Last updated: 11/07/2018 12:57:07

Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 dosing schedules of the Combined Hepatitis A and B Vaccine were Compared

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GSK study ID
208127/132 (EXT Y2)
See study documents
Clinicaltrials.gov ID
NCT00197184
See results summary
EudraCT ID
2015-001515-12
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 month Schedule and a 0,1,6 month Schedule, in Healthy Children Aged Between 1-11 years at the Time of First Vaccine Dose
Trial description: To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Anti-hepatitis A (HAV) antibody concentrations

Timeframe: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)

Anti-hepatitis B (HBs) antibody concentrations

Timeframe: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)

Anti-HAV antibody concentrations in subjects receiving the additional vaccine dose.

Timeframe: Before and one month after additional vaccination

Anti-HBs antibody concentrations in subjects receiving the additional vaccine dose.

Timeframe: Before and One month after additional vaccination

Secondary outcomes:

Number of subjects reporting Serious Adverse Events (SAEs) determined by the investigator to have a causal relationship to primary vaccination or due to lack of vaccine efficacy.

Timeframe: From last study visit of the primary study up to Year 5 long term follow-up

Number of subjects receiving an additional vaccine dose and reporting solicited local symptoms

Timeframe: during the 4-day follow-up period after additional vaccination

Number of subjects receiving an additional vaccine dose and reporting solicited general symptoms.

Timeframe: During the 4-day follow-up period after additional vaccination

Number of subjects receiving an additional vaccine dose and reporting unsolicited adverse events (AEs).

Timeframe: During the 30-day follow-up period after additional vaccination.

Number of subjects receiving an additional vaccine dose and reporting any Serious Adverse Events

Timeframe: At least one month after additional vaccination

Interventions:
Biological/vaccine: Twinrix™ Adult
Biological/vaccine: Twinrix™ Junior
Enrollment:
276
Observational study model:
Not applicable
Primary completion date:
2004-10-03
Time perspective:
Not applicable
Clinical publications:
Marshall H et al. (2010) Long-term (5-year) antibody persistence following two- and three-dose regimens of a combined hepatitis A and B vaccine in children aged 1–11 years. Vaccine. 28:4411–4415
Medical condition
Hepatitis B
Product
SB208127
Collaborators
Not applicable
Study date(s)
November 2003 to March 2004
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
3 - 13 years
Accepts healthy volunteers
Yes
  • Inclusion Criteria:
  • Participation in primary study
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion Criteria:
  • Participation in primary study
  • Written informed consent obtained before each long term follow up visit.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Valencia, Spain, 46024
Status
Study Complete
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Location
GSK Investigational Site
Blanes (Girona), Spain, 17300
Status
Study Complete
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Location
GSK Investigational Site
Bruxelles, Belgium, 1200
Status
Study Complete
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Location
GSK Investigational Site
Cerdanyola del Vallés / Barcelona, Spain, 08290
Status
Study Complete
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Location
GSK Investigational Site
Barcelona, Spain, 08042
Status
Study Complete
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Location
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Status
Study Complete
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Location
GSK Investigational Site
Carlton, Victoria, Australia, 3053
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2004-10-03
Actual study completion date
2004-10-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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