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NCT05050318 · ClinicalTrials.gov registry record · Phase 4

Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively

A Phase 4 study of Healthy Volunteers and Influenza Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 4
Development phase
90
Enrollment target
2
Study locations

NCT05050318 is a Phase 4 study of Healthy Volunteers and Influenza Immunization that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 90 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT05050318, a Phase 4 study of Healthy Volunteers and Influenza Immunization, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 4
Development phase
90 participants
Enrollment target
2
Study locations

Study Summary

This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (\<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (\>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection process.

Interventions

  • BIOLOGICAL Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation
  • BIOLOGICAL Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation

Study Locations (2)

Kentucky

  • Investigational Site Number :8400001 - Bardstown

Utah

  • Investigational Site Number :8400002 - Salt Lake City

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2021-09-08
Est. Completion 2021-11-10
Phase Phase 4

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

What the Registry Record Tells You About NCT05050318

The ClinicalTrials.gov registry entry for NCT05050318 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (81% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation is the first listed.

NCT05050318 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Kentucky, Utah.

Frequently Asked Questions

What is clinical trial NCT05050318 about?

NCT05050318 is a clinical study titled "Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively". This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (\<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (\>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for s...

What is the current status of trial NCT05050318?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2021-09-08. Estimated completion is 2021-11-10.

What conditions does trial NCT05050318 study?

This clinical trial studies the following conditions: Healthy Volunteers, Influenza Immunization.

What interventions are being tested in trial NCT05050318?

The interventions under investigation include: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation (BIOLOGICAL), Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation (BIOLOGICAL).

Who is sponsoring clinical trial NCT05050318?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05050318 being conducted?

This trial has 2 study locations across Kentucky, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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