NCT06113198

A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age

A Phase 4, Single-arm, Open-label, Multi-center Study to Assess the Immune Response and Safety of the Meningococcal Group B Vaccine MenB+OMV NZ When Administered to Healthy Infants From 2 Months of Age in the Republic of Korea

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Months – 5 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and immune responses of rMenB+OMV NZ vaccine when administered to healthy infants from 2 months in the Republic of Korea according to a 2-dose primary schedule and 1 booster dose.

Detailed description

As a post-approval commitment to the Ministry of Food and Drug Safety, Bexsero, which is approved in the Republic of Korea for active immunization against MenB, participants will receive a primary series of 2 doses of rMenB+OMV NZ vaccine, with the first dose given at 2 to 5 months of age and the second dose 2 months later. A third dose (booster) will be administered at 12 to 15 months of age. Routine infant vaccines may be administered as per the Korean Routine Immunization Schedule. However, there will be a minimum interval of 14 days before and after the administration of rMenB+OMV NZ vaccine or any other vaccine (21 days for live attenuated vaccines and 7 days for influenza vaccines).

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	rMenB+OMV NZ	3 doses of rMenB+OMV NZ vaccine administered intramuscularly on Day 1, Day 61, and any day between Day 241 - Day 391.

Timeline

• Start date: 2023-11-10
• Primary completion: 2026-09-07
• Completion: 2027-02-08
• First posted: 2023-11-02
• Last updated: 2026-04-06

Locations

8 sites across 1 country: South Korea