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
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.
Timeline
- Start
- 2019-12-27
- Primary completion
- 2021-03-24
- Completion
- 2021-03-24
Outcome
Met primary endpoint
paper Non-inferiority of NmCV-5 against MenACWY-D was met in terms of seroresponse rates and GMT ratios for all five serogroups. PMID 39521012 ↗
paper Lot-to-lot consistency of NmCV-5 was found for all five serogroups, with 95% CIs for the GMT ratio for each pair of lots being between 0·5 and 2 PMID 39521012 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Menactra | Vaccine | 0.5 ml | Intramuscular |
| Subject | NmCV-5 | Vaccine | 0.5 ml | Intramuscular |