Status:
COMPLETED
Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
19-22 years
Phase:
PHASE4
Brief Summary
This study will evaluate the immune response of healthy subjects who received neonatal vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago. The presence of immune m...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female who received the complete neonatal primary vaccination course of Engerix™-B in the 103860/273 primary study approximately 20 years earlier.
- Anti-HBs antibody concentrations less than the specified value at the last available follow-up time-point.
- Written informed consent obtained from 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 completion of the vaccination.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the Engerix™-B challenge dose, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to challenge dose administration.
- Planned administration/ administration of a vaccine not foreseen by the study protocol starting from 30 days before the challenge dose and ending 30 days after.
- Administration of a hepatitis B vaccine outside the context of this study between the follow-up time-point at which anti-HBs antibody concentrations was less than the specified value and the current challenge dose study 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.
- Acute disease at the time of enrolment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Acute or chronic, clinically significant pulmonary, cardiovascular, 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 challenge dose visit or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00774995
Start Date
November 1 2008
End Date
June 1 2010
Last Update
November 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Bangkok, Thailand, 10330