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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2013 from vaccinated and unvaccinated children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCV-vaccinated infant, 3+1 schedule | |||
| PCV-vaccinated infant, 2+1 schedule | |||
| Control-vaccinated infant | |||
| PCV-vaccinated child, catch-up schedule | |||
| Control-vaccinated child, catch-up schedule |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Carriage due to any pneumococcal serotype in children vaccinated in infancy | one sampling at 3 to 5 years of age |
| Measure | Description | Time Frame |
|---|---|---|
| Carriage due to any pneumococcal serotype included in the PCV vaccine in unvaccinated older siblings of the PCV10-vaccinated children | one sampling at 5 to 9 years of age |
Inclusion Criteria for FinIP-vaccinated children:
Exclusion criteria for FinIP-vaccinated children
Inclusion criteria for unvaccinated siblings
Exclusion criteria for unvaccinated siblings
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Children vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011 and their unvaccinated older siblings.
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| Name | Affiliation | Role |
|---|---|---|
| Arto A Palmu, MD, PhD | Finnish Institute for Health and Welfare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Health and Welfare | Tampere | 33520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23158882 | Background | Palmu AA, Jokinen J, Borys D, Nieminen H, Ruokokoski E, Siira L, Puumalainen T, Lommel P, Hezareh M, Moreira M, Schuerman L, Kilpi TM. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet. 2013 Jan 19;381(9862):214-22. doi: 10.1016/S0140-6736(12)61854-6. Epub 2012 Nov 16. |
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Nasopharyngeal and oropharyngeal swabs