Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00971425
First received: August 27, 2009
Last updated: March 15, 2011
Last verified: February 2011
Results First Received: February 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Influenza A Virus, H1N1 Subtype
Influenza Infection
Interventions: Biological: Pandemrix (GSK investigational influenza GSK2340272A vaccine)
Biological: Fluarix™
Biological: Placebo

  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
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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
Placebo-Pandemrix-Fluarix Group Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Fluarix-Pandemrix-Placebo Group Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.

Participant Flow:   Overall Study
    Placebo-Pandemrix-Fluarix Group     Fluarix-Pandemrix-Placebo Group  
STARTED     72     73  
COMPLETED     71     71  
NOT COMPLETED     1     2  
Adverse Event                 1                 1  
Withdrawal by Subject                 0                 1  



  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
Placebo-Pandemrix-Fluarix Group Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
Fluarix-Pandemrix-Placebo Group Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
Total Total of all reporting groups

Baseline Measures
    Placebo-Pandemrix-Fluarix Group     Fluarix-Pandemrix-Placebo Group     Total  
Number of Participants  
[units: participants]
  72     73     145  
Age  
[units: Years]
Mean ± Standard Deviation
  69.1  ± 5.16     69.7  ± 5.59     69.4  ± 5.37  
Gender  
[units: subjects]
     
Female     39     34     73  
Male     33     39     72  



  Outcome Measures
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1.  Primary:   Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain   [ Time Frame: At Day 42 ]

2.  Primary:   Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain   [ Time Frame: At Day 42 ]

3.  Primary:   Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain   [ Time Frame: At Day 42 ]

4.  Primary:   Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain   [ Time Frame: At Day 42 ]

5.  Primary:   Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain   [ Time Frame: At Day 42 ]

6.  Secondary:   Geometric Mean Titers (GMTs) of Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains   [ Time Frame: Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 ]

7.  Secondary:   Number of Subjects With a Titer Greater Than or Equal to 1:10 for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains   [ Time Frame: At Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 ]

8.  Secondary:   Number of Seroconverted Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains   [ Time Frame: At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains. ]

9.  Secondary:   Seroconversion Factor for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains   [ Time Frame: At Day 21, Month 6 and Month 12 for Pandemrix vaccine strain, and at Day 0/Day 63 for Fluarix vaccine strains. ]

10.  Secondary:   Number of Seroprotected Subjects for Antibodies Against Pandemrix Vaccine Strain and Fluarix Vaccine Strains   [ Time Frame: Day -21, Day 0, Day 21, Day 42, Day 63, Month 6 and Month 12 ]

11.  Secondary:   Number of Subjects With Solicited Local and General Symptoms After Administration of Pandemrix   [ Time Frame: During a 7-Day (Day 0-6) follow-up period after each administration of Pandemrix ]

12.  Secondary:   Number of Subjects With Solicited Local and General Symptoms After Administration of Placebo or Fluarix   [ Time Frame: During a 7-Day (Day 0-6) follow-up period after each administration of (at Day -21 and at Day 42) placebo or Fluarix ]

13.  Secondary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: During 21 days (Day 0-20) after each vaccination ]

14.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (Day 0-364) ]

15.  Secondary:   Number of Subjects With AEs of Specific Interest   [ Time Frame: During the entire study period (Day 0-364) ]


  Serious Adverse Events


  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 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.


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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00971425     History of Changes
Other Study ID Numbers: 113572
Study First Received: August 27, 2009
Results First Received: February 10, 2011
Last Updated: March 15, 2011
Health Authority: Germany: Paul-Ehrlich-Institut