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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00953524
First received: August 3, 2009
Last updated: July 8, 2011
Last verified: July 2011
History of Changes
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 (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)

  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 07 August 2009 at 15 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 849 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 A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 2 Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 3 Participants who received a dose of A/H1N1 Vaccine (30 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     A/H1N1 Vaccine Group 3     Placebo Group  
STARTED     249     254     247     99  
COMPLETED     227     239     233     91  
NOT COMPLETED     22     15     14     8  
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  



  Baseline Characteristics
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Reporting Groups
  Description
A/H1N1 Vaccine Group 1 Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 2 Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 3 Participants who received a dose of A/H1N1 Vaccine (30 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     A/H1N1 Vaccine Group 3     Placebo Group     Total  
Number of Participants  
[units: participants]
 		  249     254     247     99     849  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     150     152     148     49     499  
>=65 years     99     102     99     50     350  
Age  
[units: Years]
Mean ± Standard Deviation 		  52.8  ± 19.2     53.4  ± 18.9     54.4  ± 18.4     56.4  ± 18.1     53.4  ± 18.9  
Gender  
[units: participants]
 		         
Female     140     143     145     57     485  
Male     109     111     102     42     364  
Region of Enrollment  
[units: participants]
 		         
United States     249     254     247     99     849  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years   [ Time Frame: Pre-vaccination (Day 0) and day 21 post-vaccination ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years   [ Time Frame: Pre-vaccination (Day 0) and Day 21 post-vaccination ]
  Show Outcome Measure 2

3.  Primary:   Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years   [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]
  Show Outcome Measure 3

4.  Primary:   Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years   [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]
  Hide Outcome Measure 4

Measure Type Primary
Measure Title Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
Measure 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  
Safety Issue No  

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.
Pre- and post-vaccination antibody titers were assessed in the per-protocol population.

Reporting Groups
  Description
A/H1N1 Vaccine Group 1 Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 2 Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 3 Participants who received a dose of A/H1N1 Vaccine (30 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.

Measured Values
    A/H1N1 Vaccine Group 1     A/H1N1 Vaccine Group 2     A/H1N1 Vaccine Group 3     Placebo Group  
Number of Participants Analyzed  
[units: participants]
 		  87     87     85     39  
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years  
[units: 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  

No statistical analysis provided for Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years



5.  Primary:   Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years   [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]
  Show Outcome Measure 5

6.  Primary:   Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years   [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]
  Show Outcome Measure 6

7.  Primary:   Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years   [ Time Frame: Days 0 to 7 post-vaccination ]
  Show Outcome Measure 7

8.  Primary:   Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years   [ Time Frame: Days 0 to 7 post-vaccination ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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


Publications of Results:


Responsible Party: Medical Monitor, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier: NCT00953524     History of Changes
Other Study ID Numbers: FUF14, UTN: U1111-1111-4798
Study First Received: August 3, 2009
Results First Received: June 8, 2011
Last Updated: July 8, 2011
Health Authority: United States: Food and Drug Administration