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A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

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ClinicalTrials.gov Identifier: NCT00952419
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : July 11, 2011
Last Update Posted : April 14, 2016
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
Biological: Normal saline solution (placebo)
Enrollment 474
Recruitment Details Participants were enrolled from 06 August 2009 to 13 August 2009 at 19 US clinical centers.
Pre-assignment Details A total of 474 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 Placebo Group
Hide Arm/Group Description Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. Participants who received a dose of 15 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 215 208 51
Completed 209 198 51
Not Completed 6 10 0
Reason Not Completed
Adverse Event             2             0             0
Protocol Violation             3             7             0
Withdrawal by Subject             1             3             0
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 Placebo Group Total
Hide Arm/Group Description Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. Participants who received a dose of 15 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 215 208 51 474
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 208 participants 51 participants 474 participants
<=18 years
215
 100.0%
208
 100.0%
51
 100.0%
474
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 215 participants 208 participants 51 participants 474 participants
4.1  (2.8) 4.3  (2.8) 3.7  (2.7) 4.2  (2.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 208 participants 51 participants 474 participants
Female
111
  51.6%
99
  47.6%
24
  47.1%
234
  49.4%
Male
104
  48.4%
109
  52.4%
27
  52.9%
240
  50.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 215 participants 208 participants 51 participants 474 participants
215 208 51 474
1.Primary Outcome
Title Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Hide Description Pre- 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 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of 15 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 92 87 23
Measure Type: Number
Unit of Measure: Participants
Pre-Vaccination 1 (Day 0) Titers at ≥ 10 1/dil 5 2 0
Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil 72 79 0
Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil 90 87 1
2.Primary Outcome
Title Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Hide Description Seroprotection: Antibody titer of ≥ 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 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of 15 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 92 87 23
Measure Type: Number
Unit of Measure: Participants
Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil 5 2 0
Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil 43 42 0
Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil 84 86 1
3.Primary Outcome
Title Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
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 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of 15 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 92 87 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Pre-Vaccination 1 (Day 0) GMT
5.99
(5.10 to 7.04)
5.48
(4.84 to 6.20)
5.00
(5.00 to 5.00)
Post-Vaccination 1 (Day 21) GMT
33.3
(23.8 to 46.5)
45.1
(32.8 to 62.0)
5.08
(4.92 to 5.24)
Post-Vaccination 2 (Day 42) GMT
368
(271 to 500)
586
(451 to 763)
5.64
(4.39 to 7.24)
4.Primary Outcome
Title Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 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 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of 15 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 98 91 24
Measure Type: Number
Unit of Measure: Participants
Pre-Vaccination 1(Day 0) Titers at ≥ 10 1/dil 7 4 7
Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil 91 88 8
Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil 98 91 8
5.Primary Outcome
Title Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 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
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 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of 15 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 98 91 24
Measure Type: Number
Unit of Measure: Participants
Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil 5 3 5
Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil 64 68 5
Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil 95 90 6
6.Primary Outcome
Title Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 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
Antibody titers were assessed in the per-protocol population.
