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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: Completed study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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:
Primary Outcome
Pregnancy outcome events: spontaneous abortion, preterm labor, stillbirth/Fetal death, congenital/fetal anomalies detected during pregnancy, eclampsia, and placental abruption
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 |
What the finished NCT04460781 record still lists
NCT04460781 is an observational study that tracks outcomes without assigning an intervention. Its 96,175 participants enrollment target places it among the larger protocols in the corpus, above the 36,187-participant average among 156 other Influenza trials with a reported enrollment target (166% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04460781's enrollment target sits among peer trials
96,175 7th of 156 higher than 150 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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