NCT01311024

Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,341 (actual)
• Sponsor: Arto Palmu · Other Government
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pneumococcal Infections

Interventions

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

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-06-01
• Completion: 2017-12-01
• First posted: 2011-03-09
• Last updated: 2021-03-01
• Results posted: 2014-05-05

Locations

1 site across 1 country: Finland