Status:
COMPLETED
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
11-17 years
Phase:
PHASE3
Brief Summary
This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infant...
Eligibility Criteria
Inclusion
- A male or female infant at the age of 11 - 17 weeks.
- Written informed consent obtained from the parents or guardians of the subject.
- Free of obvious health problems as established by clinical examination before entering into the study.
- Hepatitis B vaccine at birth and one month of age.
Exclusion
- Previous vaccination against measles, mumps, rubella and/or varicella.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
- Major congenital defects.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2002
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00366366
Start Date
September 1 2001
End Date
September 1 2002
Last Update
September 16 2016
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.