N/A
N=239
Effect of Prevnar 13 on Ear Infections in Children
Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT01199016 ↗Enrolled (actual)
239
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM) — 7.5 percentage of MEF samples
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tympanocentesis (Procedure); Nose/throat swab (Procedure); Observational (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM) |
7.5 | — |
Summary
Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar. It is expected that the effectiveness of Prevnar 13 against ear infections in children will be similar to that observed following Prevnar. Pfizer has committed to conduct a postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.
Eligibility Criteria
Inclusion Criteria
- Subject has received full (3-dose) infant series of Prevnar 13
Exclusion Criteria
- Prior vaccination with any 7vPnC.
- Prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vPS).
- Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.
Data sourced from ClinicalTrials.gov (NCT01199016). 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.