Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

Arto Palmu

Status: Completed

Conditions: Nasopharyngeal Carriage of Streptococcus Pneumoniae

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01925222

FinIP-carriage13THL

Details and patient eligibility

About

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.

Full description

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

Enrollment: 3,900 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for FinIP-vaccinated children:

1. age 3 to 5 years
2. 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)
3. at least one parent with fluent Finnish
4. informed consent from one parent

Exclusion criteria for FinIP-vaccinated children

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

Inclusion criteria for unvaccinated siblings

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

Exclusion criteria for unvaccinated siblings

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

Trial design

3,900 participants in 5 patient groups

PCV-vaccinated infant, 3+1 schedule

PCV-vaccinated infant, 2+1 schedule

Control-vaccinated infant

PCV-vaccinated child, catch-up schedule

Control-vaccinated child, catch-up schedule