CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04109222
NCT04109222Phase 4Completed
CompareCT.gov

Collection of Serum Samples From Children 6 Months to < 9 Years of Age Who Received Fluzone® Quadrivalent and Adults ≥ 65 Years of Age Who Received Fluzone® High-Dose, Influenza Vaccines, 2019-2020 Formulations

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 30, 2019·Updated Sep 12, 2025

In Brief

A Phase 4 clinical trial evaluating Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation and Fluzone High-Dose vaccine, 2019-2020 formulation for Influenza. Completed, enrolled 90 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedSep 30, 2019
Enrollment StartSep 30, 2019
Primary CompletionDec 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.8 years ago

Interventions

Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulationbiological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Fluzone High-Dose vaccine, 2019-2020 formulationbiological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular