A phase III 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 comparator vaccine in healthy children and adolescents (12 months to 16 years of age inclusive), using a 0/6 month schedule

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91009479

Enrollment

360

Registered

2006-11-14

Start date

2006-11-01

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 Virus Infections and Infestations Hepatitis

Interventions

1) 0.25 ml Epaxal (12 IU hepatitis A antigen) 2) 0.50 ml Epaxal (24 IU hepatitis A antigen) 3) Comparator vaccine

Eligibility

Inclusion criteria

Inclusion criteria: Healthy children aged 12 months to 16 years inclusive.

Exclusion criteria

Exclusion criteria: 1. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed) 2. Previous vaccination against Hepatitis A Virus (HAV) 3. Seropositive for anti-HAV antibodies (screening Enzyme-Linked Immuno-Sorbent Assay [ELISA]) 4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including Human Immunodeficiency Virus (HIV) infection

Design outcomes

Primary

Measure	Time frame
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody titre greater or equal to 10 mIU/mL) one month after vaccination	—

Secondary

Measure	Time frame
1. Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody titre greater or equal to 10 mIU/mL) one month after booster vaccination. 2. Proportion of subjects with local and/or systemic adverse events after each vaccination.	—

Countries

Chile

Outcome results

None listed

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