drugset / Trial / NCT02918708

Assessment of Novel Pneumococcal Conjugate Vaccination Scheduled in UK Infants

NCT02918708

RandomizedParallel-groupOpen-labelPrevention

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. The investigators 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).

Timeline

Start
Primary completion
2017-01-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prevnar 13 Vaccine
Comparator Synflorix Vaccine

Indications

No indication recorded.