MENACWY = MEN7B-003
Research type
Research Study
Full title
A Phase II, randomised, partially blinded study to assess the safety, tolerability and immunogenicity of meningococcal combined ABCWY vaccine when administered to healthy infants.
IRAS ID
303652
Contact name
Nicola Butterworth
Contact email
Sponsor organisation
GlaxoSmithKline Ltd
Eudract number
2021-001367-24
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Invasive meningococcal disease (IMD) is caused by a germ called neisseria meningitidis. IMD can cause meningitis or sepsis which can be serious, sometimes causing death. Ninety percent (90%) of meningococcal meningitis and septicaemia infections are caused by only 5 types of this germ (A, B, C, W, Y).
This study, funded by GSK, will look at the safety, tolerance and body’s response to 2 types of a combination vaccine in infants that may protect against all 5 types of this germ.
Study part 1 will include 40 infants in 3 countries, 1 UK site will take part. Study part 2 will include 648 infants worldwide, 5 UK sites will take part.
Whichever study part the infant enters, infants (accompanied by their parent/guardian) will have up to 5 study visits and receive a dose of the vaccine (or a control vaccine) at 2, 4 & 12 months old. Infants will have a medical history taken, 4 physical exams (including temperature), 3 blood samples, and ongoing safety follow up. Their parent/guardian will complete 8 questionnaires on their child's health on an electronic device. Infants’ parent/guardian will also have 3 phone visits.
Infants will be closely observed by a medical professional for 30 mins post-dose for safety. They will also be given all usual routine childhood vaccinations.
The infant’s duration in the study will be approximately 16 months.An independent data monitoring committee will check safety data throughout the study.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0296
Date of REC Opinion
27 Sep 2021
REC opinion
Favourable Opinion