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Nimenrix Lot Consistency and Co-administration with Fluarix
NCT00453986Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2007
- Primary completion
- Nov 2007
- Countries
- 2
- Sponsor
- GSK
- Modality
- Recombinant Proteins and Enzymes, Vaccines & Immunotherapeutics
- Conditions
- meningococcal disease
01
Overview
Phase 3, randomised, double-blind trial of meningococcal group A, C, W135 and Y conjugate vaccine in meningococcal disease (5 arms), sponsored by GSK. Primary endpoints: Serum Bactericidal Assay (rSBA) Antibody Titers for Serogroups A, C, W-135, Y at 1 month, Vaccine Response for rSBA Antibody at 1 month and 3 more. Started Apr 2007; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Nimenrix Lot A
Nimenrix Lot A IM
Nimenrix Lot B
Nimenrix Lot B IM
Nimenrix Lot C
Nimenrix Lot C IM
Mencevax
Mencevax ACWY SC
Nimenrix + Fluarix
Nimenrix Lot A IM + Fluarix IM
03
Who it enrols
Healthy adults 18-55 years old, excluding those with prior meningococcal vaccination within 5 years, history of meningococcal disease, or immunodeficiency.
04
Endpoints
Primary
Serum Bactericidal Assay (rSBA) Antibody Titers for Serogroups A, C, W-135, Y
Vaccine Response for rSBA Antibody
Serum Haemagglutination Inhibition (HI) Antibody Titers
Seroconversion for HI Antibody Titers
Seroprotection for HI Antibody Titers
Secondary
Solicited Local and General Symptoms
Serious Adverse Events (SAEs)
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