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Immunogenicity & Safety of Nimenrix Co-Administered with Priorix-Tetra in Toddlers
NCT00474266Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2007
- Primary completion
- Feb 2008
- Countries
- 1
- Sponsor
- GSK
- Modality
- Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Conditions
- meningococcal infection
01
Overview
Phase 3, randomised, open-label trial of meningococcal group A, C, W135 and Y conjugate vaccine in meningococcal infection (4 arms), sponsored by GSK. Primary endpoints: Serum Bactericidal Antibody titers (rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY) at Day 42 and Anti-measles, Anti-mumps, Anti-rubella, Anti-varicella Antibody Concentrations at Day 42. Started Jun 2007; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
Nimenrix + Priorix-Tetra Group
Nimenrix + Priorix-Tetra at Day 0, Priorix-Tetra at Day 84
Nimenrix Group
Nimenrix at Day 0, Priorix-Tetra at Day 42, Priorix-Tetra at Day 84
Priorix-Tetra Group
Priorix-Tetra at Day 0, Meningitec at Day 42, Priorix-Tetra at Day 84
Meningitec Group
Meningitec at Day 0, Priorix-Tetra at Day 42, Priorix-Tetra at Day 84
03
Who it enrols
Healthy male or female children between 12 and 23 months of age, free of obvious health problems, with no previous vaccination against meningococcal disease or MMRV.
04
Endpoints
Primary
Serum Bactericidal Antibody titers (rSBA-MenC, rSBA-MenA, rSBA-MenW-135, rSBA-MenY)
Anti-measles, Anti-mumps, Anti-rubella, Anti-varicella Antibody Concentrations
Secondary
Solicited Local and General Symptoms
Serious Adverse Events
Geometric Mean Titers/Concentrations
05
Results
Primary endpoints met
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