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Paediatric Post Pneumococcal Conjugate Vaccine Nasopharyngeal Carriage Study

NCT04401488 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2020-05-29

No results posted yet for this study

Summary

The investigators intend to investigate the carriage of pneumococci and other respiratory microbes since the introduction of pneumococcal conjugate vaccines (Prevenar 7 and Prevenar 13). The principal aim is to gain a collection of samples that can be used to help investigate any changes that might occur in the epidemiology of microbes that are carried in the upper respiratory tract and which may cause respiratory disease, sepsis or meningitis after the introduction of Prevenar.

Nasopharyngeal and nasal swabs will be taken from up to 2,000 children aged 4 years and under in each year of the study. Swabs will be processed using traditional microbiology and molecular diagnostic techniques and isolated microbes such as S. pneumoniae further characterised using molecular methods. The investigators will also ask parents to complete a short questionnaire requesting: basic demographic data; vaccine history; recent illness; overseas travel and antibiotic usage.

The study will contribute to the success of the introduction of pneumococcal conjugate vaccines and will play a central role in maintaining confidence. The study will also help provide information for future vaccine policy as further vaccines are developed against microbes which cause respiratory disease, sepsis and meningitis.

Conditions

  • S. Pneumoniae
  • Pneumococcal Conjugate Vaccine

Interventions

BIOLOGICAL

Prevenar 7 and Prevenar 13

pneumococcal conjugate vaccines

Sponsors & Collaborators

  • Solent NHS Trust

    collaborator OTHER_GOV

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Eligibility

Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2022-03-31
Completion
2022-03-31
FDA Drug
Yes

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 NCT04401488 on ClinicalTrials.gov