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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00952419
First received: August 3, 2009
Last updated: January 9, 2014
Last verified: January 2014
Results First Received: June 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 06 August 2009 to 13 August 2009 at 19 US clinical centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 474 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.

Reporting Groups
  Description
A/H1N1 Vaccine Group 1 Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 2 Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Placebo Group Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.

Participant Flow:   Overall Study
    A/H1N1 Vaccine Group 1     A/H1N1 Vaccine Group 2     Placebo Group  
STARTED     215     208     51  
COMPLETED     209     198     51  
NOT COMPLETED     6     10     0  
Adverse Event                 2                 0                 0  
Protocol Violation                 3                 7                 0  
Withdrawal by Subject                 1                 3                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
A/H1N1 Vaccine Group 1 Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 2 Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
Placebo Group Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Total Total of all reporting groups

Baseline Measures
    A/H1N1 Vaccine Group 1     A/H1N1 Vaccine Group 2     Placebo Group     Total  
Number of Participants  
[units: participants]
  215     208     51     474  
Age  
[units: participants]
       
<=18 years     215     208     51     474  
Between 18 and 65 years     0     0     0     0  
>=65 years     0     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation
  4.1  ± 2.8     4.3  ± 2.8     3.7  ± 2.7     4.2  ± 2.8  
Gender  
[units: participants]
       
Female     111     99     24     234  
Male     104     109     27     240  
Region of Enrollment  
[units: participants]
       
United States     215     208     51     474  



  Outcome Measures
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1.  Primary:   Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months   [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]

2.  Primary:   Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months   [ Time Frame: Pre-vaccination (Day 0) and Day 21 post-vaccination ]

3.  Primary:   Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months   [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]

4.  Primary:   Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years   [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]

5.  Primary:   Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years   [ Time Frame: Pre-vaccination (Day 0) and Day 21 post-vaccination ]

6.  Primary:   Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years   [ Time Frame: Pre-vaccination (Day 0) and Day 21 post-vaccination ]

7.  Primary:   Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months   [ Time Frame: Days 0 to 7 post-vaccination ]

8.  Primary:   Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months   [ Time Frame: Days 0 to 7 post-vaccination ]

9.  Primary:   Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years   [ Time Frame: Days 0 to 7 post vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00952419     History of Changes
Other Study ID Numbers: FUF15, UTN: U1111-1111-4713
Study First Received: August 3, 2009
Results First Received: June 8, 2011
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration