 0 1 0
Any Pain - Post Dose 1 10 12 16 0
Any Pain - Post Dose 2 10 14 16 2
Any Pain - Any Dose 18 19 24 2
Grade 3 Pain (Prevents daily activity) - Any Dose 0 0 1 0
Any Erythema - Post Dose 1 1 0 1 0
Any Erythema - Post Dose 2 1 0 2 0
Any Erythema - Any Dose 2 0 3 0
Grade 3 Erythema (> 10 cm) - Any Dose 0 0 0 0
Any Swelling - Post Dose 1 0 0 2 0
Any Swelling - Post Dose 2 0 0 2 1
Any Swelling - Any Dose 0 0 3 1
Grade 3 Swelling (> 10 cm) - Any Dose 0 0 0 0
Any Induration - Post Dose 1 0 0 0 0
Any Induration - Post Dose 2 0 1 0 0
Any Induration - Any Dose 0 1 0 0
Grade 3 Induration (> 10 cm) - Any Dose 0 0 0 0
Any Ecchymosis - Post Dose 1 2 0 2 0
Any Ecchymosis - Post Dose 2 0 1 0 1
Any Ecchymosis - Any Dose 2 1 2 1
Grade 3 Ecchymosis (> 10 cm) - Any Dose 0 0 0 0
Any Solicited Systemic Reaction - Any Dose 28 22 32 13
Any Grade 3 Solicited Systemic Reaction - Any Dose 2 1 1 0
Any Fever - Post Dose 1 0 0 1 1
Any Fever - Post Dose 2 0 0 0 1
Any Fever - Any Dose 0 0 1 2
Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose 0 0 0 0
Any Headache - Post Dose 1 11 10 16 6
Any Headache - Post Dose 2 9 7 8 9
Any Headache - Any Dose 16 13 21 11
Grd 3 Headache (Prevents daily activity), Any Dose 1 0 0 0
Any Malaise - Post Dose 1 4 7 15 4
Any Malaise - Post Dose 2 11 4 7 5
Any Malaise - Any Dose 14 9 21 8
Grd 3 Malaise (Prevents daily activity) - Any Dose 1 0 1 0
Any Myalgia - Post Dose 1 7 9 11 2
Any Myalgia - Post Dose 2 5 10 8 5
Any Myalgia - Any Dose 11 16 17 6
Grd 3 Myalgia (Prevents daily activity) - Any Dose 1 1 1 0
Any Shivering - Post Dose 1 1 0 2 1
Any Shivering - Post Dose 2 2 3 0 2
Any Shivering - Any Dose 3 3 2 3
Grade 3 Shivering (Prevents activity) - Any Dose 1 0 0 0
Time Frame Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Hide Arm/Group Description Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
All-Cause Mortality
A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/248 (3.23%)      7/254 (2.76%)      7/248 (2.82%)      4/99 (4.04%)    
Cardiac disorders         
Angina Pectoris * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 1/248 (0.40%)  1 0/99 (0.00%)  0
Coronary artery disease * 1  0/248 (0.00%)  0 1/254 (0.39%)  1 2/248 (0.81%)  3 0/99 (0.00%)  0
Myocardial infarction * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 1/248 (0.40%)  1 0/99 (0.00%)  0
Gastrointestinal disorders         
Femoral hernia * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 0/248 (0.00%)  0 1/99 (1.01%)  1
Large intestine perforation * 1  0/248 (0.00%)  0 1/254 (0.39%)  1 0/248 (0.00%)  0 0/99 (0.00%)  0
General disorders         
Non-cardiac chest pain * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 1/248 (0.40%)  1 0/99 (0.00%)  0
Infections and infestations         
Cellulitis * 1  1/248 (0.40%)  1 0/254 (0.00%)  0 0/248 (0.00%)  0 0/99 (0.00%)  0
Diverticulitis * 1  0/248 (0.00%)  0 1/254 (0.39%)  2 0/248 (0.00%)  0 0/99 (0.00%)  0
Gastroenteritis * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 1/248 (0.40%)  1 0/99 (0.00%)  0
Gastroenteritis viral * 1  0/248 (0.00%)  0 1/254 (0.39%)  1 0/248 (0.00%)  0 0/99 (0.00%)  0
Pneumonia bacterial * 1  0/248 (0.00%)  0 1/254 (0.39%)  1 0/248 (0.00%)  0 0/99 (0.00%)  0
