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COMPLETED Phase 4

Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively

NCT04109222 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of the study was to provide sera (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.

Conditions Studied

Interventions

  • BIOLOGICAL Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation
  • BIOLOGICAL Fluzone High-Dose vaccine, 2019-2020 formulation

Study Locations (2)

Kentucky

  • Investigational Site Number 8400002 — Bardstown

Utah

  • Investigational Site Number 8400001 — Salt Lake City

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2019-09-30
Est. Completion 2019-12-10
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 NCT04109222

The ClinicalTrials.gov registry entry for NCT04109222 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 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions — of which Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 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: NCT04109222 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 NCT04109222 about?

NCT04109222 is a clinical study titled "Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively". The primary objective of the study was to provide sera (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Center...

What is the current status of trial NCT04109222?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2019-09-30. Estimated completion is 2019-12-10.

What conditions does trial NCT04109222 study?

This clinical trial studies the following conditions: Influenza. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04109222?

The interventions under investigation include: Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation (BIOLOGICAL), Fluzone High-Dose vaccine, 2019-2020 formulation (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04109222?

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 NCT04109222 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