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Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01001169
First received: October 22, 2009
Last updated: March 22, 2017
Last verified: March 2017
Results First Received: March 14, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)

  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
GSK2340274A_F1 6M-9Y Group Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
GSK2340274A_F2 10Y-17Y Group Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.

Participant Flow:   Overall Study
    GSK2340274A_F1 6M-9Y Group   GSK2340274A_F2 10Y-17Y Group
STARTED   30   30 
COMPLETED   28   29 
NOT COMPLETED   2   1 
Withdrawal by Subject                2                1 



  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
GSK2340274A_F1 6M-9Y Group Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
GSK2340274A_F2 10Y-17Y Group Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
Total Total of all reporting groups

Baseline Measures
   GSK2340274A_F1 6M-9Y Group   GSK2340274A_F2 10Y-17Y Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Months]
Mean (Standard Deviation)
 49.00  (27.66)   163.00  (32.41)   106.00  (64.78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      16  53.3%      18  60.0%      34  56.7% 
Male      14  46.7%      12  40.0%      26  43.3% 


  Outcome Measures
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1.  Primary:   Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Day 42 ]

2.  Primary:   Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease   [ Time Frame: At Day 42 ]

3.  Primary:   Number of Seroconverted Subjects for 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 Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease   [ Time Frame: At Day 42 ]

6.  Secondary:   Number of Subjects With HI Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Days 0 and 21 ]

7.  Secondary:   Number of Subjects With HI Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Days 0 and 42 ]

8.  Secondary:   Number of Subjects With HI Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Days 0 and 182 ]

9.  Secondary:   Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease   [ Time Frame: At Days 0 and 21 ]

10.  Secondary:   Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease   [ Time Frame: At Days 0 and 42 ]

11.  Secondary:   Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease   [ Time Frame: At Days 0 and 182 ]

12.  Secondary:   Number of Seroconverted Subjects for HI Antibodies   [ Time Frame: At Day 21 ]

13.  Secondary:   Number of Seroconverted Subjects for HI Antibodies   [ Time Frame: At Day 42 ]

14.  Secondary:   Number of Seroconverted Subjects for HI Antibodies   [ Time Frame: At Day 182 ]

15.  Secondary:   Number of Seroprotected Subjects for HI Antibodies   [ Time Frame: At Days 0 and 21 ]

16.  Secondary:   Number of Seroprotected Subjects for HI Antibodies   [ Time Frame: At Days 0 and 42 ]

17.  Secondary:   Number of Seroprotected Subjects for HI Antibodies   [ Time Frame: At Days 0 and 182 ]

18.  Secondary:   Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease   [ Time Frame: At Day 21 ]

19.  Secondary:   SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease   [ Time Frame: At Day 42 ]

20.  Secondary:   SCF for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease   [ Time Frame: At Day 182 ]

21.  Secondary:   Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Days 0 and 21 ]

22.  Secondary:   Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Days 0 and 42 ]

23.  Secondary:   Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Days 0 and 182 ]

24.  Secondary:   Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease   [ Time Frame: At Days 0 and 21 ]

25.  Secondary:   Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease   [ Time Frame: At Days 0 and 42 ]

26.  Secondary:   Titers for Serum Neutralizing Antibodies Against Flu A/Neth/602/09 Strain of Influenza Disease   [ Time Frame: At Days 0 and 182 ]

27.  Secondary:   Number of Subjects With Vaccine Response Rates (VRR) for Neutralizing Antibodies Against Flu A/Neth/602/09 H1N1   [ Time Frame: At Day 21 ]

28.  Secondary:   Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1   [ Time Frame: At Day 42 ]

29.  Secondary:   Number of Subjects With Vaccine Response Rates (VRR) for Neutralising Antibodies Against Flu A/Neth/602/09 H1N1   [ Time Frame: At Day 182 ]

30.  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 ]

31.  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 ]

32.  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 ]

33.  Secondary:   Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: Up to 84 days (Days 0-83) after the first vaccination ]

34.  Secondary:   Number of Subjects With Medically Attended Events (MAEs)   [ Time Frame: During the entire study period (from Day 0 to Day 182) ]

35.  Secondary:   Number of Subjects With Potential Immune-Mediated Diseases (pIMDs)   [ Time Frame: During the entire study period (from Day 0 to Day 182) ]

36.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Day 0 to Day 182) ]

37.  Secondary:   Number of Subjects With Normal or Abnormal Biochemical Levels   [ Time Frame: At Days 0, 7 and 42 ]

38.  Secondary:   Number of Subjects With Normal or Abnormal Values of Haematological Parameters   [ Time Frame: At Days 0, 7 and 42 ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01001169     History of Changes
Other Study ID Numbers: 113847
Study First Received: October 22, 2009
Results First Received: March 14, 2017
Last Updated: March 22, 2017