Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

• Status: Completed
• Trial end date: 2006-11-23
• Target enrollment: 0
• Participant gender: All

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 diphtheria antigen after a three-dose primary vaccination course.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Vaccines

Criteria

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.