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NCT01199016 · ClinicalTrials.gov registry record
Effect of Prevnar 13 on Ear Infections in Children
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 239
- Enrollment target
NCT01199016: Completed study, sponsored by Pfizer.
NCT01199016 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 239 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01199016 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 239 participants
- Enrollment target
Study 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.
Primary Outcome
MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.
Interventions
- PROCEDURE Tympanocentesis
- BIOLOGICAL Observational
- PROCEDURE Nose/throat swab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2010-09 |
| Est. Completion | 2016-01 |
What the finished NCT01199016 record still lists
NCT01199016 is an observational study that tracks outcomes without assigning an intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Tympanocentesis is the first listed.
NCT01199016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01199016 about?
NCT01199016 is a clinical study titled "Effect of Prevnar 13 on Ear Infections in Children". 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 observ...
What is the current status of trial NCT01199016?
This trial is currently completed. The enrollment target is 239 participants. The study started on 2010-09. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01199016?
The interventions under investigation include: Tympanocentesis (PROCEDURE), Observational (BIOLOGICAL), Nose/throat swab (PROCEDURE).
Who is sponsoring clinical trial NCT01199016?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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