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Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01014091
First Posted: November 16, 2009
Last Update Posted: May 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: March 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: GSK pandemic vaccine GSK2340272A

  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
From a total of 60 subjects enrolled in the study only 58 were vaccinated.

Reporting Groups
  Description
GSK2340272A F1 Y3-5 Group Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F1 Y6-9 Group Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F2 Y3-5 Group Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F2 Y6-9 Group Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F3 Y3-5 Group Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F3 Y6-9 Group Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

Participant Flow:   Overall Study
    GSK2340272A F1 Y3-5 Group   GSK2340272A F1 Y6-9 Group   GSK2340272A F2 Y3-5 Group   GSK2340272A F2 Y6-9 Group   GSK2340272A F3 Y3-5 Group   GSK2340272A F3 Y6-9 Group
STARTED   7   13   5   15   6   12 
COMPLETED   7   13   5   15   6   12 
NOT COMPLETED   0   0   0   0   0   0 



  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
GSK2340272A F1 Y3-5 Group Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F1 Y6-9 Group Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F2 Y3-5 Group Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F2 Y6-9 Group Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F3 Y3-5 Group Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
GSK2340272A F3 Y6-9 Group Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
Total Total of all reporting groups

Baseline Measures
   GSK2340272A F1 Y3-5 Group   GSK2340272A F1 Y6-9 Group   GSK2340272A F2 Y3-5 Group   GSK2340272A F2 Y6-9 Group   GSK2340272A F3 Y3-5 Group   GSK2340272A F3 Y6-9 Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   13   5   15   6   12   58 
Age 
[Units: Years]
Mean (Standard Deviation)
 4.1  (0.9)   7.5  (1.2)   3.8  (0.84)   7.3  (0.9)   3.8  (0.98)   7.6  (0.9)   6.36  (1.90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      3  42.9%      7  53.8%      2  40.0%      4  26.7%      1  16.7%      3  25.0%      20  34.5% 
Male      4  57.1%      6  46.2%      3  60.0%      11  73.3%      5  83.3%      9  75.0%      38  65.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Haemagglutination Inhibition (HI) Antibody Titers Against Vaccine H1N1 Antigen   [ Time Frame: At Day 42 ]

2.  Primary:   Number of Seropositive Subjects for HI Antibodies   [ Time Frame: At Day 42 ]

3.  Primary:   Number of Seroconverted Subjects in Terms of HI Antibodies   [ Time Frame: At Day 42 ]

4.  Primary:   Number of Seroprotected Subjects for HI Antibodies   [ Time Frame: At Day 42 ]

5.  Primary:   Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer   [ Time Frame: At Day 42 ]

6.  Secondary:   Number of Seropositive Subjects for HI Antibodies   [ Time Frame: At Day 0, Day 21 and Month 7 ]

7.  Secondary:   HI Antibody Titers Against Vaccine H1N1 Antigen   [ Time Frame: At Day 0, Day 21 and Month 7 ]

8.  Secondary:   Number of Seroconverted Subjects in Terms of HI Antibodies   [ Time Frame: At Day 21 and Month 7 ]

9.  Secondary:   Number of Seroprotected Subjects for HI Antibodies   [ Time Frame: At Day 0, Day 21 and Month 7 ]

10.  Secondary:   Geometric Mean Fold Increase (GMFR) for Serum HI Antibody Titer   [ Time Frame: At Day 21 and Month 7 ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]

14.  Secondary:   Number of Subjects With Any Medically-attended Events (MAEs)   [ Time Frame: During the entire study period (from Month 0 up to Month 12) ]

15.  Secondary:   Number of Subjects With Adverse Events of Specific Interest (AESIs)/Potential Immune-mediated Disease (pIMDs)   [ Time Frame: During the entire study period (from Month 0 up to Month 12) ]

16.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: Within the 42-day (Days 0-41) post-vaccination period ]

17.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Month 0 to Month 12) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  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: NCT01014091     History of Changes
Other Study ID Numbers: 113810
First Submitted: November 12, 2009
First Posted: November 16, 2009
Results First Submitted: March 7, 2017
Results First Posted: May 4, 2017
Last Update Posted: May 4, 2017