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Phase 3 Trial of NmCV-5 vs MenACWY-TT in Healthy Malian Infants
NCT05093829Phase 3
Key facts
- Status
- Completed
- Start
- Mar 2022
- Primary completion
- Mar 2023
- Countries
- 1
- Sponsor
- Emory University
- Modality
- Split/Subunit Vaccines
- Drugs
- NmCV-5
- Conditions
- meningitis
01
Overview
Phase 3, randomised trial of NmCV-5 in meningitis (4 arms), sponsored by Emory University. Primary endpoints: Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y at Day 29 and Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT) at Day 29. Started Mar 2022; status: completed.
02
Design
4 arms- Study design
- Randomized
9 months NmCV-5
Vaccination at 9 months of age with NmCV-5
9 months MenACWY-TT
Vaccination at 9 months of age with MenACWY-TT
15 months NmCV-5
Vaccination at 15 months of age with NmCV-5
15 months MenACWY-TT
Vaccination at 15 months of age with MenACWY-TT
03
Who it enrols
Healthy infants aged 9-11 months or 15-17 months, with no prior meningococcal or measles vaccination, no severe malnutrition, and no active infections including malaria, HIV, or Hepatitis B/C.
04
Endpoints
Primary
Number of Participants With Seroprotection for Meningitis Serogroups A, C, W and Y
Number of Participants With Seroprotection for Meningitis Serogroup X (NmCV-5) vs Lowest Comparator (MenACWY-TT)
Secondary
Number of Participants With Serious Adverse Events
Number of Participants With Solicited Adverse Events (Reactogenicity)
Number of Participants With Unsolicited Adverse Events
Number of Participants With Seroprotection for Meningitis Serogroup X
Number of Participants With Seropositive Response to Measles Vaccine
Number of Participants With Seropositive Response to Rubella Vaccine
Number of Participants With Seroprotective Response to Yellow Fever Vaccine
Geometric Mean of rSBA Titers for Meningitis Serogroups A, C, W, Y and X
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