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: Recruiting
Location: See all (10) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 5 months
Healthy Volunteers: t
View:

• Participant's parent(s)/Legally acceptable representative(s) \[LAR(s)\], who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., return for follow-up visits).

• Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.

• Healthy participants as established by medical history and clinical examination before entering the study.

• Born full term (i.e., after a gestation period of ≥37 weeks).

Locations
Other Locations
Republic of Korea
GSK Investigational Site
RECRUITING
Incheon
GSK Investigational Site
RECRUITING
Jeonju
GSK Investigational Site
RECRUITING
Junggu
GSK Investigational Site
RECRUITING
Kyungki-do
GSK Investigational Site
RECRUITING
Seongnam-si Gyeonggi-do
GSK Investigational Site
RECRUITING
Seoul
GSK Investigational Site
RECRUITING
Seoul
GSK Investigational Site
RECRUITING
Seoul
GSK Investigational Site
RECRUITING
Seoul
GSK Investigational Site
RECRUITING
Seoul
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 50
Treatments
Experimental: rMenB+OMV NZ Group
Participants received rMenB+OMV NZ on Day 1, Day 61, and any day between Day 241- Day 391.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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