Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage (FinIPcarr)
Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Tampere, Finland
- National Institute for Health and Welfare
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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) |
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov
Identifier:NCT00861380)
Andra namn:
|
|
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) |
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov
Identifier:NCT00861380)
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Carriage Due to Any Pneumococcal Serotype
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Arto A Palmu, M.D., Finnish Institute for Health and Welfare
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- THL/1843/6.02.01/2010
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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