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

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.

Study Overview

• Status: Completed
• Conditions: Nasopharyngeal Carriage of Streptococcus Pneumoniae

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 3900

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33520
    • National Institute for Health and Welfare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011 and their unvaccinated older siblings.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Arto Palmu
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Arto A Palmu, MD, PhD, Finnish Institute for Health and Welfare

Publications and helpful links

General Publications

• Palmu AA, Jokinen J, Borys D, Nieminen H, Ruokokoski E, Siira L, Puumalainen T, Lommel P, Hezareh M, Moreira M, Schuerman L, Kilpi TM. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet. 2013 Jan 19;381(9862):214-22. doi: 10.1016/S0140-6736(12)61854-6. Epub 2012 Nov 16. Erratum In: Lancet. 2013 May 18;381(9879):1720. Lancet. 2015 May 30;385(9983):2152.

Helpful Links

• Public webpage for the FinIP trial and the carriage study

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 15, 2013
• First Submitted That Met QC Criteria: August 15, 2013
• First Posted (Estimate): August 19, 2013

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal
• Other Study ID Numbers: FinIP-carriage13THL