Phase IV randomisation study of different Men B vaccine primary immunisation schedules in UK infants.
Status: Closed to Recruitment
Disease group: Meningococcal B
Sponsor: St George’s, University of London
Principal Investigator: Prof. Paul Heath
This study is being done to compare two different primary immunisation schedules for Meningococcal B disease (MenB) in infants. UK Infants will either complete the primary MenB schedule by 4 months, as usual, or earlier, by 3 months. We will then measure their immune responses to either the standard or early schedule. This could provide infants earlier protection against MenB disease since cases peak at 5 months of age and remain high in the second half of the first year. If this clinical trial shows no difference in immune response for the main 4CMenB antigens using the two different schedules, then the results could change UK national immunisation policy to offer infants earlier protection against this devastating disease and could potentially be adopted by other countries worldwide.
What does participating in the study involve?
Infants who take part in the study will receive all recommended vaccines according to the standard UK schedule until the age of 1 years old. They will be randomly assigned (like tossing a coin) to one of two groups: Group 1 will receive all recommended vaccines, with a slight adjustment to the order – the second dose of Men B vaccine at 3 instead of 4 months and the first dose of pneumococcal (PCV13) at 4 instead of 3 months. Group 2 (control group) will receive all recommended vaccines according to the standard UK schedule. In order to compare the vaccines responses of infants in the 2 groups, a blood sample will be collected on 3 occasions: Once after the primary vaccinations and again before and after the booster vaccinations at 1 years old. Families will be asked to complete a diary card after each set of vaccinations. The diary card will be used to record daily temperatures and any redness or swelling that may occur around the injection site, for up to 7 days after each vaccination. The duration of the study will be 13 months from start to finish.
St George’s is very proud to be leading this important study. There are 5 other hospitals in the UK taking part and hundreds of babies and families are taking part.
For more information on the study please contact the study team: email@example.com