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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00952276
First received: August 3, 2009
Last updated: August 26, 2011
Last verified: August 2011
Results First Received: August 26, 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 with adjuvant
Biological: Monovalent Subvirion A/H1N1 influenza vaccine
Biological: Normal saline solution

  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 29 October 2009 to 13 November 2009 at 14 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 548 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.

Reporting Groups
  Description
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Group 3: A/H1N1 Vaccine Formulation 3 Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Group 4: A/H1N1 Vaccine Formulation 4 Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Group 5: Placebo Participants who received a dose of placebo (normal saline) on Day 0

Participant Flow:   Overall Study
    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  
STARTED     127     115     122     121     63  
COMPLETED     126     115     122     120     63  
NOT COMPLETED     1     0     0     1     0  
Withdrawal by Subject                 1                 0                 0                 1                 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
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Group 3: A/H1N1 Vaccine Formulation 3 Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Group 4: A/H1N1 Vaccine Formulation 4 Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Group 5: Placebo Participants who received a dose of placebo (normal saline) on Day 0
Total Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  127     115     122     121     63     548  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     75     69     73     71     38     326  
>=65 years     52     46     49     50     25     222  
Age  
[units: Years]
Mean ± Standard Deviation
           
Age Continuous     54.0  ± 18.4     53.3  ± 18.7     51.9  ± 18.0     52.7  ± 19.9     54.7  ± 16.7     53.4  ± 18.34  
Gender  
[units: participants]
           
Female     79     65     66     68     45     323  
Male     48     50     56     53     18     225  
Region of Enrollment  
[units: Participants]
           
United States     127     115     122     121     63     548  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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   [ Time Frame: Day 0 and Day 21 post-vaccination ]

2.  Primary:   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   [ Time Frame: Day 0 and Day 21 post-vaccination ]

3.  Primary:   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   [ Time Frame: Day 0 and Day 21 post-vaccination ]

4.  Primary:   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   [ Time Frame: Day 0 and Day 21 post-vaccination ]

5.  Primary:   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   [ Time Frame: Day 0 and Day 21 post-vaccination ]

6.  Primary:   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   [ Time Frame: Day 0 and Day 21 post-vaccination ]

7.  Primary:   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   [ Time Frame: Day 0 up to Day 7 post-vaccination ]

8.  Primary:   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   [ Time Frame: Day 0 up to Day 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


No publications provided


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00952276     History of Changes
Other Study ID Numbers: FUF16, UTN: U1111-1111-4882
Study First Received: August 3, 2009
Results First Received: August 26, 2011
Last Updated: August 26, 2011
Health Authority: United States: Food and Drug Administration