Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
- Conditions
- Pneumococcal Infections
- Registration Number
- NCT01311024
- Lead Sponsor
- Arto Palmu
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2341
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
Name Time Method Invasive Pneumococcal Disease Up to 8 years Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Carriage Due to Any Pneumococcal Serotype 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
Outpatient Antibiotic Treatment Up to 8 years Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Hospital-diagnosed Pneumonia Up to 8 years Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Tympanostomy Tube Surgery Up to 8 years Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Carriage Due to Haemophilus Influenzae 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
Trial Locations
- Locations (1)
National Institute for Health and Welfare
🇫🇮Tampere, Finland
National Institute for Health and Welfare🇫🇮Tampere, Finland