Clinical trial NCT00603252: Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults
Official title: Evaluate the Effect of Risk Factors That Influence the Immunogenicity of GSK Biologicals' Twinrix Compared to Hepatitis A and Hepatitis B Vaccines Given Separately and to Show the Non-inferiority Between the Vaccines in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Hepatitis A
Keywords: combined hepatitis A and B vaccine
risk factors
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 213
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anti-HAV immune response to the challenge dose
measure: Anti-HBs antibody response to the challenge dose
Secondary outcomes:
measure: Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects
timeFrame: Two weeks and one month after the challenge dose
measure: 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
timeFrame: Two weeks and one month after the challenge dose
measure: Occurrence and intensity of solicited local symptoms
timeFrame: In the 4-day follow-up period after the challenge dose
measure: Occurrence, intensity and relationship of solicited general symptoms
timeFrame: In the 4-day follow-up period after the challenge dose
measure: Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported
timeFrame: During the 31-day follow-up period after the challenge dose
measure: Occurrence of all serious adverse events (SAEs) reported
timeFrame: Following the administration of the challenge dose
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
city: Finsterwalde
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Geringswalde
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Pirna
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bad Bramstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Bad Segeberg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Elmshorn
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Chlibek R, von Sonnenburg F, Van Damme P, Smetana J, Tichy P, Gunapalaiah B, Leyssen M, Jacquet JM. Antibody persistence and immune memory 4 years post-vaccination with combined hepatitis A and B vaccine in adults aged over 40 years. J Travel Med. 2011 Mar-Apr;18(2):145-8. doi: 10.1111/j.1708-8305.2010.00499.x. Epub 2011 Feb 7.