CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 90 enrolled
Drug / intervention
Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 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/NCT04551677
NCT04551677Phase 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 Quadrivalent, Influenza Vaccines, 2020-2021 Formulations

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 16, 2020·Updated Sep 12, 2025

In Brief

A Phase 4 clinical trial evaluating Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation and Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation for Influenza Immunization and Healthy Volunteers. Completed, enrolled 90 participants across 2 sites.

Detailed Summary

Primary Objective: To provide serum samples (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines. In addition, serum samples from adult participants may be further analyzed by the Sponsor to assess breadth of immune response induced by the study vaccines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Immunization, Healthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedSep 16, 2020
Enrollment StartSep 16, 2020
Primary CompletionDec 18, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.8 years ago

Interventions

Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulationbiological

Pharmaceutical form: Suspension for injection in a pre-filled syringe, Route of administration: Intramuscular (IM)

Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulationbiological

Pharmaceutical form: Suspension for injection in a pre-filled syringe, Route of administration: IM