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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
History of Changes
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
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  Baseline Characteristics
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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
  Show All Outcome Measures

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

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 7

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

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

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 ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 11

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 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16

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 ]
  Show Outcome Measure 17

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 ]
  Show Outcome Measure 18

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 ]
  Show Outcome Measure 19

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 ]
  Show Outcome Measure 20

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 ]
  Show Outcome Measure 21

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 ]
  Show Outcome Measure 22

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 ]
  Show Outcome Measure 23


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: Karen Kotloff, MD
Organization: Center for Vaccine Development, University of Maryland
phone: 401-706-5328
e-mail: kkotloff@medicine.umaryland.edu


Publications of Results:


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00943631     History of Changes
Other Study ID Numbers: 09-0053, N01AI80057C
Study First Received: July 21, 2009
Results First Received: March 17, 2011
Last Updated: October 25, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board