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Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506350
First Posted: July 25, 2007
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: September 11, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses

  Participant Flow
  Hide Participant Flow

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
GSK1562902A Non-AD F1 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
GSK1562902A Non-AD F2 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A Non-AD F3 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A Non-AD F4 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Control Group Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A AD F1 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A AD F2 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A AD F3 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A AD Approved F Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.

Participant Flow:   Overall Study
    GSK1562902A Non-AD F1 Primed Group   GSK1562902A Non-AD F2 Primed Group   GSK1562902A Non-AD F3 Primed Group   GSK1562902A Non-AD F4 Primed Group   Control Group   GSK1562902A AD F1 Primed Group   GSK1562902A AD F2 Primed Group   GSK1562902A AD F3 Primed Group   GSK1562902A AD Approved F Primed Group
STARTED   36   40   37   36   50   40   35   41   35 
COMPLETED   33   37   31   34   40   38   33   36   30 
NOT COMPLETED   3   3   6   2   10   2   2   5   5 
Serious Adverse Event                1                0                0                0                0                0                0                0                0 
Adverse Event                0                0                0                0                0                0                0                1                1 
Protocol Violation                0                0                1                0                0                0                1                0                0 
Withdrawal by Subject                0                1                1                1                4                1                1                2                0 
Lost to Follow-up                1                1                1                1                2                1                0                0                2 
Medical Reason                0                0                0                0                1                0                0                0                0 
Not specified                1                1                3                0                3                0                0                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
GSK1562902A Non-AD F1 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 1 (F1) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated intramuscularly (IM) in the deltoid region of the non-dominant arm.
GSK1562902A Non-AD F2 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A Non-AD F3 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A Non-AD F4 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of a non-adjuvanted (non-AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 4 (F4) in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
Control Group Healthy male or female adults, between and including 19 to 61 years of age, unprimed receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A AD F1 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation1 (F1) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A AD F2 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 2 (F2) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A AD F3 Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of an adjuvanted (AD) investigational H5N1 vaccine (A/Vietnam/1194/04 strain) Formulation 3 (F3)in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
GSK1562902A AD Approved F Primed Group Healthy male or female adults, between and including 19 to 61 years of age, primed with 2 doses of approved Formulation (F) of adjuvanted (AD) H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0, administrated IM in the deltoid region of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
   GSK1562902A Non-AD F1 Primed Group   GSK1562902A Non-AD F2 Primed Group   GSK1562902A Non-AD F3 Primed Group   GSK1562902A Non-AD F4 Primed Group   Control Group   GSK1562902A AD F1 Primed Group   GSK1562902A AD F2 Primed Group   GSK1562902A AD F3 Primed Group   GSK1562902A AD Approved F Primed Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   40   37   36   50   40   35   41   35   350 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.3  (12.80)   36.3  (12.36)   36.8  (12.87)   39.5  (13.27)   32.1  (9.96)   38.5  (13.43)   38.3  (14.61)   34.8  (14.57)   35.9  (12.78)   36.32  (12.97) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                   
Female      18  50.0%      19  47.5%      16  43.2%      21  58.3%      34  68.0%      27  67.5%      18  51.4%      23  56.1%      18  51.4%      194  55.4% 
Male      18  50.0%      21  52.5%      21  56.8%      15  41.7%      16  32.0%      13  32.5%      17  48.6%      18  43.9%      17  48.6%      156  44.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
                   
Race                     
White - Arabic / North African heritage      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   2.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   0.3% 
White - Caucasian / European heritage      36 100.0%      38  95.0%      37 100.0%      36 100.0%      48  96.0%      40 100.0%      34  97.1%      41 100.0%      35 100.0%      345  98.6% 
Other      0   0.0%      2   5.0%      0   0.0%      0   0.0%      1   2.0%      0   0.0%      1   2.9%      0   0.0%      0   0.0%      4   1.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Day 0 ]

2.  Primary:   Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Day 21 ]

3.  Primary:   Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Day 21 ]

4.  Primary:   Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Day 21 ]

5.  Primary:   Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Day 0 ]

6.  Primary:   Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Day 21 ]

7.  Primary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

8.  Primary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]

9.  Primary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination ]

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

11.  Primary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (From Day 0 up to Month 24) ]

12.  Secondary:   Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Strain   [ Time Frame: At Days 0, 21 (post-vaccination one) and 42 (post-vaccination two) ]

13.  Secondary:   Titers for Serum Neutralizing HI Antibodies Against A/Indonesia/05/2005 Stain   [ Time Frame: At Months 6, 12, 18 and 24 ]

14.  Secondary:   Titers for Serum H5N1 Haemaglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Days 0, 7, 14, 21, 28, 35 and 42 ]

15.  Secondary:   Titers for Serum H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Months 6, 12, 18 and 24 ]

16.  Secondary:   Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Days 7,14, 21, 35 and 42 ]

17.  Secondary:   Number of Seroconverted (SCR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Months 6, 12, 18 and 24 ]

18.  Secondary:   Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Days 21 (post-vaccination one) and 42 (post-vaccination two) ]

19.  Secondary:   Number of Seroconverted (SCR) Subjects for Neutralizing HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Months 6, 12, 18 and 24 ]

20.  Secondary:   Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Days 7, 14, 21, 35 and 42 ]

21.  Secondary:   Seroconversion Factor (SCF) for H5N1 Haemagglutinin-inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Months 6, 12, 18 and 24 ]

22.  Secondary:   Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Days 0, 7, 14, 21, 28, 35 and 42 ]

23.  Secondary:   Number of Seroprotected (SPR) Subjects for HI Antibodies Against the A/Indonesia/05/2005 Strain   [ Time Frame: At Months 6, 12, 18 and 24 ]

24.  Secondary:   Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines   [ Time Frame: At Days 0 and 21 ]

25.  Secondary:   Frequency of Antigen-specific CD4/CD8 T-cells (Per 10E6) in Tests Identified as Producing at Least Two Out of Four Different Cytokines   [ Time Frame: At Months 6, 12, 18 and 24 ]


  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: NCT00506350     History of Changes
Other Study ID Numbers: 109817
First Submitted: July 24, 2007
First Posted: July 25, 2007
Results First Submitted: September 11, 2017
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017