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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01311024
Other study ID # THL/1843/6.02.01/2010
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2011
Est. completion date December 2017

Study information

Verified date February 2021
Source Finnish Institute for Health and Welfare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 2341
Est. completion date December 2017
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 7 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
PCV GSK1024850A
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
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)

Locations

Country Name City State
Finland National Institute for Health and Welfare Tampere

Sponsors (2)

Lead Sponsor Collaborator
Arto Palmu GlaxoSmithKline

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary Invasive Pneumococcal Disease Register follow-up up to 8 years after the vaccination of the younger sibling in the family Up to 8 years
Secondary Hospital-diagnosed Pneumonia Register follow-up up to 8 years after the vaccination of the younger sibling in the family Up to 8 years
Secondary Tympanostomy Tube Surgery Register follow-up up to 8 years after the vaccination of the younger sibling in the family Up to 8 years
Secondary Outpatient Antibiotic Treatment Register follow-up up to 8 years after the vaccination of the younger sibling in the family Up to 8 years
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