Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza

Status Completed

Clinical Trial Summary

This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to demonstrate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria. The study will also help to define the optimal dose, establish potential competitive advantages, and support the design of future studies.

Clinical Trial Description

This randomized, observer-blind, multicenter, Phase 2 study will be conducted at multiple sites across the United States and Canada.

The influenza strain composition of the Quadrivalent VLP Vaccine used in this study includes 2 influenza A virus strains (A/California/7/2009 [H1N1] and A/Switzerland/9715293/2013 [H3N2]) and 2 influenza B virus strains (B/Phuket/3073/2013 [Yamagata lineage] and B/Brisbane/60/2008 [Victoria lineage]), based on the 2015-2016 recommended World Health Organization (WHO) strains for vaccination in the Northern hemisphere.

Approximately 900 healthy subjects will be randomized in a 1:1:1 ratio to 1 of 3 parallel treatment groups. Subjects in each group will be stratified into 2 age strata: 18 to 49 years and 50 to 64 years in a 2:1 ratio.

Subjects will receive one intramuscular (IM) injection of their assigned vaccine:

- 15 µg/strain of Quadrivalent VLP Vaccine, or

- 30 µg/strain of Quadrivalent VLP Vaccine, or

- 15 µg/strain of the licensed and commercially available quadrivalent vaccine FluLaval® Tetra.

Subjects will participate in this study for approximately 8 months, during which 5 visits will be scheduled, and phone contact will be made on Day 1, Day 8, and every 2 months thereafter for up to 6 months post-Day 21 visit (Day 201). Safety laboratory assessments will be performed at Screening, on Day 3 and within 48 hours of Day 3 results availability, for grade 3 or grade 4 abnormalities or if deemed necessary by the investigator or early termination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02768805
Study type	Interventional
Source	Medicago
Contact
Status	Completed
Phase	Phase 2
Start date	March 2, 2016
Completion date	November 26, 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms