CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 665 enrolled
Drug / intervention
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated) +4 morebiological
Likely dose
High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated)from record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03698279
NCT03698279Phase 2Completed
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Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 5, 2018·Updated Apr 4, 2022

In Brief

A Phase 2 clinical trial evaluating High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated), High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated), and 3 other interventions for Influenza. Completed, enrolled 665 participants across 16 sites in 2 countries.

Detailed Summary

The objectives of this study were: * To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study). * To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) measurement method. * To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method. * To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 5, 2018
Enrollment StartOct 9, 2018
Primary CompletionOct 16, 2019
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.7 years ago

Interventions

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated)biological

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

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated)biological

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

High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)biological

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

Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated)biological

Pharmaceutical form: Solution for injection Route of administration: IM

FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)biological

Pharmaceutical form: Solution for injection Route of administration: IM