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Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00980005
First received: September 17, 2009
Last updated: June 14, 2012
Last verified: June 2012
Results First Received: January 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Influenza Infection
Interventions: Biological: GSK investigational vaccine GSK1557482A
Biological: Fluzone®

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were stratified by age-strata: 3-4, 5-8 and 9-17 years and received vaccine according to their priming status: primed subjects received a 2-dose priming immunization in a previous season, whereas unprimed subjects had not. Blood samples: at Days 0 - 28 for primed subjects and subjects 9-17 years and at Days 0-56 for unprimed subjects.

Reporting Groups
  Description
Flulaval Group

subjects received Flulaval™ vaccine according to their priming status and age:

  • 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
  • 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
Fluzone Group

subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:

  • 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
  • 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.

Participant Flow:   Overall Study
    Flulaval Group     Fluzone Group  
STARTED     1055     1061  
COMPLETED     1008     998  
NOT COMPLETED     47     63  
Withdrawal by Subject                 6                 17  
Lost to Follow-up                 37                 43  
Unspecified                 4                 3  



  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
Flulaval Group

subjects received Flulaval™ vaccine according to their priming status and age:

  • 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
  • 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
Fluzone Group

subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:

  • 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
  • 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
Total Total of all reporting groups

Baseline Measures
    Flulaval Group     Fluzone Group     Total  
Number of Participants  
[units: participants]
  1055     1061     2116  
Age  
[units: Years]
Mean ± Standard Deviation
     
Years     7.8  ± 4.18     7.8  ± 4.10     7.8  ± 4.14  
Gender  
[units: Subjects]
     
Female     500     496     996  
Male     555     565     1120  



  Outcome Measures
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1.  Primary:   Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.   [ Time Frame: At Day 0 and 28 after last vaccine dose. ]

2.  Primary:   Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.   [ Time Frame: At Day 28 after last vaccine dose. ]

3.  Secondary:   Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.   [ Time Frame: At Day 0 and 28 after last vaccine dose. ]

4.  Secondary:   Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.   [ Time Frame: At Day 28 after last vaccine dose. ]

5.  Secondary:   Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.   [ Time Frame: At Day 0 and 28 after last vaccine dose. ]

6.  Secondary:   Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.   [ Time Frame: At Day 0 and 28 after last vaccine dose. ]

7.  Secondary:   Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.   [ Time Frame: At Day 0 and at Day 28 after last vaccine dose ]

8.  Secondary:   Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.   [ Time Frame: At Day 0 and at Day 28 after last vaccine dose ]

9.  Secondary:   Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).   [ Time Frame: During a 4-day follow-up period (Days 0-3) after vaccination. ]

10.  Secondary:   Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).   [ Time Frame: During a 4-day follow-up period (Days 0-3) after vaccination. ]

11.  Secondary:   Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).   [ Time Frame: During a 4-day follow-up period (Days 0-3) after vaccination. ]

12.  Secondary:   Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.   [ Time Frame: During a 4-day follow-up period (Days 0-3) after vaccination. ]

13.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).   [ Time Frame: During a 28 day follow-up period (Days 0-27) after vaccination. ]

14.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.   [ Time Frame: During a 28 day follow-up period (Days 0-27) after vaccination. ]

15.  Secondary:   Number of Subjects Reporting Medically Attended Adverse Events (MAEs).   [ Time Frame: During the entire study period (From Day 0 up to Day 180). ]

16.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs).   [ Time Frame: During the entire study period (From Day 0 up to Day 180). ]


  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
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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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00980005     History of Changes
Other Study ID Numbers: 112999
Study First Received: September 17, 2009
Results First Received: January 20, 2012
Last Updated: June 14, 2012
Health Authority: United States: Food and Drug Administration