Status:
COMPLETED
Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Poliomyelitis
Eligibility:
All Genders
18-24 years
Phase:
PHASE3
Brief Summary
The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster dose to Chinese children at 18-24 months of age.
Eligibility Criteria
Inclusion
- A male or female toddler between, and including, 18 and 24 months of age at the time of the booster vaccination.
- Subjects who received three doses of OPV as primary vaccination in the first year of life as per Chinese recommendations.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- 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 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 vaccination
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP and/or Hib vaccine(s).
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination, or planned administration during the study period.
- 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
- Previous booster vaccination against poliomyelitis since the end of the primary vaccination series.
- History of poliomyelitis disease.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Major congenital defects or serious chronic illness.
- The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- • Current febrile illness or axillary temperature \> 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00920439
Start Date
June 1 2009
End Date
August 3 2009
Last Update
January 19 2018
Active Locations (1)
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1
GSK Investigational Site
Wuzhou, Guangxi, China, 543002