Status:
COMPLETED
Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hib Disease
Hepatitis B
Eligibility:
All Genders
15+ years
Phase:
PHASE2
Brief Summary
To assess the anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine
Detailed Description
All subjects were previously primed with one of the two formulations of the combined DTPw-HBV/Hib vaccine. At the age of 10 months, 50% of each group received a plain PRP challenge to assess the immun...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female of at least 15 months of age at the time of the booster vaccination, who had previously received 3-dose primary vaccination and, if applicable, plain-PRP vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering the study.
- Exclusion criteria for enrolment
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B or Hib with the exception of plain PRP challenge.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00158808
Start Date
January 1 2005
End Date
April 1 2005
Last Update
May 30 2017
Active Locations (1)
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1
GSK Investigational Site
City of Muntinlupa, Philippines, 1781