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Assessment of Novel Pneumococcal Conjugate Vaccination Scheduled in UK Infants

NCT02918708 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-08-28

No results posted yet for this study

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).

Conditions

  • Vaccination
  • Immunization

Interventions

BIOLOGICAL

Synflorix

10-valent pneumococcal conjugate vaccine

BIOLOGICAL

Prevenar13

13-valent pneumococcal conjugate vaccine

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Institute of Child Health

    collaborator OTHER

  • Public Health England

    lead OTHER_GOV

Principal Investigators

  • Elizabeth Coates, PhD · Public Health England

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Primary Completion
2017-01-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02918708 on ClinicalTrials.gov