NCT04358731 (ACYWX-04) is a Phase 2, PHASE3 clinical trial of NmCV-5 in Vaccine for Meningococcal Disease, sponsored by Serum Institute of India Pvt. Ltd..

Who is sponsoring NCT04358731?

NCT04358731 is sponsored by Serum Institute of India Pvt. Ltd..

What drugs are being tested in NCT04358731?

Interventions in NCT04358731: NmCV-5, Menactra.

What condition does NCT04358731 study?

NCT04358731 studies Vaccine for Meningococcal Disease.

Is NCT04358731 still recruiting?

NCT04358731 is currently completed. Last updated 8 September 2021.

Last reviewed 2021-09-08 · How we verify

NCT04358731: ACYWX-04

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age

Completed Phase 2, PHASE3 Last updated 8 September 2021

What this trial tests

Phase 2, PHASE3 trial testing NmCV-5 in Vaccine for Meningococcal Disease in 1,640 participants. Completed in 24 March 2021.

Timeline

27 December 2019

Primary endpoint
24 March 2021

24 March 2021

Quick facts

Lead sponsor	Serum Institute of India Pvt. Ltd.
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	1,640
Start date	27 December 2019
Primary completion	24 March 2021
Estimated completion	24 March 2021
Sites	11 locations across India

Drugs / interventions tested

NmCV-5 — full drug profile →
Menactra — full drug profile →

Conditions studied

Vaccine for Meningococcal Disease — all drugs for Vaccine for Meningococcal Disease →

Sponsor

Serum Institute of India Pvt. Ltd. — full company profile →

Who can join

Adults 18 to 85, any sex, with Vaccine for Meningococcal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 2/3, randomized, observer blind, multi-centre, controlled study to evaluate the safety, immune response and consistency of immune response of three consecutively manufactured lots of NmCV-5 in healthy individuals between the ages of 18 to 85 years (both inclusive). The immune response of NmCV-5 will also be statistically compared against a licensed conjugate vaccine against ACYW (Menactra). A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years. Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B \& C) of NmCV-5. All the randomized subjects will receive a single dose of 0.5 ml of NmCV-5 or Menactra on Day 1. Post vaccination site visits are planned on Days 8, 29 and 180 and a telephonic call at Day 85.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine versus a quadrivalent meningococcal conjugate vaccine in adults in India: an observer-blind, randomised, active-controlled, phase 2/3 study.
Kulkarni PS, Kawade A, Kohli S, Munshi R, et al · · 2025 · cited 3× · PMID 39521012 · DOI 10.1016/s1473-3099(24)00576-0

Verify or expand the search:

Other trials of NmCV-5

Trials testing the same drug.

NCT05093829 — Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine · Phase 3 · completed
NCT03964012 — Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5) · Phase 3 · completed

Other Serum Institute of India Pvt. Ltd. trials

Trials by the same sponsor.

NCT07009847 — An Observational Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine · recruiting
NCT06507605 — Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults · Phase 1 · completed
NCT06413121 — Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV · Phase 3 · recruiting
NCT05421611 — A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL · Phase 3 · completed
NCT05447377 — A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants · Phase 3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04358731 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Serum Institute of India Pvt. Ltd.
Last refreshed: 8 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04358731.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing