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Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage (FinIPcarr)

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ClinicalTrials.gov Identifier: NCT01311024
Recruitment Status : Active, not recruiting
First Posted : March 9, 2011
Results First Posted : May 5, 2014
Last Update Posted : October 16, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Arto Palmu, National Institute for Health and Welfare, Finland

Brief Summary:
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 or disease Intervention/treatment
Pneumococcal Infections Biological: PCV GSK1024850A Biological: hepatitis B vaccine or 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.


Study Type : Observational
Actual Enrollment : 2341 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study
Study Start Date : April 2011
Actual Primary Completion Date : June 2013
Estimated Study Completion Date : December 2018


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 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Biospecimen Retention:   Samples Without DNA
Nasopharyngeal and oropharyngeal swabs obtained.


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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: March 9, 2011    Key Record Dates
Results First Posted: May 5, 2014
Last Update Posted: October 16, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs