Status:
COMPLETED
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Lead Sponsor:
GlaxoSmithKline
Conditions:
Acellular Pertussis
Diphtheria
Eligibility:
All Genders
16-20 years
Phase:
PHASE2
Brief Summary
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formu...
Detailed Description
This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.
Eligibility Criteria
Inclusion
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
- A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
- Written informed consent obtained from the parent or guardian of the subject
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
- Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
- Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2008
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00627458
Start Date
February 1 2008
End Date
August 18 2008
Last Update
June 6 2018
Active Locations (6)
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1
GSK Investigational Site
Jarvenpaa, Finland, 04400
2
GSK Investigational Site
Oulu, Finland, 90220
3
GSK Investigational Site
Pori, Finland, 28100
4
GSK Investigational Site
Tampere, Finland, 33100