Overview

This trial is active, not recruiting.

Condition child health
Treatments pneumococcal conjugate vaccine gsk1024850a, hepatitis b vaccine or hepatitis a vaccine
Sponsor Arto Palmu
Collaborator GlaxoSmithKline
Start date April 2011
End date June 2013
Trial size 2341 participants
Trial identifier NCT01311024, THL/1843/6.02.01/2010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
Older sibling of a child vaccinated with PCV 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)
pneumococcal conjugate vaccine gsk1024850a GSK Biologicals' Synflorix TM vaccine
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
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 GSK Biologicals' Engerix TM (hepatitis B) vaccine
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Primary Outcomes

Measure
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
time frame: one sampling at 3 to 7 years of age

Secondary Outcomes

Measure
Carriage Due to Any Pneumococcal Serotype
time frame: one sampling at 3 to 7 years of age
Carriage Due to Haemophilus Influenzae
time frame: one sampling at 3 to 7 years of age
Invasive Pneumococcal Disease
time frame: Up to 8 years
Hospital-diagnosed Pneumonia
time frame: Up to 8 years
Tympanostomy Tube Surgery
time frame: Up to 8 years
Outpatient Antibiotic Treatment
time frame: Up to 8 years

Eligibility Criteria

Male or female participants from 3 years up to 7 years old.

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)

Additional Information

Official title Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study
Principal investigator Arto A Palmu, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by National Institute for Health and Welfare, Finland.