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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

StatusActive, Not Recruiting
PhasePhase 4
Started2023-11-10
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 4 times since 2023-10-27; most recent filed 2026-03-31. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-03-31
Amendment Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v4
2025-08-06
Amendment Study Status, Contacts/Locations v3
2025-05-16
Amendment Study Status, Contacts/Locations v2
2024-11-04
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
2023-10-27
Original filing
Trial Details
NCT Number NCT06113198
Lead Sponsor GlaxoSmithKline
Conditions Meningitis, Meningococcal
Enrollment 50 participants
Start Date 2023-11-10
Primary Completion 2026-09-07 (estimated)
Study Completion 2027-02-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-06