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

Purpose

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.

Condition	Intervention	Phase
Hepatitis A	Biological: HAVpur Junior Biological: Havrix 720 Junior	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:

Seroprotection at Month 1 [ Time Frame: Month 1 ] [ Designated as safety issue: No ]
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)

Secondary Outcome Measures:

Seroprotection at Months 6 and 7 [ Time Frame: Months 6 and 7 ] [ Designated as safety issue: No ]
Proportion of subjects seroprotected (>=10 mIU/ml)
Seroprotection at Months 1, 6 and 7 [ Time Frame: Months 1, 6 and 7 ] [ Designated as safety issue: No ]
Proportion of subjects seroprotected (>=20 mIU/ml)
Geometric mean concentrations (GMCs) [ Time Frame: Months 1, 6 and 7 ] [ Designated as safety issue: No ]
GMCs of anti-HAV antibodies will be measured from blood samples
Solicited local and systemic adverse events [ Time Frame: For the 4 days following each vaccination ] [ Designated as safety issue: Yes ]
Proportion of subjects experiencing local and systemic adverse events after primary and after booster vaccination in the two study groups

Enrollment:	250
Study Start Date:	March 2010
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Months to 47 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349829

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	Crucell Holland BV
ClinicalTrials.gov Identifier:	NCT01349829 History of Changes
Other Study ID Numbers:	EPA-V-A008
Study First Received:	May 5, 2011
Last Updated:	September 15, 2011
Health Authority:	India: Drugs Controller General of India

Keywords provided by Crucell Holland BV:

Hepatitis A
Vaccination
Immunity

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human

Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on June 18, 2013