Last updated: 11/06/2018 23:25:14

Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule

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GSK study ID

100571 (M138)

See study documents

Clinicaltrials.gov ID

NCT00291876

See results summary

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Completed

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers

Trial description: The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174,186, 198, 210, 222, 234 and 246 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 20.

No additional subjects will be recruited during this long-term follow-up.

Primary purpose:

Prevention

Trial design:

Single Group Assignment

Masking:

None (Open Label)

Allocation:

Not applicable

Primary outcomes:

Anti-hepatitis A virus (anti-HAV) antibody concentration

Timeframe: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Number of seropositive subjects against hepatitis A virus

Timeframe: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Secondary outcomes:

Anti-hepatitis A virus (anti-HAV) antibody concentration

Timeframe: Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination

Number of subjects reporting solicited local symptoms

Timeframe: During the 4-day (Days 0-3) follow-up period after additional vaccination

Number of subjects reporting solicited general symptoms

Timeframe: During the 4-day (Days 0-3) follow-up period after additional vaccination

Number of subjects reporting unsolicited adverse events (AE)

Timeframe: During the 30-day follow-up period after additional vaccination

Number of subjects reporting serious adverse events (SAE) assessed by the investigator as related to primary study vaccination, procedures or lack of vaccine efficacy

Timeframe: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Number of subjects reporting Serious Adverse Events (SAE) after additional vaccination

Timeframe: During the 30-day follow-up period after additional vaccination

Number of subjects reporting pregnancies after additional vaccination

Timeframe: At Months 186 and 198

Interventions:

Biological/vaccine: Havrix™

Enrollment:

135

Observational study model:

Not applicable

Primary completion date:

2004-15-03

Time perspective:

Not applicable

Clinical publications:

Van Herck K et al. (2011) Antibody persistence and immune memory in healthy adults following vaccination with a two-dose inactivated hepatitis A vaccine: long-term follow-up at 15 years. J Med Virol. 83(11):1885-1891.

Van Herck K et al. (2012) Seventeen-year antibody persistence in adults primed with two doses of an inactivated hepatitis A vaccine. Hum Vaccin Immunother. 8(3) [Epub ahead of print].

Medical condition

Hepatitis A

Product

SB208109

Collaborators

Not applicable

Study date(s)

January 2004 to March 2004

Type

Interventional

Phase

Participation criteria

Sex

Female & Male

Age

29 - 60 years

Accepts healthy volunteers

Yes

Inclusion Criteria:
Subjects who had received at least one dose of the study vaccine in the primary study

Trial location(s)

Location

Status

Location

GSK Investigational Site

Wilrijk, Belgium, 2610

Status

Study Complete

Study documents

Clinical study report

Available language(s): English

Download document(s)

Scientific result summary

Available language(s): English

Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status

Completed

Actual primary completion date

2004-15-03

Actual study completion date

2004-15-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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