Overview

This trial is active, not recruiting.

Condition nasopharyngeal carriage of streptococcus pneumoniae
Sponsor Arto Palmu
Collaborator GlaxoSmithKline
Start date August 2013
End date December 2016
Trial size 3900 participants
Trial identifier NCT01925222, FinIP-carriage13THL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm

Primary Outcomes

Measure
Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) in children vaccinated in infancy
time frame: one sampling at 3 to 5 years of age

Secondary Outcomes

Measure
Carriage due to any pneumococcal serotype in children vaccinated in infancy
time frame: one sampling at 3 to 5 years of age

Eligibility Criteria

Male or female participants from 3 years up to 9 years old.

Inclusion Criteria for FinIP-vaccinated children: 1. age 3 to 5 years 2. enrolled in the FinIP trial and has received at least one dose of study vaccine in the infant vaccine schedule (3+1 or 2+1) 3. at least one parent with fluent Finnish 4. informed consent from one parent Exclusion criteria for FinIP-vaccinated children 1. PCV vaccination administered, other than the randomized study vaccine 2. history of antimicrobial treatment within 4 weeks (the child can be enrolled later) Inclusion criteria for unvaccinated siblings 1. age 5 to 9 years 2. younger sibling living in the same household having participated in the FinIP trial (regardless of the vaccination schedule) 3. at least one parent with fluent Finnish 4. informed consent from one parent Exclusion criteria for unvaccinated siblings 1. PCV vaccination administered 2. history of antimicrobial treatment within 4 weeks (the child can be enrolled later)

Additional Information

Official title Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study During PCV National Vaccination Programme
Principal investigator Arto A Palmu, MD, PhD
Description This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2013 from vaccinated and unvaccinated children.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by National Institute for Health and Welfare, Finland.