NCT04358731

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

A Phase 2/3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,640 (actual)
• Sponsor: Serum Institute of India Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Vaccine for Meningococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	NmCV-5	The NmCV-5 is a fixed-combination available as the lyophilized powder containing meningococcal groups A and X polysaccharides conjugated to tetanus toxoid and meningococcal groups C, W and Y polysaccharides conjugated to CRM197 protein. The vaccine will be reconstituted with normal saline just prior to administration. The NmCV-5 lyophilized powder component contains sucrose, sodium citrate and trometamol as excipients. This component is presented as a freeze-dried powder in a single dose vial. No preservative or adjuvant is present in the vaccine. The normal saline diluent is a sterile clear colorless liquid in a single dose glass ampoule.
BIOLOGICAL	Menactra	The control vaccine is the licensed meningococcal serogroups ACYW conjugate vaccine (Menactra), manufactured by Sanofi Pasteur Incorporated. Menactra is supplied as a single 0.5 mL dose formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg each of meningococcal A, C, Y, and W polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier. No preservative or adjuvant is added during manufacture.

Timeline

• Start date: 2019-12-27
• Primary completion: 2021-03-24
• Completion: 2021-03-24
• First posted: 2020-04-24
• Last updated: 2021-09-08

Locations

11 sites across 1 country: India