Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine … (NCT01106092) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers
Philippines312 participantsStarted 2010-05-13
Plain-language summary
The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.
Who can participate
Age range12 Months – 24 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
* Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
* 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 Criteria:
* Use of any investigational or non-registered product other than the study vaccine(s) 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 dose.
* Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
* 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.
* History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
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What they're measuring
1
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Timeframe: One month after booster vaccination (At Month 1)
2
Anti-polio Types 1, 2 and 3 Antibody Titers
Timeframe: Prior to booster vaccination (At Month 0)
3
Anti-polio Types 1, 2 and 3 Antibody Titers
Timeframe: One month after booster vaccination (At Month 1)