Clinical Trial: Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 A

Brief Summary: 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.

Detailed Summary: Randomized study with five groups to receive one of the following vaccination regimens: One of the three formulations of GSK Biologicals’ Hib-MenAC mixed with GSK Biologicals’ Tritanrix™-HepB (3 different groups) GSK Biologicals’ Tritanrix™-HepB + GSK Biologicals’ Hiberix™ GSK Biologicals’ Tritanrix™-HepB mixed with GSK Biologicals’ Hiberix™ + Wyeth Lederle’s Meningitec™
Sponsor: GlaxoSmithKline

Current Primary Outcome: 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Immunogenicity: Before the first dose, antibody concentrations or titres against vaccine antigens (MenA, MenC, PRP, pertussis)
  • One month after the third dose, antibody concentrations or titres against all vaccine antigens
  • Reactogenicity & safety: after each dose: solicited (d 0-7, local & general) & unsolicited (d 0-30) symptoms
  • Over the full course of the study: serious adverse events (SAEs)


Original Secondary Outcome: Immunogenicity: Before the first dose, antibody concentrations or titres against vaccine antigens (MenA, MenC, PRP, pertussis). One month after the third dose, antibody concentrations or titres against all vaccine antigens

Information By: GlaxoSmithKline

Dates:
Date Received: February 14, 2006
Date Started: November 2002
Date Completion:
Last Updated: December 7, 2006
Last Verified: December 2006