NCT03964012

Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)

Phase 3, Observer-blind, Randomized, Active Controlled Trial to Assess the Safety of an Investigational Meningococcal Serogroups ACYWX Conjugate Vaccine (NmCV-5) and Compare Its Immunogenicity to a Licensed Meningococcal Serogroups ACYW Conjugate Vaccine (Menactra®), in Healthy Subjects 2 to 29 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (actual)
• Sponsor: Serum Institute of India Pvt. Ltd. · Industry
• Sex: All
• Age: 2 Years – 29 Years
• Healthy volunteers: Accepted

Summary

This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra. A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years \& 2-10 years (400 NmCV-5 recipients \& 200 Menactra recipients in each age strata). Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA).

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	NmCV-5	Polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W\&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A\&X conjugated to tetanus toxoid and C,Y\&W conjugated to C reactive material (CRM) protein. The diluent is Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
BIOLOGICAL	Menactra	Menactra is available as ready to use solution containing polysaccharide antigens A,C,Y\&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine

Timeline

• Start date: 2019-08-20
• Primary completion: 2020-02-23
• Completion: 2021-03-04
• First posted: 2019-05-28
• Last updated: 2021-07-27

Locations

2 sites across 2 countries: Mali, The Gambia