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

NCT ID: NCT01349829

Last Updated: 2013-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-04-30

Brief Summary

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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

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Conditions

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Hepatitis A

Keywords

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Hepatitis A Vaccination Immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HAVpur

Group Type EXPERIMENTAL

HAVpur Junior

Intervention Type BIOLOGICAL

≥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

Group Type ACTIVE_COMPARATOR

Havrix 720 Junior

Intervention Type BIOLOGICAL

≥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

Interventions

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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

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

47 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Crucell Holland BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daljit Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Dayanad Medical College and Hospital

Tejinder Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Christian Medical College and Hospital

Hemant Jain, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College and Chacha Nehru Bal Chikitsalay

Vardana Kumavat, MD

Role: PRINCIPAL_INVESTIGATOR

Rajiv Ghandi Medical College

Locations

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Medical College and Chacha Nehru Bal Chikitsalay

Indore, Madhya Pradesh, India

Site Status

Rajiv Ghandi Medical College

Thāne, Maharashtra, India

Site Status

Christian Medical College and Hospital

Ludhiana, Punjab, India

Site Status

Countries

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India

Other Identifiers

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EPA-V-A008

Identifier Type: -

Identifier Source: org_study_id