Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00938392
First received: July 9, 2009
Last updated: June 7, 2012
Last verified: April 2012
Results First Received: April 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza Infection
Interventions: Biological: GSK investigational FluNG vaccine GSK2186877A, aged lot
Biological: GSK investigational FluNG vaccine GSK2186877A, fresh lot

  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
Two subjects enrolled in the study did not receive any vaccination, and as such are not accounted for as started.

Reporting Groups
  Description
FluNG Aged Group Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
FluNG Fresh Group Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).

Participant Flow:   Overall Study
    FluNG Aged Group     FluNG Fresh Group  
STARTED     362     362  
COMPLETED     360     358  
NOT COMPLETED     2     4  
Adverse Event                 0                 1  
Withdrawal by Subject                 0                 1  
Lost to Follow-up                 2                 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
FluNG Aged Group Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
FluNG Fresh Group Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
Total Total of all reporting groups

Baseline Measures
    FluNG Aged Group     FluNG Fresh Group     Total  
Number of Participants  
[units: participants]
  362     362     724  
Age  
[units: Years]
Mean ± Standard Deviation
     
Years     73.3  ± 6.09     73.5  ± 6.36     73.4  ± 6.22  
Gender  
[units: Subjects]
     
Female     239     243     482  
Male     123     119     242  



  Outcome Measures
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1.  Primary:   Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains   [ Time Frame: At Days 0 and 21 ]

2.  Secondary:   Number of Subjects Seropositive Against the 3 Vaccine Strains   [ Time Frame: At Days 0 and 21 ]

3.  Secondary:   Number of Subjects Seroconverted for the 3 Vaccine Strains   [ Time Frame: At Day 21 ]

4.  Secondary:   Seroconversion Factor for the 3 Vaccine Strains   [ Time Frame: At Day 21 ]

5.  Secondary:   Number of Subjects Seroprotected for the 3 Vaccine Strains   [ Time Frame: At Days 0 and 21 ]

6.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7-day post-vaccination period ]

7.  Secondary:   Duration of Solicited Local and General Symptoms   [ Time Frame: During the 7-day post-vaccination period ]

8.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: During the 21-day post-vaccination period ]

9.  Secondary:   Number of Subjects Reporting Adverse Events of Specific Interest (AESI)   [ Time Frame: During the 21-day post-vaccination period ]

10.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (up to Day 21) ]


  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


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00938392     History of Changes
Other Study ID Numbers: 112662
Study First Received: July 9, 2009
Results First Received: April 19, 2012
Last Updated: June 7, 2012
Health Authority: Slovakia: State Institute for Drug Control
Estonia: State Agency of Medicines