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

Hepatitis A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349829
• Other study ID #: EPA-V-A008
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2011
• Last updated: October 25, 2013
• Start date: March 2010
• Est. completion date: April 2011

Study information

• Verified date: August 2013
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 47 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

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
• 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

Locations

Country	Name	City	State
India	Medical College and Chacha Nehru Bal Chikitsalay	Indore	Madhya Pradesh
India	Christian Medical College and Hospital	Ludhiana	Punjab
India	Rajiv Ghandi Medical College	Thane	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprotection at Month 1	Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)	Month 1	No
Secondary	Seroprotection at Month 6	Proportion of subjects seroprotected (>=10 mIU/ml)	Month 6	No
Secondary	Seroprotection at Month 7	Proportion of subjects seroprotected (>=10 mIU/ml)	Month 7	No
Secondary	Geometric Mean Concentrations (GMCs)	GMCs of anti-HAV antibodies will be measured from blood samples	Month 1	No
Secondary	Geometric Mean Concentrations (GMCs)	GMCs of anti-HAV antibodies will be measured from blood samples	Month 6	No
Secondary	Geometric Mean Concentrations (GMCs)	GMCs of anti-HAV antibodies will be measured from blood samples	Month 7	No