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NCT01128426 · ClinicalTrials.gov registry record
Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 53,902
- Enrollment target
NCT01128426: Completed study, sponsored by Pfizer.
NCT01128426 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 53,902 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01128426 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 53,902 participants
- Enrollment target
Study Summary
The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.
Primary Outcome
Relative risk for given event=incidence rate(risk window)/incidence rate(self-control window).Relative risk in inpatient health care setting for pre-dose 1 assessed by comparing incidence rate of reported events in inpatient setting/1000 person-months occurring within 30 days after Dose 1(30-day risk window) with self-control period occurring during 30 days before Dose 1(pre-vaccination 30-day self-control window).Relative risk,exact 2-sided 90 percent (%) confidence intervals (CIs) reported. Me
Interventions
- OTHER No Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53,902 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-06 |
What the finished NCT01128426 record still lists
NCT01128426 is an observational study that tracks outcomes without assigning an intervention. Its 53,902 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which No Intervention is the first listed.
NCT01128426 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01128426 about?
NCT01128426 is a clinical study titled "Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers". The purpose of the study is to expand the understanding of the safety profile of 13vPnC in routine use following licensure and introduction of the vaccine.
What is the current status of trial NCT01128426?
This trial is currently completed. The enrollment target is 53,902 participants. The study started on 2010-06. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01128426?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT01128426?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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