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COMPLETED 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

NCT05050318 · View on ClinicalTrials.gov ↗

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

43 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05050318

The ClinicalTrials.gov registry entry for NCT05050318 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05050318 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Kentucky, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05050318?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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