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Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00374842
First received: September 8, 2006
Last updated: October 6, 2016
Last verified: October 2016
Results First Received: March 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Fluarix™
Biological: GSK1247446A

  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
A total of 300 subjects were enrolled in the study. Study duration was of approximately 1 month (30 days) for all subjects.

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
GSK1247446A Formulation 1 Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK1247446A Formulation 2 Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Participant Flow:   Overall Study
    GSK1247446A Formulation 1 Group   GSK1247446A Formulation 2 Group   Fluarix Group
STARTED   100   100   100 
COMPLETED   100   100   100 
NOT COMPLETED   0   0   0 



  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
GSK1247446A Formulation 1 Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK1247446A Formulation 2 Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix Group Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
   GSK1247446A Formulation 1 Group   GSK1247446A Formulation 2 Group   Fluarix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 100   100   100   300 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.3  (13.94)   35.0  (13.26)   37.7  (13.75)   36.7  (13.65) 
Gender 
[Units: Participants]
       
Female   65   60   57   182 
Male   35   40   43   118 


  Outcome Measures
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1.  Primary:   Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.   [ Time Frame: At Day 0 and at Day 21. ]

2.  Primary:   Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.   [ Time Frame: At Day 0 and at Day 21. ]

3.  Primary:   Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed   [ Time Frame: At Day 21. ]

4.  Primary:   Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.   [ Time Frame: At Day 21. ]

5.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: Within the 7-day follow-up period (Days 0-6) after vaccination ]

6.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: Within the 7-day follow-up period (Days 0-6) after vaccination ]

7.  Secondary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: Within the 30-day follow-up period (Days 0-29) after vaccination ]

8.  Secondary:   Number of Subjects With Any and Related Serious Adverse Events (SAEs)   [ Time Frame: From study start to study end, from Day 0 to Day 30 ]


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00374842     History of Changes
Other Study ID Numbers: 108656
Study First Received: September 8, 2006
Results First Received: March 7, 2013
Last Updated: October 6, 2016
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment