At a glance
ClinicalIndex Comparison Record- ✓Administration of one dose of hepatitis B vaccine at birth
- ✓Male or female infant between 11 and 17 weeks of age at first DTPw vaccination
- ✓Free of obvious health problems by medical history and clinical examination
- ✕Use of any investigational or non-registered product within 30 days before first study vaccine dose or planned use during study
- ✕Chronic administration of immunosuppressants or other immune-modifying drugs since birth
- ✕Planned or actual non-protocol vaccine administration within 30 days before first dose or during study, except oral polio vaccine
- ✕Any confirmed or suspected immunosuppressive or immunodeficient condition
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Partially Blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB and GSK Biologicals Kft's DTPw-HBV Vaccines as Compared to Concomitant Administration of Commonwealth Serum Laboratory's (CSL's) DTPw (Triple Antigen™) and GSK Biologicals' HBV (Engerix™-B), When Co-administered With GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, to Healthy Infants at 3, 4½ and 6 Months of Age, After a Birth Dose of Hepatitis B Vaccine.
In Brief
A Phase 3 clinical trial evaluating Tritanrix™-HepB, Rotarix™, and 4 other interventions for Hepatitis B. Completed, enrolled 308 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine.
GSK Biologicals' live attenuated human rotavirus vaccine
GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine
Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine.
GSK Biologicals' hepatitis B vaccine
Placebo for the Rotarix™ vaccine