Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01730378
First received: November 15, 2012
Last updated: August 3, 2015
Last verified: August 2015
Results First Received: December 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Prepandrix™
Biological: Fluarix™

  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
Prepandrix Group Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.

Participant Flow:   Overall Study
    Prepandrix Group     Fluarix Group  
STARTED     84     47  
COMPLETED     83     47  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 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.
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Reporting Groups
  Description
Prepandrix Group Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Total Total of all reporting groups

Baseline Measures
    Prepandrix Group     Fluarix Group     Total  
Number of Participants  
[units: participants]
  84     47     131  
Age  
[units: Years]
Mean (Standard Deviation)
  39.3  (10.94)     40.4  (10.3)     39.69  (10.69)  
Gender  
[units: Participants]
     
Female     61     34     95  
Male     23     13     36  



  Outcome Measures
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1.  Primary:   Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.   [ Time Frame: At Day 42 ]

2.  Primary:   Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.   [ Time Frame: At Day 42 ]

3.  Primary:   Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.   [ Time Frame: At Day 42 ]

4.  Primary:   Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.   [ Time Frame: At Day 0 and Day 42 ]

5.  Secondary:   Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.   [ Time Frame: At Day 21 ]

6.  Secondary:   Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.   [ Time Frame: At Day 0 and Day 21 ]

7.  Secondary:   Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.   [ Time Frame: At Day 21 ]

8.  Secondary:   Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.   [ Time Frame: At Day 21 ]

9.  Secondary:   Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.   [ Time Frame: At Days 0 and 21 ]

10.  Secondary:   Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.   [ Time Frame: At Day 21 ]

11.  Secondary:   Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.   [ Time Frame: At Day 21 ]

12.  Secondary:   Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.   [ Time Frame: At Day 0 and Day 21 ]

13.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.   [ Time Frame: During the 7-day (Day 0-6) period after each vaccination ]

14.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]

15.  Secondary:   Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).   [ Time Frame: During the entire study period (From Day 0 to Day 182) ]

16.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs)   [ Time Frame: During the 21 days (Day 0-20) post-vaccination period ]

17.  Secondary:   Number of Subjects Reporting Unsolicted AEs   [ Time Frame: During the 84-day (Days 0-83) post vaccination period ]

18.  Secondary:   Number of Subjects Any Unsolicited AEs   [ Time Frame: During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group ]

19.  Secondary:   Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (From Day 0 to 182) ]


  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: NCT01730378     History of Changes
Other Study ID Numbers: 114695
Study First Received: November 15, 2012
Results First Received: December 15, 2014
Last Updated: August 3, 2015
Health Authority: Korea: Korea Food & Drug Administration