Status:
COMPLETED
Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Whole Cell Pertussis
Diphtheria
Eligibility:
All Genders
10-18 years
Phase:
PHASE3
Brief Summary
To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
Detailed Description
* Subjects who received DTPw-HBV/Hib in the primary vaccination without HBV at birth will be randomised (1:3 ratio) to receive either: Plain PRP at 10 months of age followed by DTPw-HBV at 15-18 month...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- For subjects receiving Plain PRP followed by DTPw-HBV:
- Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.
- For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:
- Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.
- For all subjects:
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
- Free of obvious health problems as established by medical history and clinical examination
- Exclusion criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
- Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
Exclusion
Key Trial Info
Start Date :
February 10 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2006
Estimated Enrollment :
745 Patients enrolled
Trial Details
Trial ID
NCT00169442
Start Date
February 10 2005
End Date
March 10 2006
Last Update
June 6 2018
Active Locations (3)
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1
GSK Investigational Site
City of Muntinlupa, Philippines, 1781
2
GSK Investigational Site
Pasay, Philippines
3
GSK Investigational Site
Quezon City, Philippines, 1109