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A(H7N9) VLP Antigen Dose-Ranging Study With Matrix-M1™ Adjuvant

NCT02078674 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 610

Last updated 2016-09-23

No results posted yet for this study

Summary

This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise \~67% of subjects in each treatment group, and the balance will comprise subjects 50 to 64 years.

Each subject will receive two identical IM doses of test article at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.

Conditions

  • Influenza (Pandemic)

Interventions

BIOLOGICAL

Monovalent Avian Influenza VLP (H7N9)

BIOLOGICAL

Matrix-M1™ adjuvant

BIOLOGICAL

Placebo

Sponsors & Collaborators

Principal Investigators

  • D. Nigel Thomas, Ph. D. · Novavax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02078674 on ClinicalTrials.gov