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Completed

NCT Number: NCT01349829

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

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.

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Key information

Age range

18 month–47 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical College and Chacha Nehru Bal Chikitsalay, Indore, Madhya Pradesh, India

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HAVpur Junior

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 720 Junior

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

Primary outcomes

  1. Seroprotection at Month 1

    Time frame: Month 1

    Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)

Secondary outcomes

  1. Seroprotection at Month 6

    Time frame: Month 6

    Proportion of subjects seroprotected (>=10 mIU/ml)

  2. Seroprotection at Month 7

    Time frame: Month 7

    Proportion of subjects seroprotected (>=10 mIU/ml)

  3. Geometric Mean Concentrations (GMCs)

    Time frame: Month 1

    GMCs of anti-HAV antibodies will be measured from blood samples

  4. Geometric Mean Concentrations (GMCs)

    Time frame: Month 6

    GMCs of anti-HAV antibodies will be measured from blood samples

  5. Geometric Mean Concentrations (GMCs)

    Time frame: Month 7

    GMCs of anti-HAV antibodies will be measured from blood samples

Sponsors and collaborators

Lead sponsor

Crucell Holland BV

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 9, 2011
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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