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Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine

OverviewStructured DataIssuesContributors

Contents

clinicaltrials.gov/study/NCT04961541
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT049615410
Health Conditions in Trial
‌
covid19
0
Trial Recruitment Size
6420
Trial Sponsor
Novavax
Novavax
0
Clinical Trial Start Date
September 8, 2021
0
Primary Completion Date
December 22, 2021
0
Study Completion Date
April 22, 2022
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Biological0
Intervention Name
SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant0
qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant0
ICC Vaccine0
Interventional Trial Phase
Phase 20
Phase 10
Participating Facility
University of the Sunshine Coast
University of the Sunshine Coast
0
‌
Emeritus Research
0
Official Name
A Phase 1/2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a Quadrivalent Hemagglutinin Nanoparticle Influenza and SARS-CoV-2 rS Nanoparticle Combination Vaccine With Matrix M1™ Adjuvant in Healthy Participants ≥ 50 to ≤ 70 Years of Age0
Last Updated
July 22, 2022
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Triple0
Masked Party
Investigator0
Care Provider0
Participant0
Study summary

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine.

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