C3511002_Phase 2b study_safety and Immunongenicity of MenABCWY
Research type
Research Study
Full title
A Phase 2b, Open-Label Trial to Assess the Safety, Tolerability, and Immunogenicity of MenABCWY in Healthy Infants 2 and 6 Months of Age
IRAS ID
291882
Contact name
Timothy Hall
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2020-000948-60
Duration of Study in the UK
1 years, 7 months, 19 days
Research summary
Meningococcal disease is caused by a germ. There are different types of this germ – meningococcal germ type A, B, C, W and Y. The meningococcal germ can cause disease such as infection of the brain lining (meningitis).
The body naturally makes antibodies to help fight off germs and vaccines can help the body do this. This study is being done to look at some investigational vaccines (not approved by health authorities) that might help the body make antibodies to fight off the meningococcal germ, and to study the safety of these vaccines in infants.
For the UK there is 2 possible groups. After consent, the patient will be randomised into one of the two groups. Group 11 patients will receive MenABCWY and Group 12 patients will receive Bexsero and Nimenrix. Nimenrix and Bexsero are approved by health authorities in Europe but MenABCWY is investigational vaccine (not approved by health authorities) All patients in the UK will be given paracetamol before and after their vaccinations. The use of paracetamol in this study is investigational because although it is used to treat fever and injection site reactions, it is not approved specifically for preventation of fever and injection site reactions after vaccinations.
Patients aged 2 to 6 months are eligible to take part in this study. If this study is successful then it will reduce the amount of vaccines children need to have while ensuring they are still protected from the Meningococcal disease. If they decide to take part the patient will be in the study for 16 months. The patient will have to attend the study site about 5 times (3 vaccination visits and 2 follow up visits) phone visits will also be used in this study. There will be a mixture of GP sites and Hospitals in this study.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0016
Date of REC Opinion
2 Feb 2021
REC opinion
Unfavourable Opinion