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A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT01349829•Crucell Holland BV

View on ClinicalTrials.gov

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.

Eligibility

Age

1 - 3 years

Sex

ALL

Healthy Volunteers

Yes

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

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

Key Dates

Start Date

March 1, 2010

Primary Completion Date

April 1, 2011

Completion Date

April 1, 2011

Last Updated

December 17, 2013

Enrollment

251

ACTUAL participants

Conditions

Hepatitis A

Interventions

HAVpur Junior

BIOLOGICAL

Havrix 720 Junior

BIOLOGICAL

Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents

NCT07032610

Hepatitis AHepatitis A Virus+1 more

View study

COMPLETEDPHASE4

Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients

NCT03855176

Hepatitis AHuman Immunodeficiency Virus+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-term Immunogenicity of L-HAV Vaccine Among Healthy Thai Children and Adolescents

Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients

What is the Anti-HAV Seroprevalence of Travelers >60 Years or Having Lived in a Tropical Country for >5 Years

A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A

Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine

Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine