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.

Condition	Intervention	Phase
Prophylaxis of diphtheria, tetanus, pertussis and hepatitis B diseases	Vaccine: Diphtheria, tetanus, pertussis and hepatitis B vaccine	Phase III

Further Study Details: 

Primary Outcomes: One month after the third dose of the primary vaccination course, anti-diphtheria antibody concentration.
Secondary Outcomes: "One month after the third dose of the primary vaccination course: antibody concentrations or titres against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B, rotavirus and poliovirus antigens); Reactogenicity and safety:;  Occurrence of solicited symptoms during the specific follow-up period after each dose.;  Occurrence of unsolicited symptoms during the specific follow-up period after each dose.;  Occurrence of serious adverse events over the full course of the study."
Expected Total Enrollment:  330

"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 GSK Biologicals’ DTPw-HBV + Placebo CSL’s DTPw + GSK Biologicals’ HBV"

Ages Eligible for Study:  up to  4 Months,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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. "

Please refer to this study by ClinicalTrials.gov identifier  NCT00158756

Clinical Coordinator      +1.877.379.37.18 

Russian Federation
      Moscow,  Russian Federation

Study chairs or principal investigators

Clinical Trials,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  104021
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00158756
Health Authority: Russia: Pharmacological Committee, Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-13