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NCT04460781 · ClinicalTrials.gov registry record
Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring
A clinical trial of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- 96,175
- Enrollment target
- 1
- Study location
NCT04460781 is a study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 96,175 participants, above the 36,187-participant average among 156 other Influenza trials with a reported enrollment target (166% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04460781, a study of Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- 96,175 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective: To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28 days preceding the estimated date of conception with regards to pregnancy, birth, and neonatal/infant outcomes Secondary Objective:
Conditions Studied
Interventions
- BIOLOGICAL Flublok Quadrivalent influenza vaccine RIV4
- BIOLOGICAL Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4
Study Locations (1)
California
- Kaiser Permanente Northern California - Oakland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96,175 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2022-02-28 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04460781
The ClinicalTrials.gov registry entry for NCT04460781 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 96,175 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 36,187-participant average among 156 other Influenza trials with a reported enrollment target (166% higher). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Flublok Quadrivalent influenza vaccine RIV4 is the first listed.
NCT04460781 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04460781 about?
NCT04460781 is a clinical study titled "Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring". Primary Objective: To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up to 28 days preceding the estimated date of conception with regards to pregnancy, birth, and neonatal/...
What is the current status of trial NCT04460781?
This trial is currently completed. The enrollment target is 96,175 participants. The study started on 2018-09-17. Estimated completion is 2022-02-28.
What conditions does trial NCT04460781 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT04460781?
The interventions under investigation include: Flublok Quadrivalent influenza vaccine RIV4 (BIOLOGICAL), Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04460781?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04460781 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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