Phase 3 N=244 Randomized Prevention

Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years

Hepatitis B · Hepatitis A

Bottom Line

View on ClinicalTrials.gov: NCT00197119 ↗

Enrolled (actual)

244

Serious AEs

0.0%

Results posted

Aug 2009

Primary outcome: Primary: Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value — 113; 100; 105; 92 subjects

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Twinrix™ Adult (Biological); Twinrix™ Junior (Biological)
Age: Pediatric · 12+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jun 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value	113; 100; 105; 92; 104; 93	—
PRIMARY Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value	100; 93; 98; 85; 96; 84	—
PRIMARY Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)	0; 0	—

Summary

To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.

Eligibility Criteria

Inclusion Criteria

Healthy male and female volunteers vaccinated in study HAB-084.
Written informed consent obtained from the subject before the blood sampling visit of each year.

Exclusion Criteria

none

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Data sourced from ClinicalTrials.gov (NCT00197119). 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.