NCT05082285 - A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants | Biotech Hunter

Enrollment

724

Participants

Timeline

Start Date

November 29, 2021

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions

Infections, Meningococcal

Interventions

COMBINATION_PRODUCT

MenABCWY-2Gen low dose vaccine

MenABCWY-2Gen low dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and study Part II.

COMBINATION_PRODUCT

MenABCWY-2Gen high dose vaccine

MenABCWY-2Gen high dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 2 and study Part II.

COMBINATION_PRODUCT

MenABCWY-1Gen vaccine

MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part II.

COMBINATION_PRODUCT

MenB vaccine

MenB vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.

COMBINATION_PRODUCT

MenACWY-TT vaccine

MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.

Trial Locations (33)

2013

GSK Investigational Site, Soweto Gauteng

7505

GSK Investigational Site, Parow Valley

15706

GSK Investigational Site, Santiago de Compostela

21101

GSK Investigational Site, San Pedro Sula

28040

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28222

GSK Investigational Site, Madrid

29004

GSK Investigational Site, Málaga

29600

GSK Investigational Site, Marbella

41013

GSK Investigational Site, Seville

50368

GSK Investigational Site, Wroclaw

60100

GSK Investigational Site, Seinäjoki

67100

GSK Investigational Site, Kokkola

82205

GSK Investigational Site, Gilching

83471

GSK Investigational Site, Schönau am Königssee

90220

GSK Investigational Site, Oulu

Unknown

GSK Investigational Site, Santo Domingo Este

02230

GSK Investigational Site, Espoo

00100

GSK Investigational Site, Helsinki

04400

GSK Investigational Site, Järvenpää

85-048

GSK Investigational Site, Bydgoszcz

30-348

GSK Investigational Site, Krakow

30-644

GSK Investigational Site, Krakow

62-030

GSK Investigational Site, Luboń

41-103

GSK Investigational Site, Siemianowice Śląskie

87-100

GSK Investigational Site, Torun

55-100

GSK Investigational Site, Trzebnica

02-647

GSK Investigational Site, Warsaw

04120

GSK Investigational Site, Almería

09006

GSK Investigational Site, Burgos

EX2 5DW

GSK Investigational Site, Exeter

OX3 7LE

GSK Investigational Site, Oxford