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
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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 healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled and vaccinated between 07AUG2009 and 18AUG2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.

Participant Flow:   Overall Study
    H1N1 Vaccine 15 Mcg     H1N1 Vaccine 30 Mcg  
STARTED     202     204  
COMPLETED     198     202  
NOT COMPLETED     4     2  



  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
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
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Time Frame Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
Additional Description For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

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.

Serious Adverse Events
    H1N1 Vaccine 15 Mcg     H1N1 Vaccine 30 Mcg  
Total, serious adverse events      
# participants affected / at risk     6/202 (2.97%)     5/204 (2.45%)  
Cardiac disorders      
Ischaemic cardiomyopathy * 1    
# participants affected / at risk     1/202 (0.50%)     0/204 (0.00%)  
# events     1     0  
Atrial fibrillation * 1    
# participants affected / at risk     0/202 (0.00%)     1/204 (0.49%)  
# events     0     1  
Gastrointestinal disorders      
Umbilical hernia, obstructive * 1    
# participants affected / at risk     0/202 (0.00%)     1/204 (0.49%)  
# events     0     1  
General disorders      
Chest pain * 1    
# participants affected / at risk     0/202 (0.00%)     1/204 (0.49%)  
# events     0     1  
Infections and infestations      
Clostridium difficile colitis * 1    
# participants affected / at risk     1/202 (0.50%)     0/204 (0.00%)  
# events     1     0  
Injury, poisoning and procedural complications      
Post procedural complication * 1    
# participants affected / at risk     1/202 (0.50%)     0/204 (0.00%)  
# events     1     0  
Musculoskeletal and connective tissue disorders      
Osteoarthritis * 1    
# participants affected / at risk     1/202 (0.50%)     0/204 (0.00%)  
# events     1     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Lipoma * 1    
# participants affected / at risk     1/202 (0.50%)     0/204 (0.00%)  
# events     1     0  
Nervous system disorders      
Syncope * 1    
# participants affected / at risk     0/202 (0.00%)     1/204 (0.49%)  
# events     0     1  
Renal and urinary disorders      
Renal cyst * 1    
# participants affected / at risk     1/202 (0.50%)     0/204 (0.00%)  
# events     1     0  
Urinary incontinence * 1    
# participants affected / at risk     0/202 (0.00%)     1/204 (0.49%)  
# events     0     1  
Respiratory, thoracic and mediastinal disorders      
Respiratory failure * 1    
# participants affected / at risk     0/202 (0.00%)     1/204 (0.49%)  
# events     0     1  
Pulmonary embolism * 1    
# participants affected / at risk     0/202 (0.00%)     1/204 (0.49%)  
# events     0     1  
Surgical and medical procedures      
Thoracotomy * 1    
# participants affected / at risk     1/202 (0.50%)     0/204 (0.00%)  
# events     1     0  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (13.0)




  Other Adverse Events


  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