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A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants
Sponsor: GlaxoSmithKline
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
Conditions
Interventions
MenACWY-7B low dose vaccine
MenACWY-7B low dose vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenACWY-7B high dose vaccine
MenACWY-7B high dose vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenABCWY-1Gen vaccine
MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenB vaccine
MenB vaccine is administered intramuscularly in the upper thigh region of the right leg.
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