Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study of Healthy Volunteers and Influenza Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples were collected from participants at first vaccination at Visit 1 (Day 1; 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 Organization (
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2021-11-10 |
| Phase | Phase 4 |
What the finished NCT05050318 record still lists
NCT05050318 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 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (81% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
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 NCT05050318's enrollment target sits among peer trials
90 83rd of 283 higher than 201 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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
-
Effects of Energy Drinks on Cardiovascular Endpoints
RECRUITING · Phase 4
-
KarXT Concentrations in the Breast Milk and Plasma of Lactating Females
RECRUITING · Phase 4
-
Investigation of the Gut Microbiome and Statin Response
ACTIVE NOT RECRUITING · Phase 4
-
Thorough QT Study of Nelfinavir
COMPLETED · Phase 4
-
A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age
COMPLETED · Phase 4
-
Adaptive Optics Retinal Imaging
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI