Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age

Summary

This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants \<6 months of age, followed by the booster at 12 months

Timeline

Start

2021-04-09

Primary completion

2022-09-09

Completion

2022-09-09

Publications

• Koski S, Martinon-Torres F, Ramet M, Zolotas L, Newton R, Maansson R, Cutler M, Peyrani P, Findlow J, Balmer P, Jodar L, Gruber WC, Anderson AS, Beeslaar J. A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix(R) Vaccine When Given to Healthy Infants at 3 and 12 Months of Age. Infect Dis Ther. 2025 Feb;14(2):463-481. doi: 10.1007/s40121-024-01098-8. Epub 2025 Jan 30.

Drugs

Indications