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CSL 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:
NCT00943488
First received: July 21, 2009
Last updated: October 25, 2012
Last verified: March 2010
Results First Received: March 10, 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 between 07AUG2009 and 21AUG2009

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     204     204  
COMPLETED     203     202  
NOT COMPLETED     1     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]
  204     204     408  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     102     98     200  
>=65 years     102     106     208  
Age  
[units: years]
Mean ± Standard Deviation
  57.9  ± 17.1     59.5  ± 15.9     58.7  ± 16.5  
Gender  
[units: participants]
     
Female     105     114     219  
Male     99     90     189  
Region of Enrollment  
[units: participants]
     
United States     204     204     408  



  Outcome Measures
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1.  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 ]

2.  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 ]

3.  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 ]

4.  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 ]

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

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

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

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

9.  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 8-10 Days Following 1 Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

10.  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 8-10 Days Following 1 Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

11.  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 ]

12.  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 ]

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

14.  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: 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 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of 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 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine   [ Time Frame: Day 0 prior to and Day 21 after first vaccination ]

17.  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: Day 0 prior to and 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 Days Following 2 Doses of H1N1 Vaccine.   [ Time Frame: Day 0 prior to first vaccination and Day 8-10 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: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]
  Hide Outcome Measure 19

Measure Type Secondary
Measure Title 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.
Measure Description Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8-10 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.
Time Frame Day 0 prior to first vaccination and Day 8-10 after the second 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.
Participants were included in the analyses if they received the both vaccinations, with the second within 4 days of the window, and had blood collected at the timepoint. Analysis was as treated, restricted to age stratum. One participant was excluded due to presumed H1N1 infection, and three due to receiving non-study vaccines prior to the visit.

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.

Measured Values
    H1N1 Vaccine 15 Mcg     H1N1 Vaccine 30 Mcg  
Number of Participants Analyzed  
[units: participants]
  97     104  
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.  
[units: Participants]
  56     71  

No statistical analysis provided for 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.



20.  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 21 Days Following 2 Doses of H1N1 Vaccine.   [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

21.  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: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

22.  Secondary:   Number of Participants in the 18-64 Year Age Stratum With a Serum 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 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 ]

24.  Secondary:   Number of Participants in the 18-64 Year Age Stratum With a Serum 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 ]

25.  Secondary:   Number of Participants in the 65 Years and Older Age Stratum With a Serum 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
No text entered.


  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.


Results Point of Contact:  
Name/Title: Patricia Winokur, MD
Organization: Carver College of Medicine, University of Iowa
phone: 319-384-1735
e-mail: patricia-winokur@uiowa.edu


Publications of Results:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00943488     History of Changes
Other Study ID Numbers: 09-0043, N01AI80008C
Study First Received: July 21, 2009
Results First Received: March 10, 2011
Last Updated: October 25, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board