Status:
COMPLETED
Evaluation of Antibody Persistence & Immune Memory in Subjects Vaccinated During Adolescence With Twinrix™
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Hepatitis A
Eligibility:
All Genders
12-15 years
Phase:
PHASE4
Brief Summary
This study will evaluate the immune response against Hepatitis-A (HAV) and Hepatitis B surface (HBs) antigen in healthy subjects aged 12 to 15 years (at the time of primary vaccination), who received ...
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 primary vaccination course according to his/her group allocation in the primary study
- Written informed consent obtained from the subject.
- All subjects must satisfy the following criteria at entry into the challenge dose phase:
- A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study.
- Subjects who participated in the long-term follow-up phase of the primary study and for whom the antibody concentrations were below specified value for anti-HAV antibodies and/ or for anti-HBs antibodies at the last available follow-up time-points.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the challenge dose phase of this study.
- If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after the vaccination.
Exclusion
- The following criteria should be checked at each follow-up visit. If any apply at study entry, the subject must not be included at that long-term follow-up visit.
- Use of any investigational or non-registered product (drug or vaccine) since the last blood sampling visit.
- Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine since the primary vaccination course of the primary study.
- History of hepatitis A or hepatitis B infection.
- Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within 3 months prior to blood sampling.
- The following criteria should be checked before the challenge dose phase. If any apply, the subject must not be included in the challenge dose phase:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days before the administration of the challenge dose or planned use during the study period outside the context of the study.
- Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine between the primary vaccination course of the primary study and the challenge dose visit.
- History of hepatitis A or hepatitis B infection.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Acute disease at the time of.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the challenge dose or planned administration before the final blood sampling point (one month after the challenge dose).
- Pregnant or lactating female.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00875485
Start Date
May 1 2009
End Date
July 1 2014
Last Update
August 20 2018
Active Locations (2)
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1
GSK Investigational Site
Brussels, Belgium, 1200
2
GSK Investigational Site
Hradec Králové, Czechia, 500 03