Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage (FinIPcarr)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Arto Palmu, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT01311024
First received: March 7, 2011
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Child Health
Biological: Pneumococcal conjugate vaccine GSK1024850A
Biological: hepatitis B vaccine or hepatitis A vaccine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study

Resource links provided by NLM:


Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine [ Time Frame: one sampling at 3 to 7 years of age ] [ Designated as safety issue: No ]
    Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age


Secondary Outcome Measures:
  • Carriage due to any pneumococcal serotype [ Time Frame: one sampling at 3 to 7 years of age ] [ Designated as safety issue: No ]
    Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age

  • Carriage due to Haemophilus influenzae [ Time Frame: one sampling at 3 to 7 years of age ] [ Designated as safety issue: No ]
    Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age

  • Invasive pneumococcal disease [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    Register follow-up up to 8 years after the vaccination of the younger sibling in the family

  • Hospital-diagnosed pneumonia [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    Register follow-up up to 8 years after the vaccination of the younger sibling in the family

  • Tympanostomy tube surgery [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    Register follow-up up to 8 years after the vaccination of the younger sibling in the family

  • Outpatient antibiotic treatment [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    Register follow-up up to 8 years after the vaccination of the younger sibling in the family


Biospecimen Retention:   Samples Without DNA

Nasopharyngeal and oropharyngeal swabs obtained.


Estimated Enrollment: 2400
Study Start Date: April 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PCV-vaccinated sibling (GSK1024850A)
Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Biological: Pneumococcal conjugate vaccine GSK1024850A
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Other Name: 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)
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311024

Locations
Finland
National Institute for Health and Welfare
Tampere, Helsinki, Turku, Oulu and Kuopio, Finland
Sponsors and Collaborators
Arto Palmu
GlaxoSmithKline
Investigators
Principal Investigator: Arto A Palmu, M.D. National Institute for Health and Welfare, Finland
  More Information

Additional Information:
No publications provided

Responsible Party: Arto Palmu, Head of Clinical Research Unit, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT01311024     History of Changes
Other Study ID Numbers: THL/1843/6.02.01/2010
Study First Received: March 7, 2011
Last Updated: August 15, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by National Institute for Health and Welfare, Finland:
Children
Pneumococcal Vaccines

ClinicalTrials.gov processed this record on April 16, 2014