Trial intelligence / Profile preview

Phase IIIB extension study of FLUAD vs Agrippal S1 in previously vaccinated children

2010-021644-18Phase 3Completed

Sponsor
Novartis
Start
Jul 2010
Modality
Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Countries
1
01

Overview

Phase 3, randomised, single-blind trial in influenza comparing FLUAD with Agrippal S1 (2 arms). Primary endpoints: Immunogenicity per CHMP criteria in FLUAD-primed children receiving FLUAD booster, Immunogenicity per CBER criteria in FLUAD-primed children receiving FLUAD booster and 1 more. Started Jul 2010; status: completed.

02

Drugs

Fluzone Trivalentinfluenza vaccine, inactivated, surface antigen
03

Conditions

influenza

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