Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
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|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)|
|Estimated 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|
|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 "
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|