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NCT04109222 · ClinicalTrials.gov registry record · 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
A Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 90
- Enrollment target
- 2
- Study locations
NCT04109222: Completed Phase 4 study of Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04109222 is a Phase 4 study of Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 90 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04109222, a Phase 4 study of Influenza, 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
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.
Primary Outcome
Blood samples were collected from participants before first vaccination at Visit 1 (Day 0; pre-vaccination) and at Day 28 after final vaccination either at Visit 2 (Visit 1 + 28 days) for participants who received 1 dose of influenza vaccine; or at Visit 3 (Visit 2 + 28 days) for participants who received 2 doses of influenza vaccine as recommended by ACIP. Collected blood samples were provided to Center for Biologics Evaluation and Research (CBER) for further analysis by World Health Organizati
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
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2019-12-10 |
| Phase | Phase 4 |
What the finished NCT04109222 record still lists
NCT04109222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
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.
NCT04109222 reports a single indexed study location in Kentucky, Utah.
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.
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).
Who is sponsoring clinical trial NCT04109222?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT04109222's enrollment target sits among peer trials
90 105th of 156 higher than 51 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults
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Bone Marrow and Peripheral Blood Immune Responses Study
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Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine
COMPLETED · Phase 4
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A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age
COMPLETED · Phase 4
-
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine
COMPLETED · Phase 4
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