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of 15 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 98 91 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Pre-Vaccination 1 (Day 0) GMT
6.01
(5.20 to 6.94)
5.54
(5.03 to 6.10)
11.9
(6.17 to 22.9)
Post-Vaccination 1 (Day 21) GMT
74.8
(53.5 to 105)
104
(77.1 to 140)
12.1
(6.53 to 22.3)
Post-Vaccination 2 (Day 42) GMT
459
(348 to 605)
586
(454 to 756)
14.3
(7.02 to 29.3)
7.Primary Outcome
Title Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months
Hide Description Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
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 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of 15 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 61 56 18
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction - Any Dose 33 23 11
Grade (Grd) 3 Injection Site Reaction - Any Dose 1 1 0
Any Tenderness - Post Dose 1 24 14 5
Any Tenderness - Post Dose 2 19 11 7
Any Tenderness - Any Dose 28 20 10
Grd 3 Tenderness-Crying or movement less, Any Dose 0 1 0
Any Erythema - Post Dose 1 13 4 1
Any Erythema - Post Dose 2 12 5 2
Any Erythema - Any Dose 19 7 3
Grade 3 Erythema (≥ 5 cm) Any Dose 0 0 0
Any Swelling - Post Dose 1 4 5 0
Any Swelling - Post Dose 2 3 3 1
Any Swelling - Any Dose 6 6 1
Grade 3 Swelling (≥ 5 cm) Any Dose 0 0 0
Any Induration - Post Dose 1 6 3 1
Any Induration - Post Dose 2 4 3 0
Any Induration - Any Dose 6 5 1
Grade 3 Induration (≥ 5 cm) Any Dose 0 0 0
Any Ecchymosis - Post Dose 1 3 3 0
Any Ecchymosis - Post Dose 2 2 2 0
Any Ecchymosis - Any Dose 4 4 0
Grade 3 Ecchymosis (≥ 5 cm) Any Dose 1 0 0
Any Solicited Systemic Reaction - Any Dose 31 32 11
Any Grade 3 Solicited Systemic Reaction - Any Dose 3 4 0
Any Fever - Post Dose 1 6 2 0
Any Fever - Post Dose 2 0 5 1
Any Fever - Any Dose 6 6 1
Grade 3 Fever ( ≥102.1 ºF or ≥39.0 ºC) - Any Dose 0 1 0
Any Vomiting - Post Dose 1 1 4 0
Any Vomiting - Post Dose 2 2 3 0
Any Vomiting - Any Dose 3 6 0
Grade 3 Vomiting (> 6 episodes/24 hr) Any Dose 0 3 0
Any Crying Abnormal - Post Dose 1 17 12 5
Any Crying Abnormal - Post Dose 2 8 9 4
Any Crying Abnormal - Any Dose 20 14 7
Grade 3 Crying Abnormal (>3 hr) Any Dose 3 2 0
Any Drowsiness - Post Dose 1 8 11 3
Any Drowsiness - Post Dose 2 8 7 2
Any Drowsiness - Any Dose 11 11 3
Grade 3 Drowsiness (Sleeps most of time) Any Dose 0 1 0
Any Appetite Lost - Post Dose 1 8 12 3
Any Appetite Lost - Post Dose 2 5 9 3
Any Appetite Lost - Any Dose 10 14 4
Grd 3 Appetite Lost (Refused 3 meals) Any Dose 0 1 0
Any Irritability - Post Dose 1 23 22 7
Any Irritability - Post Dose 2 14 17 6
Any Irritability - Any Dose 26 25 9
Grade 3 Irritability (Inconsolable) Any Dose 0 2 0
8.Primary Outcome
Title Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months
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.
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 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of 15 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 44 42 8
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction - Any Dose 19 20 5
Grade (Grd) 3 Injection Site Reaction - Any Dose 0 2 0
Any Pain - Post Dose 1 12 12 3
Any Pain - Post Dose 2 10 16 2
Any Pain - Any Dose 17 19 3
Grade 3 Pain (Incapacitating) - Any Dose 0 2 0
Any Erythema - Post Dose 1 5 7 3
Any Erythema - Post Dose 2 3 9 1
Any Erythema - Any Dose 6 12 3
Grade 3 Erythema (≥ 5 cm) Any Dose 0 0 0
Any Swelling - Post Dose 1 1 3 0
Any Swelling - Post Dose 2 0 3 0
Any Swelling - Any Dose 1 4 0
Grade 3 Swelling (≥ 5 cm) Any Dose 0 0 0
Any Induration - Post Dose 1 2 4 1
Any Induration - Post Dose 2 1 3 1
Any Induration - Any Dose 2 6 1
Grade 3 Induration (≥ 5 cm) Any Dose 0 0 0
Any Ecchymosis - Post Dose 1 1 3 2
Any Ecchymosis - Post Dose 2 2 3 0
Any Ecchymosis - Any Dose 3 6 2
Grade 3 Ecchymosis (≥ 5 cm) Any Dose 0 0 0
Any Solicited Systemic Reaction - Any Dose 14 13 3
Any Grade 3 Solicited Systemic Reaction - Any Dose 1 2 1
Any Fever - Post Dose 1 1 1 1
Any Fever - Post Dose 2 3 1 0
Any Fever - Any Dose 4 2 1
Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) -Any Dose 1 1 1
Any Headache - Post Dose 1 1 1 1
Any Headache - Post Dose 2 0 1 1
Any Headache - Any Dose 1 2 1
Grd 3 Headache (Prevents daily activity) Any Dose 0 0 0
Any Malaise - Post Dose 1 7 6 3
Any Malaise - Post Dose 2 5 6 2
Any Malaise - Any Dose 10 9 3
Grd 3 Malaise (Prevents daily activity) Any Dose 1 1 0
Any Myalgia - Post Dose 1 4 3 2
Any Myalgia - Post Dose 2 0 2 2
Any Myalgia - Any Dose 4 5 2
Grd 3 Myalgia (Prevents Daily Activity) Any Dose 0 0 0
Any Shivering - Post Dose 1 1 1 0
Any Shivering - Post Dose 2 0 0 0
Any Shivering - Any Dose 1 1 0
Grade 3 Shivering (Prevents activity) - Any Dose 0 0 0
9.Primary Outcome
Title Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 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.
