Status:
COMPLETED
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
11-17 years
Phase:
PHASE4
Brief Summary
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals'...
Detailed Description
Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study. 3-4-5 month schedule with a booster dose at 18 months
Eligibility Criteria
Inclusion
- Inclusion criteria
- Subjects must have been enrolled in the Rota-028 study.
- A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- Exclusion criteria
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Exclusion
Key Trial Info
Start Date :
November 2 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2007
Estimated Enrollment :
2590 Patients enrolled
Trial Details
Trial ID
NCT00325156
Start Date
November 2 2004
End Date
August 23 2007
Last Update
January 2 2020
Active Locations (1)
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1
GSK Investigational Site
Singapore, Singapore, 308433