Indirect 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 indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.

Detailed Description
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The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years. This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2011 and a register-based follow-up study for invasive disease, hospital-diagnosed pneumonia, tympanostomy tube surgery and outpatient antimicrobial treatment.

Official Title
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Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: PCV GSK1024850A
* Biological: hepatitis B vaccine or hepatitis A vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 3 to 7 years younger sibling at least 12 months of age living in the same household participates in the FinIP or 053 trial (regardless of the vaccination schedule) at least one parent with fluent Finnish informed consent from one parent Exclusion Criteria: commercial PCV vaccination administered study-related PCV vaccination administered (open or blind) 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: 7 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 |
| --- | --- |
| Sibling vaccinated with PCV GSK1024850A<br>Older sibling of a child vaccinated with Pneumococcal conjugate vaccine GSK1024850A in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children) | Biological: PCV GSK1024850A<br>* 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)<br>* Other names: GSK Biologicals' Synflorix TM vaccine;|
| Control-vaccinated sibling<br>Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children) | Biological: hepatitis B vaccine or hepatitis A vaccine<br>* 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)<br>* Other names: GSK Biologicals' Havrix TM (hepatitis A) vaccine;|

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) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules | Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age | one sampling at 3 to 7 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carriage Due to Any Pneumococcal Serotype | Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age | one sampling at 3 to 7 years of age | 
| Carriage Due to Haemophilus Influenzae | Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age | one sampling at 3 to 7 years of age | 
| Invasive Pneumococcal Disease | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Up to 8 years | 
| Hospital-diagnosed Pneumonia | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Up to 8 years | 
| Tympanostomy Tube Surgery | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Up to 8 years | 
| Outpatient Antibiotic Treatment | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Up to 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Pneumococcal Vaccines