Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

N/ACompletedNCT01925222

Arto Palmu3,900 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

3,900

Conditions

Nasopharyngeal Carriage of Streptococcus Pneumoniae

Eligibility

Sex: ALLMin age: 3 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

National Institute for Health and Welfare

Tampere, Finland

Outcomes

Primary Outcomes

Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) in children vaccinated in infancy

Nasopharyngeal and oropharyngeal swabs taken once at 3 to 5 years of age

Time frame: one sampling at 3 to 5 years of age

Secondary Outcomes

Carriage due to any pneumococcal serotype in children vaccinated in infancy

Time frame: one sampling at 3 to 5 years of age

Data from ClinicalTrials.gov

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