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Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00943631
First received: July 21, 2009
Last updated: October 25, 2012
Last verified: March 2010
Results First Received: March 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Inactivated H1N1 Vaccine

  Participant Flow


  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.
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Reporting Groups
  Description
H1N1 Vaccine 15 Mcg Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
H1N1 Vaccine 30 Mcg Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Total Total of all reporting groups

Baseline Measures
    H1N1 Vaccine 15 Mcg     H1N1 Vaccine 30 Mcg     Total  
Number of Participants  
[units: participants]
  202     204     406  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     102     100     202  
>=65 years     100     104     204  
Age  
[units: years]
Mean ± Standard Deviation
  58.7  ± 17.1     59.6  ± 16.4     59.1  ± 16.7  
Gender  
[units: participants]
     
Female     103     112     215  
Male     99     92     191  
Region of Enrollment  
[units: participants]
     
United States     202     204     406  



  Outcome Measures
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1.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 180 after last vaccination ]

2.  Primary:   Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

3.  Primary:   Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

4.  Primary:   Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

5.  Primary:   Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

6.  Primary:   Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

7.  Primary:   Number of Participants Reporting Solicited Systemic Reactions Based on the Functional Grading Scale After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

8.  Primary:   Number of Participants Reporting Fever After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

9.  Primary:   Number of Participants Reporting Fever After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

10.  Primary:   Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine   [ Time Frame: Baseline and Day 8-10 after first vaccination ]

11.  Primary:   Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine   [ Time Frame: Baseline and Day 8-10 after first vaccination ]

12.  Primary:   Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine   [ Time Frame: Baseline and Day 21 after first vaccination ]

13.  Primary:   Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine   [ Time Frame: Baseline and Day 21 after first vaccination ]

14.  Primary:   Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

15.  Primary:   Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and at 8-10 Days Following 1 Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

16.  Primary:   Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine   [ Time Frame: Day 21 after first vaccination ]

17.  Primary:   Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine   [ Time Frame: Day 21 after first vaccination ]

18.  Secondary:   Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine   [ Time Frame: Baseline and Day 8-10 and 21 after the second vaccination ]

19.  Secondary:   Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine   [ Time Frame: Baseline and Day 8-10 after the second vaccination ]

20.  Secondary:   Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine   [ Time Frame: Baseline and Day 21 after the second vaccination ]

21.  Secondary:   Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 and 21 Days Following 2 Doses of H1N1 Vaccine   [ Time Frame: Day 8-10 and Day 21 after the second vaccination ]

22.  Secondary:   Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine   [ Time Frame: Day 8-10 after the second vaccination ]

23.  Secondary:   Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine   [ Time Frame: Day 21 after the second 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