Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

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

Official Title
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Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study During PCV National Vaccination Programme

Conditions
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Nasopharyngeal Carriage of Streptococcus Pneumoniae

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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCV-vaccinated infant, 3+1 schedule<br> | |
| PCV-vaccinated infant, 2+1 schedule<br> | |
| Control-vaccinated infant<br> | |
| PCV-vaccinated child, catch-up schedule<br> | |
| Control-vaccinated child, catch-up schedule<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | one sampling at 3 to 5 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carriage due to any pneumococcal serotype in children vaccinated in infancy |  | one sampling at 3 to 5 years of age |