Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00510874
First received: August 1, 2007
Last updated: December 19, 2013
Last verified: December 2013
Results First Received: December 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Pumarix™
Biological: Pandemrix ™

  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
No text entered.

Reporting Groups
  Description
Pumarix Formulation 1 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pandemrix Formulation A Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pandemrix Formulation B Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 5 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).

Participant Flow:   Overall Study
    Pumarix Formulation 1 Group     Pumarix Formulation 2 Group     Pumarix Formulation 3 Group     Pandemrix Formulation A Group     Pandemrix Formulation B Group     Pumarix Formulation 4 Group     Pumarix Formulation 5 Group  
STARTED     78     152     151     151     148     50     50  
COMPLETED     75 [1]   148 [1]   150 [1]   148 [1]   141 [1]   50 [1]   49 [1]
NOT COMPLETED     3     4     1     3     7     0     1  
Withdrawal by Subject                 1                 1                 0                 0                 3                 0                 0  
Lost to Follow-up                 2                 3                 1                 3                 4                 0                 1  
[1] Upto Day 182



  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
Pumarix Formulation 1 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pandemrix Formulation A Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pandemrix Formulation B Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Pumarix Formulation 5 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Total Total of all reporting groups

Baseline Measures
    Pumarix Formulation 1 Group     Pumarix Formulation 2 Group     Pumarix Formulation 3 Group     Pandemrix Formulation A Group     Pandemrix Formulation B Group     Pumarix Formulation 4 Group     Pumarix Formulation 5 Group     Total  
Number of Participants  
[units: participants]
  78     152     151     151     148     50     50     780  
Age  
[units: Years]
Mean ± Standard Deviation
  38.5  ± 12.85     38.1  ± 12.10     39.0  ± 12.59     38.7  ± 11.25     38.7  ± 12.20     39.2  ± 12.21     39.9  ± 13.18     38.8  ± 12.22  
Gender  
[units: Subjects]
               
Female     45     83     87     100     78     32     24     449  
Male     33     69     64     51     70     18     26     331  



  Outcome Measures
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1.  Primary:   Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.   [ Time Frame: At Day 42 ]

2.  Primary:   Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.   [ Time Frame: At Day 42 ]

3.  Primary:   Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.   [ Time Frame: At Day 42 ]

4.  Primary:   Number of Subjects With Solicited Local Symptoms.   [ Time Frame: Within the 7-day follow-up period (Days 0-6) after any vaccination ]

5.  Primary:   Number of Subjects With Solicited General Symptoms.   [ Time Frame: Within the 7-day follow-up period (Days 0-6) after any vaccination ]

6.  Primary:   Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).   [ Time Frame: From Day 0 to 182 ]

7.  Primary:   Number of Subjects With Unsolicited Adverse Events (AEs).   [ Time Frame: During the 21-day follow-up period (Days 0-20) after vaccination. ]

8.  Primary:   Number of Subjects With Unsolicited Adverse Events (AEs).   [ Time Frame: Between Day 0 and Day 84 after vaccination. ]

9.  Primary:   Number of Subjects With Any Serious Adverse Events (SAEs).   [ Time Frame: From Day 0 to 182 ]

10.  Secondary:   Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.   [ Time Frame: At Day 21 and Day 182 ]

11.  Secondary:   Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.   [ Time Frame: At Days 21 and 182 ]

12.  Secondary:   Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.   [ Time Frame: At Days 21 and 182 ]

13.  Secondary:   Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.   [ Time Frame: At Days 0, 21 and 182 ]


  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


Publications:
Langley J et al. Safety and cross-reactive immunogenicity of two H5N1 A/Indonesia/5/2005 (clade 2.1) AS03-adjuvanted prepandemic candidate influenza vaccines. A phase I/II clinical trial. Abstract presented at the Third European Influenza Conference, Vilamoura, Portugal, 14-17 September 2008.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00510874     History of Changes
Other Study ID Numbers: 110028
Study First Received: August 1, 2007
Results First Received: December 19, 2013
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration