Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults

Phase 4

Completed

• Conditions: Hepatitis B; Hepatitis A

• Registration Number: NCT00603252
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This protocol posting describes the booster phase of the study. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).

Detailed Description

All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-28
• Study First Posted: 2008-01-29
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• A male or female who completed the primary vaccination phase of the study.
• Written informed consent obtained from the subject.
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrolment.
• Pregnant or lactating female.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anti-HAV immune response to the challenge dose
Anti-HBs antibody response to the challenge dose

Secondary Outcome Measures

Name	Time	Method
Occurrence of all serious adverse events (SAEs) reported	Following the administration of the challenge dose
Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects	Two weeks and one month after the challenge dose
Percentage of subjects with anti-HBs antibody titres ≥ 3.3 mIU/ml, ≥ 10 mIU/ml, ≥ 100 mIU/ml and anti-HBs GMTs calculated on seropositive subjects	Two weeks and one month after the challenge dose
Occurrence and intensity of solicited local symptoms	In the 4-day follow-up period after the challenge dose
Occurrence, intensity and relationship of solicited general symptoms	In the 4-day follow-up period after the challenge dose
Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported	During the 31-day follow-up period after the challenge dose

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Elmshorn, Schleswig-Holstein, Germany