N/A
N=2,341
Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT01311024 ↗Enrolled (actual)
2,341
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: 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 percentage of subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PCV GSK1024850A (Biological); hepatitis B vaccine or hepatitis A vaccine (Biological)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Arto Palmu
- Primary completion
- Jun 2013
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 |
— | — |
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.
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.