Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
|ClinicalTrials.gov Identifier: NCT00316680|
Recruitment Status : Terminated
First Posted : April 21, 2006
Last Update Posted : October 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Haemophilus Influenzae Type b Diphtheria Tetanus Hepatitis B Whole Cell Pertussis||Biological: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine||Phase 3|
"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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2006|
|Actual Study Completion Date :||November 2006|
Biological: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
- hepatitis B
- Hib vaccine
- 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 "
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00316680
|GSK Investigational Site|
|Santo Domingo, Dominican Republic|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|