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NCT04843111 · ClinicalTrials.gov registry record
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
A clinical trial of Meningococcal Infection, sponsored by Sanofi Pasteur, a Sanofi Company.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT04843111: Recruiting study of Meningococcal Infection, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04843111 is a study of Meningococcal Infection that is actively recruiting participants, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 50 participants, below the 736-participant average among 3 other Meningococcal Infection trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04843111, a study of Meningococcal Infection, is actively recruiting participants, sponsored by Sanofi Pasteur, a Sanofi Company.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
Primary Outcome
Maternal adverse events defined as any reported adverse event (AE), following vaccination of a pregnant woman, occurring independent of the pregnancy (e.g., injection site reactions)
Conditions Studied
Interventions
- BIOLOGICAL Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
Study Locations (1)
Pennsylvania
- Pennsylvania Locations - Swiftwater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-03-05 |
| Est. Completion | 2028-05-18 |
What NCT04843111 shows while recruiting
NCT04843111 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 736-participant average among 3 other Meningococcal Infection trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Meningococcal Infection appearing as the primary indexed condition, and to 1 intervention - of which Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine is the first listed.
NCT04843111 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04843111 about?
NCT04843111 is a clinical study titled "Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)". Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
What is the current status of trial NCT04843111?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2021-03-05. Estimated completion is 2028-05-18.
What conditions does trial NCT04843111 study?
This clinical trial studies the following conditions: Meningococcal Infection.
What interventions are being tested in trial NCT04843111?
The interventions under investigation include: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04843111?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04843111 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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