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Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults

NCT03321968 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1202

Last updated 2023-08-04

Study results available
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Summary

This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.

Conditions

  • Virus Diseases
  • RNA Virus Infections
  • Respiratory Tract Infections
  • Respiratory Tract Disease
  • Influenza

Interventions

BIOLOGICAL

Quadrivalent VLP Influenza Vaccine

Single dose of 30 µg/strain Quadrivalent VLP Influenza Vaccine

Sponsors & Collaborators

  • Medicago

    lead INDUSTRY

Principal Investigators

  • Medical Director · Medicago

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-29
Primary Completion
2017-12-01
Completion
2017-12-01
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03321968 on ClinicalTrials.gov