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: October 2, 2014
Last verified: November 2011
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
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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

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 4 periods

Period 1:   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 2:   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 3:   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 4:   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
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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
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  
Number of Participants  
[units: participants]
  179     88     267  
Age  
[units: years]
Mean ± Standard Deviation
  15.6  ± 1.34     15.4  ± 1.59     15.5  ± 1.43  
Gender  
[units: participants]
     
Female     92     44     136  
Male     87     44     131  



  Outcome Measures
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1.  Primary:   Number of Anti-hepatitis B Surface Antigen (Anti-HBs) Seroprotected Subjects   [ Time Frame: At Months 30, 42, 54 & 66 ]

2.  Secondary:   Occurrence of Serious Adverse Events Determined by the Investigators to Have a Causal Relationship to Vaccination or to Study Procedures   [ Time Frame: At Months 30, 42, 54 & 66 ]


  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:
Heron LG et al. A novel hepatitis B vaccination regimen for adolescents - 2 doses 12 months apart. Abstract presented at the 10th ICID Singapore, Bangkok, March 2002.
Heron L et al. Randomised control trial: 2-vs 3-dose hepatitis B immunization of adolescents. Abstract presented at the 12th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD), Paris, France, 1-5 July 2006.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00343915     History of Changes
Obsolete Identifiers: NCT00787228
Other Study ID Numbers: 101695 Ext. Mth30, 101696, 101697, 101698
Study First Received: September 14, 2005
Results First Received: December 23, 2008
Last Updated: October 2, 2014
Health Authority: Australia: Human Research Ethics Committee