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: May 28, 2014
Last verified: May 2014
  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 in Older Siblings of Children Vaccinated With Infant Schedules [ Time Frame: one sampling at 3 to 7 years of age ] [ Designated as safety issue: No ]
    Nasopharyngeal 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.


Enrollment: 2341
Study Start Date: April 2011
Estimated Study Completion Date: December 2018
Primary Completion Date: June 2013 (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)

NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children)

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)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: April 2, 2014
Last Updated: May 28, 2014
Health Authority: Finland: Ethics Committee

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

ClinicalTrials.gov processed this record on October 30, 2014