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COMPLETED
NCT05082285
PHASE2

A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenACWY-7b) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

Official title: A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants

Key Details

Gender

All

Age Range

55 Days - 89 Days

Study Type

INTERVENTIONAL

Enrollment

726

Start Date

2021-11-29

Completion Date

2025-03-31

Last Updated

2026-06-26

Healthy Volunteers

Yes

Interventions

COMBINATION_PRODUCT

MenACWY-7B low dose vaccine

MenACWY-7B low dose vaccine is administered intramuscularly in the upper thigh region of the right leg.

COMBINATION_PRODUCT

MenACWY-7B high dose vaccine

MenACWY-7B high dose vaccine is administered intramuscularly in the upper thigh region of the right leg.

COMBINATION_PRODUCT

MenABCWY-1Gen vaccine

MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg.

COMBINATION_PRODUCT

MenB vaccine

MenB vaccine is administered intramuscularly in the upper thigh region of the right leg.

COMBINATION_PRODUCT

MenACWY-TT vaccine

MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg.

Locations (33)

GSK Investigational Site

Santo Domingo Este, Dominican Republic

GSK Investigational Site

Espoo, Finland

GSK Investigational Site

Helsinki, Finland

GSK Investigational Site

Jarvenpaa, Finland

GSK Investigational Site

Kokkola, Finland

GSK Investigational Site

Oulu, Finland

GSK Investigational Site

Seinäjoki, Finland

GSK Investigational Site

Gilching, Germany

GSK Investigational Site

Schönau am Königssee, Germany

GSK Investigational Site

San Pedro Sula, Honduras

GSK Investigational Site

Bydgoszcz, Poland

GSK Investigational Site

Krakow, Poland

GSK Investigational Site

Krakow, Poland

GSK Investigational Site

Luboń, Poland

GSK Investigational Site

Siemianowice Śląskie, Poland

GSK Investigational Site

Torun, Poland

GSK Investigational Site

Trzebnica, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Wroclaw, Poland

GSK Investigational Site

Parow Valley, South Africa

GSK Investigational Site

Soweto Gauteng, South Africa

GSK Investigational Site

Almería, Spain

GSK Investigational Site

Burgos, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Marbella, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Santiago de Compostela, Spain

GSK Investigational Site

Seville, Spain

GSK Investigational Site

Exeter, United Kingdom

GSK Investigational Site

Oxford, United Kingdom