Phase 4
N=251
A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
Hepatitis A
Bottom Line
View on ClinicalTrials.gov: NCT01349829 ↗Enrolled (actual)
251
Serious AEs
0.4%
Results posted
Dec 2013
Primary outcome: Primary: Seroprotection at Month 1 — 95.9; 96.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- HAVpur Junior (Biological); Havrix 720 Junior (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Crucell Holland BV
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroprotection at Month 1 |
95.9; 96.6 | — |
| SECONDARY Seroprotection at Month 6 |
98.3; 99.0 | — |
| SECONDARY Seroprotection at Month 7 |
100; 100 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) |
1712.4; 2226.4 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) |
1712.4; 2226.4 | — |
| SECONDARY Geometric Mean Concentrations (GMCs) |
1712.4; 2226.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT01349829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.