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Intradermal vs Subcutaneous Menomune Administration
NCT00850603Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2002
- Primary completion
- May 2003
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- meningococcal infectionmeningitis
01
Overview
Phase 4, randomised trial of quadrivalent meningococcal polysaccharide vaccine in meningococcal infection and meningitis (5 arms), sponsored by Sanofi. Primary endpoints: Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers at 28 days and Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Day 28. Started Oct 2002; status: completed.
02
Design
5 arms- Study design
- Randomized
Standard SC
0.5 mL Subcutaneous Menomune
Low-dose SC
0.1 mL Subcutaneous Menomune
ID 0.05 mL
0.05 mL Intradermal Menomune
ID 0.1 mL
0.1 mL Intradermal Menomune
ID 0.15 mL
0.15 mL Intradermal Menomune
03
Endpoints
Primary
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup
Secondary
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination
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