Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage (FinIPcarr)
Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
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Tampere, Finlande
- National Institute for Health and Welfare
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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)
Autres noms:
|
|
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)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Carriage Due to Any Pneumococcal Serotype
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Arto A Palmu, M.D., Finnish Institute for Health and Welfare
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- THL/1843/6.02.01/2010
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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