Phase 4 N=78 Randomized Prevention

Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine, Injected According to 0, 6-month Schedule

Hepatitis A

Bottom Line

View on ClinicalTrials.gov: NCT00289757 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2010

Primary outcome: Primary: Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration — 593.6; 297.4; 363.2; 287.7 mIU/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Havrix™ (Biological)
Age: Adult · 29+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration	23; 702; 836; 24; 6107; 5939	—
PRIMARY Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration	23; 702; 836; 24; 6107; 5939	—
PRIMARY Number of Seropositive Subjects for Anti-HAV Antibodies.	43; 46; 42; 50; 46; 41	—
SECONDARY Number of Subjects Reporting Serious Adverse Events (SAE) Assessed by the Investigators as Related to Vaccination or to Study Procedures or Lack of Efficacy	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms	1; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms	0; 0; 0; 0	—
SECONDARY Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AE)	1; 0; 0	—
SECONDARY Number of Subjects Reporting Serious Adverse Events (SAE)	—	—

Summary

The aim of this study is to evaluate the long-term persistence of hepatitis A antibodies at 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20 years after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine.

Eligibility Criteria

Inclusion Criteria

Subjects who had received at least one dose of the study vaccine in the primary study
Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00289757). 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.