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NCT01689155 · ClinicalTrials.gov registry record
Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children
A clinical trial, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- 116
- Enrollment target
NCT01689155: Completed study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT01689155 is a clinical trial that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 116 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01689155 has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- 116 participants
- Enrollment target
Study Summary
This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the second dose. Observational Objective: * To describe and characterize adverse events occurring after vaccination with Menactra vaccine.
Primary Outcome
Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.
Interventions
- BIOLOGICAL Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-04 |
What the finished NCT01689155 record still lists
NCT01689155 is an observational study that tracks outcomes without assigning an intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate is the first listed.
NCT01689155 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01689155 about?
NCT01689155 is a clinical study titled "Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children". This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the sec...
What is the current status of trial NCT01689155?
This trial is currently completed. The enrollment target is 116 participants. The study started on 2011-06. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01689155?
The interventions under investigation include: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (BIOLOGICAL).
Who is sponsoring clinical trial NCT01689155?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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