A clinical trial to study safety and immunogenicity of two Hepatitis A vaccines in healthy young children aged between, and including, 18 months to 47 months, using a 0/6 month immunization schedule

A Phase IV open, randomized, controlled study to evaluate the safety and immunogenicity of a pediatric presentation (0.25 ml) of the virosomal hepatitis A virus (HAV) vaccine HAVpur® in healthy young children aged between, and including, 18 months to 47 months, using a 0/6 month immunization schedule

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000246

Enrollment

250

Registered

2010-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Hepatitis A antigen: 0.25 ml single dose to receive on Day 1 and at Month 6 Control Intervention1: Hepatitis A viral antigen: 0.5 ml single dose to receive on Day 1 and at Month 6

Eligibility

Inclusion criteria

Inclusion criteria: 1. A male or female between (and including) 18 months to 47 months of age. 2. Written informed consent obtained from the parent/legal guardian of the subject. 3. Free of obvious health problems as established by medical history and/or clinical examination before entering the study.

Exclusion criteria

Exclusion criteria: 1. Seropositive for anti-HAV antibodies (>/=10 mIU/ml). 2. Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up. 3. 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, such as prednisone, or equivalent, >/= 0.5 mg/kg/day. Inhaled and local steroids are allowed.) 4. Planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine. 5. Previous vaccination against hepatitis A. 6. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 7. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 8. Major congenital defects or serious chronic illness. 9. Acute disease at the time of enrolment.

Design outcomes

Primary

Measure	Time frame
The Primary Endpoint is proportion of subjects seroprotected at Month 1 (seroprotection defined as Anti-HAV Antibody concentration >/= 10mIU/ml)Timepoint: Seroprotection at month 1	—

Secondary

Measure	Time frame
Proportion of subjects seroprotected (>/= 10mIU/ml) at months 6 and 7 Proportion of subjects seroprotected (>/= 20mIU/ml) at months 1,6 and 7 GMCs at months 1, 6 and 7Timepoint: #seroprotection (>/= 10mIU/ml) at months 6 and 7 #seroprotected (>/= 20mIU/ml) at months 1,6 and 7 and #GMCs at months 1, 6 and 7	—

Countries

India

Contacts

Public ContactMr. Ambar Vaidya

Progenitor Clinical Research Pvt. Ltd.

svinze@progenitorint.com079 40066046

Outcome results