NCT01925222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

3.3 years

First QC Date

August 15, 2013

Last Update Submit

March 29, 2017

Conditions

Nasopharyngeal Carriage of Streptococcus Pneumoniae

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Carriage due to any pneumococcal serotype in children vaccinated in infancy

    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

    one sampling at 5 to 9 years of age

Study Arms (5)

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

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Health and Welfare

Tampere, 33520, Finland

Location

Related Publications (1)

  • 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.

    PMID: 23158882BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal and oropharyngeal swabs

Study Officials

  • Arto A Palmu, MD, PhD

    Finnish Institute for Health and Welfare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research manager

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 19, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

FI(1)