Status:
COMPLETED
Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis A
Hepatitis B
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
This study will evaluate the persistence of the immune response to HAV (Hepatitis A Virus) antigens and HBs (Hepatitis B surface) antigens in healthy adults previously vaccinated with GlaxoSmithKline ...
Eligibility Criteria
Inclusion
- All subjects must satisfy the following criteria at entry into each of the long-term follow-up visits:
- 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 primary vaccination course in the primary study Hepatitis A and B vaccine (HAB), HAB-028 (208127/021).
- Written informed consent obtained from the subject.
- All subjects must satisfy the following criteria at entry into the challenge dose phase:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female who received the complete primary vaccination course in the primary study HAB-028 (208127/021).
- Written informed consent obtained from the subject.
- Subjects who participated in the long-term follow-up (LTFU) phase of the HAB-028 (208127/021) study and for whom the antibody concentrations were below the cut-off at the last available follow-up time-point.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception for two months after the administration of the challenge dose.
Exclusion
- The following criteria should be checked before entry into each of the long-term follow-up visits. If any exclusion criterion applies, the subject must not be included in the study:
- Use of any investigational or non-registered product within 30 days prior to blood sampling.
- Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine outside the study procedures, since the primary study HAB-028 (208127/021).
- History of hepatitis A or hepatitis B infection since the primary study HAB-028 (208127/021).
- Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within three months prior to blood sampling.
- The following criteria should be checked before the challenge dose is administered. If any apply, the subject must not be included in the challenge dose phase:
- Use of any investigational or non-registered product within 30 days prior to study start or planned use during the study.
- Administration of a hepatitis A, hepatitis B or combined hepatitis A and B vaccine between the last LTFU visit and the challenge dose visit.
- History of hepatitis A or hepatitis B infection between the last LTFU visit and the challenge dose visit.
- History of anaphylactic reactions following the administration of vaccines.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Acute disease and/or fever at the time of enrolment.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Key Trial Info
Start Date :
November 6 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01000324
Start Date
November 6 2009
End Date
July 25 2014
Last Update
September 4 2018
Active Locations (1)
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1
GSK Investigational Site
Wilrijk, Belgium, 2610