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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis A
• Intervention / Treatment: Biological: HAVpur Junior; Biological: Havrix 720 Junior

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Madhya Pradesh
    • Indore, Madhya Pradesh, India, 452001
      • Medical College and Chacha Nehru Bal Chikitsalay
  • Maharashtra
    • Thane, Maharashtra, India, 400 605
      • Rajiv Ghandi Medical College
  • Punjab
    • Ludhiana, Punjab, India, 141008
      • Christian Medical College and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HAVpur	Biological: HAVpur Junior; ≥12 International Units (IU) hepatitis A antigen coupled to virosomes, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus) Vaccination schedule: single doses at 0 and 6 months
Active Comparator: Havrix	Biological: Havrix 720 Junior; ≥720 ELISA Units (EU) hepatitis A antigen adsorbed to aluminium hydroxide, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus) Vaccination schedule: single doses at 0 and 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprotection at Month 1	Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprotection at Month 6	Proportion of subjects seroprotected (>=10 mIU/ml)	Month 6
Seroprotection at Month 7	Proportion of subjects seroprotected (>=10 mIU/ml)	Month 7
Geometric Mean Concentrations (GMCs)	GMCs of anti-HAV antibodies will be measured from blood samples	Month 1
Geometric Mean Concentrations (GMCs)	GMCs of anti-HAV antibodies will be measured from blood samples	Month 6
Geometric Mean Concentrations (GMCs)	GMCs of anti-HAV antibodies will be measured from blood samples	Month 7

Collaborators and Investigators

• Sponsor: Crucell Holland BV
• Investigators: Principal Investigator: Daljit Singh, MD, Dayanad Medical College and Hospital; Principal Investigator: Tejinder Singh, MD, Christian Medical College and Hospital; Principal Investigator: Hemant Jain, MD, Medical College and Chacha Nehru Bal Chikitsalay; Principal Investigator: Vardana Kumavat, MD, Rajiv Ghandi Medical College

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: May 5, 2011
• First Submitted That Met QC Criteria: May 6, 2011
• First Posted (Estimate): May 9, 2011

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: October 25, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Immunity; Vaccination; Hepatitis A
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A
• Other Study ID Numbers: EPA-V-A008