Clinical trial NCT01349829: A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis A
Keywords: Hepatitis A
Vaccination
Immunity
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2011-05-09
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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

Primary outcomes:
measure: Seroprotection at Month 1
timeFrame: Month 1
Secondary outcomes:
measure: Seroprotection at Month 6
timeFrame: Month 6
measure: Seroprotection at Month 7
timeFrame: Month 7
measure: Geometric Mean Concentrations (GMCs)
timeFrame: Month 1
measure: Geometric Mean Concentrations (GMCs)
timeFrame: Month 6
measure: Geometric Mean Concentrations (GMCs)
timeFrame: Month 7
Other outcomes:
Locations:
city: Indore
country: India
facility: Medical College and Chacha Nehru Bal Chikitsalay
state: Madhya Pradesh
city: Thane
country: India
facility: Rajiv Ghandi Medical College
state: Maharashtra
city: Ludhiana
country: India
facility: Christian Medical College and Hospital
state: Punjab
Study officials:
affiliation: Dayanad Medical College and Hospital
name: Daljit Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christian Medical College and Hospital
name: Tejinder Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College and Chacha Nehru Bal Chikitsalay
name: Hemant Jain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rajiv Ghandi Medical College
name: Vardana Kumavat, MD
role: PRINCIPAL_INVESTIGATOR
References: