Table 3.

Clinical trials conducted with MenFive.

Phase	Study Site(s)	Population	Number of subjects (NmCV-5/comparator)	Primary Objective	Status	Summary
1	US	18–45 years	20/20/20	Safety	Complete26	Demonstrated initial NmCV-5 safety and immunogenicity in adults.
2	Mali	12–16 months	150/150/75	Safety	Complete27	Demonstrated safety and immunogenicity in toddlers. Demonstrated boosting of DT and TT immune responses.
3	Mali and The Gambia	2–29 years	1200/600	Non-inferiority compared to licensed Men ACWY-D vaccine.	Complete28	Immunological non-inferiority demonstrated. Immunological persistence demonstrated through 12 months.
2/3	India	18–85 years	1230/410	Non-inferiority compared to licensed Men ACWY-D vaccine and lot-to-lot consistency	Complete29	Non-inferiority and lot-to-lot consistency demonstrated.
3	Mali	9–15 months	800/400	Non-inferiority compared to licensed ACWY-T vaccine and EPI non-interference	Ongoing (partial results available)30	Non-inferiority and EPI compatibility demonstrated.