Study to evaluate conjugate MenACYW vaccine in the UK infant schedule
Research type
Research Study
Full title
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers when Administered Using a 1+1 Schedule in a National Immunization Schedule Having a Meningococcal Group B Vaccine as Standard of Care
IRAS ID
243476
Contact name
Prof Adam Finn
Contact email
Sponsor organisation
Sanofi Pasteur Inc.
Eudract number
2017-004520-30
Clinicaltrials.gov Identifier
Not Applicable, Not Applicable
Duration of Study in the UK
2 years, 8 months, 19 days
Research summary
In this study, healthy infants of about 2 months of age will receive an investigational meningococcal vaccine called MenACYW conjugate vaccine, alongside the routine childhood vaccines recommended in the UK for infants and toddlers. The MenACYW conjugate vaccine is not yet licensed for use in the United Kingdom (UK) or elsewhere. The MenACYW conjugate vaccine is being developed to protect people of all ages against meningococcal disease caused by four common types of meningococci, A, C, W, and Y. Meningococcal disease is a rare but serious illness that can occur at any age. It can present as meningitis (infection of the covering of the brain and spinal cord), blood poisoning (septicaemia), or pneumonia. The aim of the study is to show whether or not the immune response to the MenACYW conjugate vaccine is as strong as needed to protect against meningococcal disease caused by 4 types of meningococcal bacteria, A, C, W and Y. Furthermore, the study is assessing the safety of the MenACYW conjugate vaccine and the safety of the routine childhood vaccines when these are given together. During the study, children will be vaccinated on the same schedule as the normal childhood vaccinations, at 2, 3, 4 and 12 months of age. Four in five of the children taking part in the study will be assigned by chance to receive, in addition to the routine vaccines, two doses of the investigational MenACYW conjugate vaccine, one at 3 months of age, and another one at 12 months of age. Blood samples will be collected before and after receiving the MenACYW conjugate vaccine in order to evaluate the immune response to vaccination. A total of about 700 children are planned to take part in the study. The study consist of 5 study visits plus 4 interim follow-up phone calls over an approximate 12 month period.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0223
Date of REC Opinion
5 Jul 2018
REC opinion
Further Information Favourable Opinion