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ACTIVE NOT RECRUITING
NCT06113198
PHASE4

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

2 Months - 5 Months

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-11-10

Completion Date

2027-02-08

Last Updated

2026-04-06

Healthy Volunteers

Yes

Interventions

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.

Locations (8)

GSK Investigational Site

Incheon, South Korea

GSK Investigational Site

Junggu, South Korea

GSK Investigational Site

Kyungki-do, South Korea

GSK Investigational Site

Seongnam-si Gyeonggi-do, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea