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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
500
Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid
Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid
Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid
Trivalent Dose; intramuscular injection, deltoid
Preconfigured dose; intramuscular injection, deltoid
CMAX
Adelaide, Australia
Emeritus Research
Melbourne, Australia
Linear Clinical Research
Perth, Australia
Holdsworth House
Sydney, Australia
Immunogenicity of 3 dose levels of the Novavax Quadrivalent vaccine based on HAI responses
Time frame: Day 21
Number of Solicited and Unsolicited Adverse Events for the Novavax Quadrivalent vaccine
Time frame: 6 months
Estimate capacity of the Novavax Quadrivalent vaccines to fulfill FDA criteria (immunogenicity) for all strains in healthy, young adults
Based on criteria of greater than or equal to 40% HAI seroconversion and greater than or equal to 70% of subjects with HAI titers greater than or equal to 1:40 post-vaccination.
Time frame: Day 21
Impact of including a fourth strain in the Novavax Quadrivalent vaccine on immune responses to other three strains
Based on comparison to a trivalent NovaFlu formulation tested at the 22.5ug of HA (per strain) dose level.
Time frame: Day 21
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.