Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
|Haemophilus Influenzae Type b Diphtheria Tetanus Hepatitis B Whole Cell Pertussis||Biological: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Study to Assess Immunogenicity and Safety of GlaxoSmithKline Biologicals' Kft's DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs Concomitant Administration of CSL's Triple Antigen and GlaxoSmithKline Biologicals' Hiberix, to Infants at 2, 4, 6 Months of Age, After a Birth Dose of Hepatitis B|
- GMC of anti-BPT Ab
- anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT
- Solicited & unsolicited symptoms, SAEs "
|Study Start Date:||March 2006|
|Study Completion Date:||November 2006|
Biological: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
- hepatitis B
- Hib vaccine
"The study will be carried out in a partially double blind manner (i.e. double blind with respect to DTPwGöd-HBV/Hib Kft and DTPwCSL-HBV/Hib Kft groups and open with respect to CSL's Triple Antigen & Hib group). Subjects will be randomly allocated to one of the three following groups to receive:
- GSK Biologicals Kft's combined DTPwGöd-HBV/Hib Kft vaccine.
- GSK Biologicals Kft's combined DTPwCSL-HBV/Hib Kft vaccine.
- CSL's Triple Antigen + GSK Biologicals' Hib vaccines. There will be a specific follow-up of solicited local and general symptoms during 4 days after each vaccination and of unsolicited symptoms for 31 days after each vaccination. Serious adverse events reported during the study period will be recorded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316680
|GSK Investigational Site|
|Santo Domingo, Dominican Republic|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|