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NmCV-5 vs Menactra in Healthy Adults
NCT04358731Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2019
- Primary completion
- Mar 2021
- Countries
- 1
- Sponsor
- Serum Institute of India
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- Non-Adjuvanted MCV-5
- Conditions
- meningococcal disease
01
Overview
Phase 3, randomised, single-blind trial of Non-Adjuvanted MCV-5 in meningococcal disease (2 arms), sponsored by Serum Institute of India. Primary endpoints: rSBA assay Geometric Mean Titers at 29 days and Percentage of subjects with seroresponse at 28 days. Started Dec 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
NmCV-5
Single dose of NmCV-5 (MenFive)
Menactra
Single dose of Menactra
03
Who it enrols
Healthy adults 18-85 years of age. Excludes pregnant females, those with history of meningococcal vaccine or disease, and those with recent exposure to N. meningitidis.
04
Endpoints
Primary
rSBA assay Geometric Mean Titers
Percentage of subjects with seroresponse
Secondary
rSBA assay Geometric Mean Titers
05
Results
Primary endpoints met
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