N/A
Completed N=2,341
Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
Pneumococcal Infections
Source: ClinicalTrials.gov NCT01311024 ↗
Enrolled (actual)
2,341
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: 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 — 14.5; 19.3 percentage of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
14.5; 19.3 | — |
| SECONDARY Carriage Due to Any Pneumococcal Serotype |
— | — |
| SECONDARY Carriage Due to Haemophilus Influenzae |
— | — |
| SECONDARY Invasive Pneumococcal Disease |
— | — |
| SECONDARY Hospital-diagnosed Pneumonia |
— | — |
| SECONDARY Tympanostomy Tube Surgery |
— | — |
| SECONDARY Outpatient Antibiotic Treatment |
— | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01311024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.