Clinical trial NCT00197184: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Hepatitis A
Keywords: Combined hepatitis A and B vaccine
Twinrix™
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 276
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.

Eligibility criteria: Inclusion Criteria:

* Participation in primary study
* Written informed consent obtained before each long term follow up visit.

Primary outcomes:
measure: Anti-hepatitis A (HAV) Antibody Concentrations
timeFrame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
measure: Anti-hepatitis B (HBs) Antibody Concentrations
timeFrame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
measure: Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
timeFrame: Before and one month after additional vaccination
measure: Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
timeFrame: Before and One month after additional vaccination
Secondary outcomes:
measure: 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
measure: Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms
timeFrame: during the 4-day follow-up period after additional vaccination
measure: Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.
timeFrame: During the 4-day follow-up period after additional vaccination
measure: 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.
measure: Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events
timeFrame: At least one month after additional vaccination
Other outcomes:
Locations:
city: North Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Carlton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Blanes (Girona)
country: Spain
facility: GSK Investigational Site
city: Cerdanyola Del Vallés / Barcelona
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Marshall H, Nolan T, Diez Domingo J, Rombo L, Sokal EM, Mares J, Casanovas JM, Kuriyakose S, Leyssen M, Jacquet JM. 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. 2010 Jun 17;28(27):4411-5. doi: 10.1016/j.vaccine.2010.04.040. Epub 2010 Apr 29.