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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Hepatitis A

Hepatitis B

Treatments

Biological: Vaqta

Biological: HBVAXPRO

Biological: Havrix

Biological: Engerix-B

Biological: Twinrix

Study type

Interventional

Funder types

Industry

Identifiers

NCT00603252

111149

Details and patient eligibility

About

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).

Full 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.

Enrollment

213 patients

Sex

All

Ages

41+ years old

Volunteers

Accepts Healthy Volunteers

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.