Phase 4
N=300
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
Hepatitis B Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT00519649 ↗Enrolled (actual)
300
Serious AEs
0.3%
Results posted
May 2009
Primary outcome: Primary: Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value — 275 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Engerix™-B Kinder (Biological)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value |
275 | — |
| SECONDARY Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value |
261; 235; 104 | — |
| SECONDARY Number of Participants Reporting Solicited Local Symptoms |
89; 81; 42 | — |
| SECONDARY Number of Participants Reporting Solicited General Symptoms |
44; 9; 23; 40 | — |
| SECONDARY Number of Participants Reporting Unsolicited Adverse Events |
71 | — |
| SECONDARY Number of Participants Reporting Serious Adverse Events (SAE) |
1 | — |
Summary
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
- With documented evidence of previous vaccination with three consecutive doses of Engerix™-B in Germany
- Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix™-B vaccine.
- History of or intercurrent hepatitis B disease.
- Hepatitis B vaccination at birth.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before HBV vaccine challenge and ending 30 days after.
- Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge or planned administration during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Data sourced from ClinicalTrials.gov (NCT00519649). 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.