Status:
COMPLETED
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
3-4 years
Phase:
PHASE3
Brief Summary
To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheri...
Detailed Description
Randomized study with five groups to receive one of the following vaccination regimens: One of the two formulations of GSK Biologicals' DTPw-HBV + GSK Biologicals' HRV One of the two formulations of ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
- Administration of one dose of hepatitis B vaccine at birth.
- A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Exclusion
Key Trial Info
Start Date :
September 12 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2006
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00158756
Start Date
September 12 2005
End Date
November 23 2006
Last Update
June 6 2018
Active Locations (9)
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1
GSK Investigational Site
Barnaul, Russia, 656049
2
GSK Investigational Site
Ivanteevka Moscow Region, Russia, 141280
3
GSK Investigational Site
Krasnoyarsk, Russia, 660027
4
GSK Investigational Site
Moscow, Russia, 119991