PINC trial
Research type
Research Study
Full title
Assessment of antibody responses in UK infants given two doses of 10 or 13 valent pneumococcal conjugate vaccine (PCV) in infancy and PCV13 in the second year of life (study code: Pneumococcal in New Combinations (PINC))
IRAS ID
210806
Contact name
Paul Turner
Contact email
Sponsor organisation
Public Health England
Eudract number
2016-003565-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The National Vaccine Evaluation Consortium conducts Department of Health funded trials trials to provide information to underpin changes to the national immunisation and vaccination schedule.
This study will assess how different schedules of pneumococcal conjugate vaccines work in providing protection to young infants. It is well established that vaccines can behave differently depending on which order they are given and alongside which other immunisations. This has been shown for Hib and MenC vaccines, which are similar in structure to the pneumococcal vaccines that will be studied here. We will measure responses to the pneumococcal vaccines as well as to other routine immunisations, all of which will be provided by our study team. Infants will be recruited by dedicated study staff through primary care and will participate from their first vaccinations at 2 months of age, until the blood sample taken a month after their boosters at a year old, i.e. until 13 months of age.
Any child found to have antibody levels below that which indicates protection for Hib, MenC, MenB or pneumococcal in the blood sample taken at 13 months of age will be offered an extra dose of the relevant vaccine(s).
REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/1926
Date of REC Opinion
22 Nov 2016
REC opinion
Favourable Opinion