Skip to main content
OpenTrials
Completed

NCT Number: NCT01925222

Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

The purpose of this study is to assess the direct effects of the ten-valent pneumococcal conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.

These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011.

Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder non-vaccinated siblings aged 5 to 9 years.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nasopharyngeal Carriage of Streptococcus Pneumoniae

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute for Health and Welfare

Tampere, 33520, Finland

About this study

This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2013 from vaccinated and unvaccinated children.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for FinIP-vaccinated children:

  • age 3 to 5 years
  • enrolled in the FinIP trial and has received at least one dose of study vaccine in the infant vaccine schedule (3+1 or 2+1)
  • at least one parent with fluent Finnish
  • informed consent from one parent

Exclusion criteria

for FinIP-vaccinated children

  • PCV vaccination administered, other than the randomized study vaccine
  • history of antimicrobial treatment within 4 weeks (the child can be enrolled later)

Inclusion criteria

for unvaccinated siblings

  • age 5 to 9 years
  • younger sibling living in the same household having participated in the FinIP trial (regardless of the vaccination schedule)
  • at least one parent with fluent Finnish
  • informed consent from one parent

Exclusion criteria

for unvaccinated siblings

  • PCV vaccination administered
  • history of antimicrobial treatment within 4 weeks (the child can be enrolled later)

Treatment and study plan

Primary outcomes

  1. Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) in children vaccinated in infancy

    Time frame: one sampling at 3 to 5 years of age

    Nasopharyngeal and oropharyngeal swabs taken once at 3 to 5 years of age

Secondary outcomes

  1. Carriage due to any pneumococcal serotype in children vaccinated in infancy

    Time frame: one sampling at 3 to 5 years of age

Other outcomes

  1. Carriage due to any pneumococcal serotype included in the PCV vaccine in unvaccinated older siblings of the PCV10-vaccinated children

    Time frame: one sampling at 5 to 9 years of age

Sponsors and collaborators

Lead sponsor

Arto Palmu

Other Gov

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study During PCV National Vaccination Programme

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 19, 2013
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.