Injury, poisoning and procedural complications         
Ankle fracture * 1  1/248 (0.40%)  1 0/254 (0.00%)  0 0/248 (0.00%)  0 0/99 (0.00%)  0
Multiple fractures * 1  0/248 (0.00%)  0 1/254 (0.39%)  1 0/248 (0.00%)  0 0/99 (0.00%)  0
Skin laceration * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 1/248 (0.40%)  1 0/99 (0.00%)  0
Upper limb fracture * 1  1/248 (0.40%)  1 0/254 (0.00%)  0 0/248 (0.00%)  0 0/99 (0.00%)  0
Metabolism and nutrition disorders         
Diabetes mellitus * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 0/248 (0.00%)  0 1/99 (1.01%)  2
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion * 1  1/248 (0.40%)  1 0/254 (0.00%)  0 0/248 (0.00%)  0 0/99 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lung neoplasm malignan * 1  0/248 (0.00%)  0 1/254 (0.39%)  2 0/248 (0.00%)  0 0/99 (0.00%)  0
Non-Hodgkins lymphoma * 1  0/248 (0.00%)  0 1/254 (0.39%)  2 0/248 (0.00%)  0 0/99 (0.00%)  0
Oesophageal carcinoma * 1  1/248 (0.40%)  2 0/254 (0.00%)  0 0/248 (0.00%)  0 0/99 (0.00%)  0
Rectal cancer * 1  1/248 (0.40%)  2 0/254 (0.00%)  0 0/248 (0.00%)  0 0/99 (0.00%)  0
Sarcoma * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 1/248 (0.40%)  1 0/99 (0.00%)  0
Nervous system disorders         
Carotid artery stenosis * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 1/248 (0.40%)  1 0/99 (0.00%)  0
Cerebrovascular accident * 1  0/248 (0.00%)  0 1/254 (0.39%)  1 0/248 (0.00%)  0 0/99 (0.00%)  0
Global amnesia * 1  1/248 (0.40%)  1 0/254 (0.00%)  0 0/248 (0.00%)  0 0/99 (0.00%)  0
Myasthenia gravis * 1  1/248 (0.40%)  1 0/254 (0.00%)  0 0/248 (0.00%)  0 0/99 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pleural effusion * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 0/248 (0.00%)  0 1/99 (1.01%)  1
Vascular disorders         
Aortic aneurysm * 1  0/248 (0.00%)  0 0/254 (0.00%)  0 0/248 (0.00%)  0 1/99 (1.01%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 A/H1N1 Vaccine Group 3 Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   82/248 (33.06%)      78/254 (30.71%)      96/248 (38.71%)      30/99 (30.30%)    
General disorders         
Injection site pain † 1  82/242 (33.88%)  78/249 (31.33%)  96/246 (39.02%)  11/98 (11.22%) 
Malaise † 1  57/242 (23.55%)  40/249 (16.06%)  63/246 (25.61%)  21/99 (21.21%) 
Shivering † 1  15/242 (6.20%)  15/249 (6.02%)  11/246 (4.47%)  5/99 (5.05%) 
Musculoskeletal and connective tissue disorders         
Myalgia † 1  60/242 (24.79%)  50/249 (20.08%)  66/246 (26.83%)  19/99 (19.19%) 
Nervous system disorders         
Headache † 1  76/242 (31.40%)  68/249 (27.31%)  74/246 (30.08%)  30/99 (30.30%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
[Not Specified]
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
Publications of Results:
Plennevaux E, Sheldon E, Blatter M, Reeves-Hoché MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.
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Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00953524    
Other Study ID Numbers: FUF14
UTN: U1111-1111-4798 ( Other Identifier: WHO )
First Submitted: August 3, 2009
First Posted: August 6, 2009
Results First Submitted: June 8, 2011
Results First Posted: July 11, 2011
Last Update Posted: March 10, 2014