Phase 4
N=144
Challenge Dose of Hepatitis B Vaccine in Subjects Who Previously Received Engerix™-B Vaccine
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00524576 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcome: Primary: Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration — 53; 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Engerix™-B (Biological)
- Age
- Pediatric, Adult · 17+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Immunological Response to Challenge Dose in Terms of Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration |
53; 21 | — |
| SECONDARY Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value |
53; 21; 53; 21; 50; 20 | — |
| SECONDARY Concentration of Anti-HBs Antibodies |
6214.1; 16564.3 | — |
| SECONDARY Number of Participants Reporting Solicited Local Symptoms |
22; 4; 11; 1; 9; 0 | — |
| SECONDARY Number of Participants Reporting Solicited General Symptoms |
19; 7; 1; 0; 7; 4 | — |
| SECONDARY Number of Participants Reporting Unsolicited Adverse Events (AE) |
19; 5 | — |
| SECONDARY Number of Participants Reporting Serious Adverse Events (SAE) |
0; 0 | — |
Summary
To evaluate the response to an additional dose (challenge dose) of hepatitis B vaccine, when given to subjects who had received primary vaccination of Engerix™-B vaccine approximately 72-78 months ago.
This protocol posting deals with objectives & outcome measures of the challenge phase. 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 they can and will comply with the requirements of the protocol.
- A male or female who had received complete primary vaccination course of hepatitis B vaccine in the primary study
- Written informed consent obtained from the subject and/or parent/guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after the hepatitis B challenge dose.
Exclusion Criteria
- Use of any investigational/non-registered drug or vaccine other than the study vaccine within 30 days preceding the hepatitis B vaccine challenge dose or planned use during the study period.
- Chronic administration (more than 14 days) of immunosuppressants other immune-modifying drugs within six months prior to the hepatitis B vaccine challenge dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the hepatitis B vaccine challenge dose and ending 30 days after.
- Subjects who received an additional dose of hepatitis B vaccine outside the context of the study between the primary vaccination course and the hepatitis B challenge vaccination visit.
- 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.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the hepatitis B vaccine challenge dose or planned administration during the study period (one month).
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Data sourced from ClinicalTrials.gov (NCT00524576). 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.