Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage (FinIPcarr)

February 3, 2021 updated by: Arto Palmu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

2341

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-PCV-vaccinated 3 to 7 year-old siblings living in the same household with a younger child vaccinated in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Description

Inclusion Criteria:

  • age 3 to 7 years
  • younger sibling at least 12 months of age living in the same household participates in the FinIP or 053 trial (regardless of the vaccination schedule)
  • at least one parent with fluent Finnish
  • informed consent from one parent

Exclusion Criteria:

  • commercial PCV vaccination administered
  • study-related PCV vaccination administered (open or blind)
  • history of antimicrobial treatment within 4 weeks (the child can be enrolled later)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sibling vaccinated with PCV GSK1024850A

Older sibling of a child vaccinated with Pneumococcal conjugate vaccine GSK1024850A in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children)
Biological: PCV GSK1024850A
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Other Names:
  • GSK Biologicals' Synflorix TM vaccine
Control-vaccinated sibling

Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children)
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)
Other Names:
  • GSK Biologicals' Engerix TM (hepatitis B) vaccine
  • GSK Biologicals' Havrix TM (hepatitis A) vaccine

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) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules
Time Frame: one sampling at 3 to 7 years of age
Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
one sampling at 3 to 7 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carriage Due to Any Pneumococcal Serotype
Time Frame: one sampling at 3 to 7 years of age
Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
one sampling at 3 to 7 years of age
Carriage Due to Haemophilus Influenzae
Time Frame: one sampling at 3 to 7 years of age
Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
one sampling at 3 to 7 years of age
Invasive Pneumococcal Disease
Time Frame: Up to 8 years
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Up to 8 years
Hospital-diagnosed Pneumonia
Time Frame: Up to 8 years
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Up to 8 years
Tympanostomy Tube Surgery
Time Frame: Up to 8 years
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Up to 8 years
Outpatient Antibiotic Treatment
Time Frame: Up to 8 years
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arto Palmu

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Arto A Palmu, M.D., Finnish Institute for Health and Welfare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 7, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Actual)

March 1, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THL/1843/6.02.01/2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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