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Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00719043
First received: July 18, 2008
Last updated: May 22, 2014
Last verified: May 2014
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: A/turkey H5N1 vaccine
Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)
Biological: Placebo

  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
Study duration was of approximately 909 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
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.

Participant Flow:   Overall Study
    A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group     A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group     A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group     A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group     A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group     A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group     Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group  
STARTED     120     121     119     119     122     120     120  
COMPLETED     88 [1]   96 [1]   99 [1]   96 [1]   95 [1]   86 [1]   92 [1]
NOT COMPLETED     32     25     20     23     27     34     28  
Adverse Event                 5                 1                 2                 2                 1                 4                 4  
Lost to Follow-up                 14                 10                 8                 9                 10                 9                 9  
Protocol Violation                 0                 0                 0                 0                 0                 1                 0  
Unspecified                 1                 0                 1                 2                 0                 2                 1  
Withdrawal by Subject                 12                 14                 9                 10                 16                 18                 14  
[1] Up to Day 909



  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
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Total Total of all reporting groups

Baseline Measures
    A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group     A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group     A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group     A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group     A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group     A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group     Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group     Total  
Number of Participants  
[units: participants]
  120     121     119     119     122     120     120     841  
Age  
[units: Years]
Mean ± Standard Deviation
  49.8  ± 18.01     49.6  ± 17.93     50.7  ± 17.67     49.2  ± 17.75     50.3  ± 17.77     50.1  ± 18.92     50.0  ± 18.03     49.95  ± 17.99  
Gender  
[units: Subjects]
               
Female     80     73     69     70     68     70     75     505  
Male     40     48     50     49     54     50     45     336  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.   [ Time Frame: At Day 559 ]

2.  Primary:   Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.   [ Time Frame: At Day 192 ]

3.  Primary:   Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.   [ Time Frame: At Days 549 and 559 ]

4.  Primary:   Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.   [ Time Frame: At Days 182 and 192 ]

5.  Primary:   Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.   [ Time Frame: At Days 549 and 559 ]

6.  Primary:   Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.   [ Time Frame: At Days 182 and 192 ]

7.  Primary:   Number of Subjects With Solicited Local Symptoms   [ Time Frame: Within the 7-day (Days 0-6) post vaccination periods ]

8.  Primary:   Number of Subjects With Solicited General Symptoms   [ Time Frame: Within the 7-day (Days 0-6) post vaccination periods ]

9.  Primary:   Number of Subjects With Medically-attended Adverse Events (MAEs)   [ Time Frame: From Day 0 to Day 909 ]

10.  Primary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: Within the 43-day (Days 0-42) post-vaccination periods ]

11.  Primary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: From Day 0 to Day 909 ]

12.  Secondary:   Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.   [ Time Frame: At Day 192 ]

13.  Secondary:   Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.   [ Time Frame: At Days 182 and 192 ]

14.  Secondary:   Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.   [ Time Frame: At Days 182 and 192 ]

15.  Secondary:   Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.   [ Time Frame: At Day 591 ]

16.  Secondary:   Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.   [ Time Frame: At Day 224 ]

17.  Secondary:   Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain   [ Time Frame: At Days 192 and 224 ]

18.  Secondary:   Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain   [ Time Frame: At Day 559 ]

19.  Secondary:   Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.   [ Time Frame: At Day 591 ]

20.  Secondary:   Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.   [ Time Frame: At Day 224 ]

21.  Secondary:   Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.   [ Time Frame: At Days 0, 182,192, 224, 549 and 729 ]

22.  Secondary:   Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.   [ Time Frame: At Days 0, 182, 549, 559, 591 and 729 ]

23.  Secondary:   Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.   [ Time Frame: At Days 0, 182, 192, 224, 549, 559, 591 and 729 ]

24.  Secondary:   Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.   [ Time Frame: At Days 0, 182,192, 224, 549 and 729 ]

25.  Secondary:   Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain   [ Time Frame: At Days 0, 182, 549, 559, 591 and 729 ]

26.  Secondary:   Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain   [ Time Frame: At Days 0, 182, 192, 224, 549, 559, 591 and 729 ]

27.  Secondary:   Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.   [ Time Frame: At Days 0, 10, 42, 182 and 549 ]

28.  Secondary:   Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.   [ Time Frame: At Days 0, 10, 42, 182, 549 and 559 ]

29.  Secondary:   Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.   [ Time Frame: At Day 0, Day 10, Day 42, Day 182 and Day 549 ]

30.  Secondary:   Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.   [ Time Frame: At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559 ]

31.  Secondary:   Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.   [ Time Frame: At Days 10 and 42 ]

32.  Secondary:   Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.   [ Time Frame: At Days 192 and 224 ]


  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: NCT00719043     History of Changes
Other Study ID Numbers: 110624
Study First Received: July 18, 2008
Results First Received: December 19, 2013
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration