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A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01196975
First received: September 7, 2010
Last updated: November 21, 2012
Last verified: November 2012
Results First Received: November 21, 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
Interventions: Biological: Quadrivalent seasonal influenza vaccine GSK2282512A
Biological: FluLavalTM-VB
Biological: FluLavalTM-YB

  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
1703 of the 1707 subjects enrolled in the study were actually administered vaccination. The other 4 subjects were not vaccinated due to failing at meeting protocol specific criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
For some outcome measures, the subjects receiving the GSK2282512A vaccine, from Lot 1, 2 or 3, were pooled into one larger pooled group, the GSK2282512A Group, and/or groups were stratified into the 4 age categories: 18 to 60 years (18-60Y), 61 years and older (≥61Y), 18 to 64 years (18-64Y), and 65 years and older (≥ 65Y).

Reporting Groups
  Description
GSK2282512A 1 Group Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK2282512A 2 Group Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK2282512A 3 Group Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Victoria Strain FluLaval Group Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Yamagata Strain FluLaval Group Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Participant Flow:   Overall Study
    GSK2282512A 1 Group     GSK2282512A 2 Group     GSK2282512A 3 Group     Victoria Strain FluLaval Group     Yamagata Strain FluLaval Group  
STARTED     423     424     425     213     218  
COMPLETED     408     415     420     207     205  
NOT COMPLETED     15     9     5     6     13  
Adverse Event                 2                 2                 0                 0                 2  
Withdrawal by Subject                 2                 1                 0                 1                 0  
Lost to Follow-up                 11                 6                 5                 5                 11  



  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
GSK2282512A 1 Group Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
GSK2282512A 2 Group Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK2282512A 3 Group Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Victoria Strain FluLaval Group Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Yamagata Strain FluLaval Group Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
    GSK2282512A 1 Group     GSK2282512A 2 Group     GSK2282512A 3 Group     Victoria Strain FluLaval Group     Yamagata Strain FluLaval Group     Total  
Number of Participants  
[units: participants]
  423     424     425     213     218     1703  
Age  
[units: Years]
Mean ± Standard Deviation
  49.9  ± 19.49     50.4  ± 19.07     49.8  ± 20.10     50.8  ± 18.58     49.6  ± 19.34     50.1  ± 19.32  
Gender  
[units: Subjects]
           
Female     251     264     266     125     138     1044  
Male     172     160     159     88     80     659  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease   [ Time Frame: At Day 0 (D0) and at Day 21 (D21) post vaccination. ]

2.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata   [ Time Frame: At Day 0 (D0) and at Day 21 (D21) post vaccination. ]

3.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata   [ Time Frame: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination. ]

4.  Secondary:   Number of Subjects With Medically-attended Adverse Events (MAEs)   [ Time Frame: From the beginning of the study until study end (from Day 0 to Day 180) ]

5.  Secondary:   Number of Subjects With Related Medically-attended Adverse Events (MAEs)   [ Time Frame: From the beginning of the study until study end (from Day 0 to Day 180) . ]

6.  Secondary:   Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)   [ Time Frame: From the beginning of the study until study end (from Day 0 to Day 180) . ]

7.  Secondary:   Number of Subjects With Any and Related Serious Adverse Events (SAEs)   [ Time Frame: From the beginning of the study until study end (from Day 0 to Day 180) ]

8.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata   [ Time Frame: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination. ]

9.  Secondary:   Number of Seroprotected Subjects Against 4 Strains of Influenza Disease   [ Time Frame: At Day 0 (D0) and at Day 21 (D21) after vaccination. ]

10.  Secondary:   Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata   [ Time Frame: At Day 0 (D0) and at Day 21 (D21) after vaccination. ]

11.  Secondary:   Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata   [ Time Frame: At Day 0 (D0) and at Day 21 (D21) after vaccination ]

12.  Secondary:   Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata   [ Time Frame: At Day 21 (D21) after vaccination. ]

13.  Secondary:   Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata   [ Time Frame: At Day 21 (D21) after vaccination ]

14.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata   [ Time Frame: At Day 0 (D0) and at Day 21 (D21) post vaccination. ]

15.  Secondary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease   [ Time Frame: At Day 0 (D0), and at Day 21 (D21) and Day 180 (D180) post vaccination. ]

16.  Secondary:   Number of Seroconverted Subjects Against 4 Strains of Influenza   [ Time Frame: At Day 21 (D21) after vaccination. ]

17.  Secondary:   Number of Seroconverted Subjects Against 4 Strains of Influenza by Age Strata   [ Time Frame: At Day 21 (D21) after vaccination. ]

18.  Secondary:   Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata   [ Time Frame: At Day 21 (D21) post vaccination. ]

19.  Secondary:   Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease   [ Time Frame: At Day 21 (D21) post vaccination. ]

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

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

22.  Secondary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: Within the 21-day (Days 0-20) follow-up period after vaccination ]

23.  Secondary:   Number of Days With Solicited Local Symptoms After Vaccination.   [ Time Frame: Within the 7-day follow-up period after vaccination (Days 0-6) ]

24.  Secondary:   Number of Days With Solicited General Symptoms After Vaccination   [ Time Frame: Within the 7-day follow-up period after vaccination (Days 0-6) ]

25.  Secondary:   Number of Days With Unsolicited Adverse Events (AEs) After Vaccination   [ Time Frame: Within the 21-day (Days 0-20) follow-up period post 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
Analyses of duration for solicited local and general and unsolicited adverse events were not performed. Relationship to vaccination was not computed for medically-attended adverse events. Joint pain data were collected in Canada and Mexico only.


  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: NCT01196975     History of Changes
Other Study ID Numbers: 112963
Study First Received: September 7, 2010
Results First Received: November 21, 2012
Last Updated: November 21, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada