Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

Completed

• Conditions: Nasopharyngeal Carriage of Streptococcus Pneumoniae

• Registration Number: NCT01925222
• Lead Sponsor: Arto Palmu

Brief Summary

The purpose of this study is to assess the direct effects of the ten-valent pneumococcal conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.

These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011.

Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder non-vaccinated siblings aged 5 to 9 years.

Detailed Description

This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2013 from vaccinated and unvaccinated children.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-19
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3900

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) in children vaccinated in infancy	one sampling at 3 to 5 years of age	Nasopharyngeal and oropharyngeal swabs taken once at 3 to 5 years of age

Secondary Outcome Measures

Name	Time	Method
Carriage due to any pneumococcal serotype in children vaccinated in infancy	one sampling at 3 to 5 years of age

Trial Locations

Locations (1)

National Institute for Health and Welfare; 🇫🇮 Tampere, Finland