Phase 3 N=37 Randomized Prevention

Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults

Hepatitis B · Hepatitis A

Bottom Line

View on ClinicalTrials.gov: NCT00289770 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2011

Primary outcome: Primary: Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentrations Equal to or Above Cut-off Value — 25; 28; 23; 24 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Twinrix™ (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Dec 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Anti-hepatitis A (Anti-HAV) Antibody Concentrations Equal to or Above Cut-off Value	25; 28; 23; 24; 31	—
PRIMARY Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values	23; 25; 20; 21; 21; 28	—
PRIMARY Anti-HAV and Anti-HBs Antibody Concentrations	680.3; 602.7; 601.5; 524.7; 610.7; 458.9	—
PRIMARY Anti-HBs Antibody Concentrations	3.29; 3.29; 3.29; 14.5; 6548.1; 554.0	—
PRIMARY Number of Subjects, Receiving an Additional Vaccination of Engerix, With an Anamnestic Response	2	—
PRIMARY Number of Subjects With Solicited Local and General Symptoms Assessed	0; 0; 0; 1; 0; 1	—
PRIMARY Number of Subjects With Unsolicited Symptoms	1	—
PRIMARY Number of Subjects With Serious Adverse Events (SAEs)	—	—
PRIMARY Number of Subjects With Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy	0; 0; 0; 0; 0	—

Summary

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. This protocol posting deals with objectives & outcome measures of the extension phase at Year 11-15.

Eligibility Criteria

Inclusion Criteria

Subjects who had consented to participate in the long-term follow-up studies at the previous long-term blood sampling time points
Written informed consent will have been obtained from each subject. before the blood sampling visit of each year.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00289770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.