MedTrace Logo

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

NCT03964012 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2021-07-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • PATH

    collaborator OTHER

  • Serum Institute of India Pvt. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2020-02-23
Completion
2021-03-04

Countries

  • Mali
  • The Gambia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03964012 on ClinicalTrials.gov