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Assess the Safety & Immunogenicity of Prime-Boost Vaccination Strategies Using H5Nx Virus Vaccine Adjuvanted With AS03 or MF59

NCT03497845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2020-07-14

Study results available
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Summary

The main purpose of this study is to assess the ability of H5 influenza virus vaccines and adjuvants present in the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) to generate an immune response to homologous and to antigenically distant heterologous H5 influenza virus strains.

The study is designed to evaluate the safety and immunogenicity of vaccination strategies with homologous or antigenically distant heterologous H5 influenza virus vaccines administered with AS03 or MF59 adjuvant.

Conditions

  • Influenza A Virus, H5N1 Subtype

Interventions

BIOLOGICAL

VN

0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

BIOLOGICAL

IN

0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

BIOLOGICAL

dk/BANG

0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

BIOLOGICAL

gf/WA

0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

BIOLOGICAL

bhg/QL

0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

BIOLOGICAL

AS03 adjuvant

0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

BIOLOGICAL

MF59 adjuvant

0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-15
Primary Completion
2019-11-19
Completion
2019-11-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03497845 on ClinicalTrials.gov