Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01925222

Enrollment

3900

Registered

2013-08-19

Start date

2013-08-31

Completion date

2016-12-31

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carriage of Streptococcus Pneumoniae

Brief summary

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

3 Years to 9 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) in children vaccinated in infancy	one sampling at 3 to 5 years of age	Nasopharyngeal and oropharyngeal swabs taken once at 3 to 5 years of age

Secondary

Measure	Time frame
Carriage due to any pneumococcal serotype in children vaccinated in infancy	one sampling at 3 to 5 years of age

Other

Measure	Time frame
Carriage due to any pneumococcal serotype included in the PCV vaccine in unvaccinated older siblings of the PCV10-vaccinated children	one sampling at 5 to 9 years of age

Countries

Finland

Outcome results