Demonstrate non-inferiority of GSK Biologicals' Tritanrix-HepB/Hib-MenAC vs Tritanrix-HepB/Hiberix with respect to anti-HBs immune response, when given to healthy infants at 6, 10 and 14 wks age, after a birth dose of hepatitis B vaccine.
Phase of Trial: Phase III
Latest Information Update: 30 Sep 2011
At a glance
- Drugs Hib-DTP-hepatitis B-meningococcal vaccine groups A and C conjugate (Primary) ; Hib-DTP hepatitis B vaccine (Tritanrix-HepB/Hiberix); Meningococcal vaccine groups A C Y W-135 polysaccharide
- Indications Diphtheria; Haemophilus infections; Hepatitis B; Meningococcal infections; Pertussis; Tetanus
- Focus Pharmacodynamics; Registrational
- Sponsors GlaxoSmithKline
- 30 Sep 2011 Actual initiation date (April 2006) added as reported by ClinicalTrials.gov.
- 09 Oct 2008 Trial centres updated from NCT.
- 09 Oct 2008 Checked against ClinicalTrials.gov record - last updated 9 Oct 2008.