A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children

Phase 4

Completed

• Conditions: Hepatitis A
• Interventions: Biological: HAVpur Junior; Biological: Havrix 720 Junior

• Registration Number: NCT01349829
• Lead Sponsor: Crucell Holland BV

Brief Summary

This is a study to test whether vaccination with HAVpur Junior against hepatitis A provides protection that is non-inferior to the protection afforded by vaccination with Havrix 720 Junior.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-05-05
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Status Verified: 2013-08
• Results First Submitted: 2013-10-25
• Results First Submitted QC: 2013-10-25
• Last Update Submitted: 2013-10-25
• Results First Posted: 2013-12-17
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

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

Exclusion Criteria

• Seropositive for anti-HAV antibodies (>=10 mIU/ml).
• 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.
• 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.)
• Planned administration/ administration of a measles containing vaccine within 4 weeks prior to and after the first or booster dose of study vaccine.
• Previous vaccination against hepatitis A.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAVpur	HAVpur Junior	-
Havrix	Havrix 720 Junior	-

Primary Outcome Measures

Name	Time	Method
Seroprotection at Month 1	Month 1	Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration \>=10 mIU/ml)

Secondary Outcome Measures

Name	Time	Method
Seroprotection at Month 6	Month 6	Proportion of subjects seroprotected (\>=10 mIU/ml)
Seroprotection at Month 7	Month 7	Proportion of subjects seroprotected (\>=10 mIU/ml)
Geometric Mean Concentrations (GMCs)	Month 7	GMCs of anti-HAV antibodies will be measured from blood samples

Trial Locations

Locations (3)

Medical College and Chacha Nehru Bal Chikitsalay; 🇮🇳 Indore, Madhya Pradesh, India

Rajiv Ghandi Medical College; 🇮🇳 Thane, Maharashtra, India

Christian Medical College and Hospital; 🇮🇳 Ludhiana, Punjab, India