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 Placebo Group
Hide Arm/Group Description:
Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Participants who received a dose of 15 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 114 106 25
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction - Any Dose 70 59 16
Grade 3 Injection Site Reaction - Any Dose 3 3 0
Any Pain - Post Dose 1 48 42 12
Any Pain - Post Dose 2 34 31 8
Any Pain - Any Dose 63 54 16
Grade 3 Pain (Incapacitating) - Any Dose 2 0 0
Any Erythema - Post Dose 1 14 14 2
Any Erythema - Post Dose 2 10 5 2
Any Erythema - Any Dose 19 15 2
Grade 3 Erythema (≥ 5 cm) Any Dose 1 1 0
Any Swelling - Post Dose 1 5 10 1
Any Swelling - Post Dose 2 5 3 0
Any Swelling - Any Dose 8 11 1
Grade 3 Swelling (≥ 5 cm) Any Dose 1 3 0
Any Induration - Post Dose 1 7 8 4
Any Induration - Post Dose 2 7 2 0
Any Induration - Any Dose 11 8 4
Grade 3 Induration (≥ 5 cm) Any Dose 1 0 0
Any Ecchymosis - Post Dose 1 9 9 1
Any Ecchymosis - Post Dose 2 6 4 1
Any Ecchymosis - Any Dose 13 11 2
Grade 3 Ecchymosis (≥ 5 cm) Any Dose 0 0 0
Any Solicited Systemic Reaction - Any Dose 51 38 12
Any Grade 3 Solicited Systemic Reaction - Any Dose 5 7 2
Any Fever - Post Dose 1 2 1 1
Any Fever - Post Dose 2 4 5 1
Any Fever - Any Dose 6 6 2
Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose 1 3 1
Any Headache - Post Dose 1 15 11 5
Any Headache - Post Dose 2 13 10 3
Any Headache - Any Dose 23 19 7
Gr 3 Headache (Prevents daily activity) Any Dose 0 4 0
Any Malaise - Post Dose 1 18 12 7
Any Malaise - Post Dose 2 16 14 5
Any Malaise - Any Dose 29 24 10
Gr 3 Malaise (Prevents daily activity) Any Dose 3 6 1
Any Myalgia - Post Dose 1 19 9 1
Any Myalgia - Post Dose 2 14 11 3
Any Myalgia - Any Dose 32 18 3
Gr 3 Malaise (Prevents daily activity) Any Dose 2 0 0
Any Shivering - Post Dose 1 1 3 1
Any Shivering - Post Dose 2 0 5 1
Any Shivering - Any Dose 1 8 2
Grade 3 Shivering (Prevents activity) - Any Dose 1 2 0
Time Frame Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 Placebo Group
Hide Arm/Group Description Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. Participants who received a dose of 15 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 Placebo Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/219 (0.46%)      0/204 (0.00%)      1/51 (1.96%)    
Infections and infestations       
Furuncle * 1  1/219 (0.46%)  1 0/204 (0.00%)  0 0/51 (0.00%)  0
Injury, poisoning and procedural complications       
Humerus fracture * 1  0/219 (0.00%)  0 0/204 (0.00%)  0 1/51 (1.96%)  1
*
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%
A/H1N1 Vaccine Group 1 A/H1N1 Vaccine Group 2 Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   110/219 (50.23%)      104/204 (50.98%)      27/51 (52.94%)    
Gastrointestinal disorders       
Vomiting  1  3/61 (4.92%)  6/55 (10.91%)  0/18 (0.00%) 
General disorders       
Pyrexia * 1  10/219 (4.57%)  12/204 (5.88%)  1/51 (1.96%) 
Injection site pain  1  80/156 (51.28%)  73/145 (50.34%)  19/33 (57.58%) 
Injectiuon site tenderness  1  28/61 (45.90%)  20/55 (36.36%)  10/18 (55.56%) 
Injection site erythema  1  44/217 (20.28%)  34/201 (16.92%)  8/51 (15.69%) 
Injection site swelling  1  15/217 (6.91%)  21/201 (10.45%)  2/51 (3.92%) 
Injection site induration  1  19/217 (8.76%)  19/201 (9.45%)  6/51 (11.76%) 
Injection site ecchymosis  1  20/217 (9.22%)  21/201 (10.45%)  4/51 (7.84%) 
Pyrexia (Fever)  1  16/217 (7.37%)  14/200 (7.00%)  4/51 (7.84%) 
Malaise  1  39/156 (25.00%)  33/145 (22.76%)  13/33 (39.39%) 
Shivering  1  2/156 (1.28%)  9/145 (6.21%)  2/33 (6.06%) 
Infections and infestations       
Upper respiratory tract infection * 1  8/219 (3.65%)  9/204 (4.41%)  6/51 (11.76%) 
Metabolism and nutrition disorders       
Appetite lost  1  10/61 (16.39%)  14/55 (25.45%)  4/18 (22.22%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  36/156 (23.08%)  23/145 (15.86%)  5/33 (15.15%) 
Nervous system disorders       
Headache  1  24/156 (15.38%)  21/145 (14.48%)  8/33 (24.24%) 
Drowsiness  1  11/61 (18.03%)  11/55 (20.00%)  3/18 (16.67%) 
Psychiatric disorders       
Crying abnormal  1  20/61 (32.79%)  14/55 (25.45%)  7/18 (38.89%) 
Irritability  1  26/61 (42.62%)  25/55 (45.45%)  9/18 (50.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  34/219 (15.53%)  22/204 (10.78%)  3/51 (5.88%) 
Rhinorrhoea * 1  29/219 (13.24%)  22/204 (10.78%)  4/51 (7.84%) 
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00952419     History of Changes
Other Study ID Numbers: FUF15
UTN: U1111-1111-4713
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: April 14, 2016