Status:
COMPLETED
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose
Lead Sponsor:
GlaxoSmithKline
Conditions:
Tetanus
Diphtheria
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
Brief Summary
The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vacc...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
- Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primary study DTPa-HBV-IPV=Hib-MenC-TT-002 (112157).
- A male or female between, and including, 12 and 18 months of age at the time of booster vaccination.
- Written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the 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 vaccination.
- Planned administration/administration of immunoglobulins and/or any blood products within three months before the booster dose, or during the study period.
- Planned administration/administration of any vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after the booster dose.
- Participation in another clinical study since the primary study DTPa-HBV-IPV/Hib-MenC-TT-002 in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib, pneumococcal and MenC vaccination or disease since the conclusion visit of study DTPa-HBV-IPV/Hib-MenC-TT-002.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- The following adverse event having occurred after previous administration of DTP vaccine:
- Encephalopathy.
- Temperature of \>= 40.5°C (rectal temperature) within 48 hours of vaccination, not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of vaccination.
- Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting \>= 3 hours.
- Seizures with or without fever occurring within 3 days of vaccination.
- The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- • Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
Key Trial Info
Start Date :
August 18 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2010
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT01171989
Start Date
August 18 2010
End Date
December 3 2010
Last Update
January 21 2020
Active Locations (9)
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1
GSK Investigational Site
Bydgoszcz, Poland, 85-021
2
GSK Investigational Site
Dębica, Poland, 39-200
3
GSK Investigational Site
Krakow, Poland, 31-422
4
GSK Investigational Site
Krakow, Poland, 31-503