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A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy Young Adults

NCT01561768 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2013-07-18

No results posted yet for this study

Summary

The purpose of this study is to determine the immune response of three dose levels of the Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5 treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group 1-3 will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will receive a dose of the Novavax Trivalent vaccine, and Group 5 will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Novavax Quadrivalent vaccine.

Conditions

Interventions

BIOLOGICAL

Novavax Quadrivalent vaccine

Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid

BIOLOGICAL

Novavax Quadrivalent vaccine

Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid

BIOLOGICAL

Novavax Quadrivalent vaccine

Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid

BIOLOGICAL

Novavax Trivalent vaccine

Trivalent Dose; intramuscular injection, deltoid

BIOLOGICAL

cTIV

Preconfigured dose; intramuscular injection, deltoid

Sponsors & Collaborators

Principal Investigators

  • Nigel Thomas, Ph.D. · Novavax

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
2012-03-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Australia

Study Locations

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Entities

Diseases
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 NCT01561768 on ClinicalTrials.gov