Overview

This trial is active, not recruiting.

Condition hepatitis a
Treatment havrix™
Phase phase 3
Sponsor GlaxoSmithKline
Start date January 2004
End date February 2004
Trial size 78 participants
Trial identifier NCT00289757, 100576 (Y11), 100577 (Y12), 100578 (Y13), 100579 (Y14), 100580 (Y15), 111028 (Y16), 111029 (Y17), 111030 (Y18), 111031 (Y19), 111032 (Y20)

Summary

The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study. As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up.
havrix™
2 doses at 6 months interval

Primary Outcomes

Measure
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
time frame: At Years 11, 12, 13, 14, 15, 16, 17, 18 and 19 after the first vaccine dose of the 2-dose primary vaccination
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
time frame: Before the additional dose, 14 days and 30 days after the additional dose
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
time frame: At Year 20 after the first vaccine dose of the 2-dose primary vaccination
Number of Seropositive Subjects for Anti-HAV Antibodies.
time frame: From Year 11 to Year 19
Number of Seropositive Subjects for Anti-HAV Antibodies.
time frame: At Year 20

Secondary Outcomes

Measure
Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy
time frame: Years 11, 12, 13, 14, 15, 16, 17, 18 and 19 after the first vaccine dose of the 2-dose primary vaccination
Occurrence of Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy
time frame: Years 20 after the first vaccine dose of the 2-dose primary vaccination
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
time frame: During the 4-day (Day 0-3) follow-up period after additional vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
time frame: During the 4-day (Day 0-3) follow-up period after additional vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AE)
time frame: During the 30-day follow-up period after additional vaccination (for subjects who received the additional vaccine dose between Year 11 and 15)
Number of Subjects Reporting Serious Adverse Events (SAE)
time frame: During the follow-up period after additional vaccination up to Year 19
Number of Subjects Reporting Serious Adverse Events (SAE)
time frame: During the follow-up period after additional vaccination up to Year 20

Eligibility Criteria

Male or female participants from 29 years up to 60 years old.

Inclusion Criteria: - Subjects who had received at least one dose of the study vaccine in the primary study - Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

Additional Information

Official title Long Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per ml and Injected According to a 0, 6-month Schedule in Healthy Adult Subjects
Description This is a long-term follow-up study at Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will donate a blood sample at Years 11, 12, 13, 14,15, 16, 17, 18, 19 and 20 after the first vaccine dose of the primary vaccination course to determine their anti-hepatitis A (anti-HAV) antibody concentrations If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Years 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination, 14 days and one month after additional vaccination to evaluate the immune response following this vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 and to include an extended follow up period up to Year 20 after primary vaccination. The study has 10 phases (100576, 100577, 100578, 100579, 100580, 111028, 111029, 111030, 111031, 111032).
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.