Evaluate the Feasibility of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Vaccine Administered as a 3 Dose Primary Vaccination Course at 6, 10 & 14 Weeks of Age

NCT00291967 Phase 2 COMPLETED

To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals' Hiberix™ vaccine and Tritanrix™-HepB vaccine mixed with Hiberix™ vaccine and concomitantly administered with Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), with respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP) after a three-dose primary vaccination course.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	COMPLETED
Enrolment	525
Start date	2002-11

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Hepatitis B
• Hib Diseases
• Neisseria Meningitidis Serogroups A & C Diseases

Interventions

• DTPw-HBV/Hib-MenAC conjugate vaccine

Primary outcomes

• One month after the third dose of the primary vaccination course, measurement of serum bactericidal titers against meningococcal serogroups A and C (SBA-MenA; SBA-MenC) and anti-PRP antibody concentration.

Countries

Philippines