Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343915
First received: September 14, 2005
Last updated: September 29, 2016
Last verified: September 2016
Results First Received: December 23, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Hepatitis B
Interventions: Biological: Engerix™-B (thiomersal-free) 20µg
Biological: 10 μg Engerix™-B (preservative-free)
Biological: placebo

  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

All subjects who participated in the primary vaccination study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up were contacted by the investigators.

No additional subjects were recruited during this long-term follow-up study.


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
2-dose Engerix subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
3-dose Engerix subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.

Participant Flow for 5 periods

Period 1:   Primary Study
    2-dose Engerix   3-dose Engerix
STARTED   258   126 
COMPLETED   254   123 
NOT COMPLETED   4   3 
Withdrawal by Subject                1                0 
Lost to Follow-up                2                3 
Unspecified                1                0 

Period 2:   Month 30 Follow-up
    2-dose Engerix   3-dose Engerix
STARTED   179 [1]   88 
COMPLETED   179   88 
NOT COMPLETED   0   0 
[1] Subjects, previously vaccinated, that returned for the Month 30 follow-up.

Period 3:   Month 42 Follow-up
    2-dose Engerix   3-dose Engerix
STARTED   174 [1]   84 
COMPLETED   174   84 
NOT COMPLETED   0   0 
[1] Subjects, previously vaccinated, that returned for the Month 42 follow-up.

Period 4:   Month 54 Follow-up
    2-dose Engerix   3-dose Engerix
STARTED   166 [1]   79 
COMPLETED   166   79 
NOT COMPLETED   0   0 
[1] Subjects, previously vaccinated, that returned for the Month 54 follow-up.

Period 5:   Month 66 Follow-up
    2-dose Engerix   3-dose Engerix
STARTED   158 [1]   76 
COMPLETED   158   76 
NOT COMPLETED   0   0 
[1] Subjects, previously vaccinated, that returned for the Month 66 follow-up.



  Baseline Characteristics
  Hide Baseline Characteristics

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
2-dose Engerix subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
3-dose Engerix subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Total Total of all reporting groups

Baseline Measures
   2-dose Engerix   3-dose Engerix   Total 
Overall Participants Analyzed 
[Units: Participants]
 258   126   384 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.9  (1.23)   12.7  (1.32)   12.8  (1.26) 
Gender 
[Units: Participants]
     
Female   132   61   193 
Male   126   65   191 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.   [ Time Frame: At Month 7 ]

2.  Primary:   Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.   [ Time Frame: At Month 30, Month 42, Month 54 and Month 66 ]

3.  Primary:   Antibody Titers Against Hepatitis-B Virus.   [ Time Frame: At Month 30, Month 42, Month 54 and Month 66 ]

4.  Secondary:   Antibody Titers Against Hepatitis-B Virus.   [ Time Frame: At Months 1, 2, 6 and 7 ]

5.  Secondary:   Number of Subjects Seroprotected for Anti-HBs Antibody.   [ Time Frame: At Months 1, 2 and 6 ]

6.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 4-day (Day 0-3) follow-up period after each vaccination and overall ]

7.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.   [ Time Frame: During the 4-day (Day 0-3) follow-up period after each vaccination and overall ]

8.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).   [ Time Frame: During the 31-day (Day 0-30) follow-up period after each vaccination and overall ]

9.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (Month 0 to Month 66) ]

10.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs).   [ Time Frame: At Month 30, Month 42, Month 54 & Month 66 ]


  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
  Hide More Information

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:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00343915     History of Changes
Obsolete Identifiers: NCT00787228
Other Study ID Numbers: 101695 Ext. Mth30
101696 ( Other Identifier: GSK )
101697 ( Other Identifier: GSK )
101698 ( Other Identifier: GSK )
Study First Received: September 14, 2005
Results First Received: December 23, 2008
Last Updated: September 29, 2016
Health Authority: Australia: Human Research Ethics Committee