Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2341 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Pneumococcal Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sibling vaccinated with PCV GSK1024850A

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)

PCV GSK1024850A

Intervention Type BIOLOGICAL

2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Control-vaccinated sibling

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)

hepatitis B vaccine or hepatitis A vaccine

Intervention Type BIOLOGICAL

2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Interventions

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PCV GSK1024850A

2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Intervention Type BIOLOGICAL

hepatitis B vaccine or hepatitis A vaccine

2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Intervention Type BIOLOGICAL

Other Intervention Names

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GSK Biologicals' Synflorix TM vaccine GSK Biologicals' Engerix TM (hepatitis B) vaccine GSK Biologicals' Havrix TM (hepatitis A) vaccine

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)

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes