A long-term follow up of a phase II open, randomised, controlled study to evaluate the safety and immunogenicity of a paediatric dose (0.25 ml) and the standard dose (0.5 ml) of Epaxal® with reference to Havrix Junior® in healthy children and adolescents (more than or equal to 12 months to 16 years of age), using a 0/6 month schedule

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17386851

Enrollment

308

Registered

2006-12-14

Start date

2006-12-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis A Infections and Infestations Hepatitis

Interventions

Interventions made in the primary study (EPA 001): 1. 0.25 ml Epaxal (12 IU hepatitis A antigen) 2. 0.50 ml Epaxal (24 IU hepatitis A antigen) 3. Comparator vaccine From each subject willing to p

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy children and adolescents 2. More than or equal to 12 months to 16 years of age 3. Enrolled and randomised in the primary study (EPA 001) and having received two doses of the study vaccines

Exclusion criteria

Exclusion criteria: 1. Subjects NOT enrolled and randomised in the primary study (EPA 001) 2. Subjects NOT having received two doses of the study vaccines

Design outcomes

Primary

Measure	Time frame
Proportion of subjects seroprotected five years after booster vaccination	—

Secondary

Measure	Time frame
Individual antibody titres and Geometric Mean antibody Titres (GMTs) one, two, three, four, and five years after booster vaccination.	—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026