A Phase 2 Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Immunogenicity and SAfety of Quadrivalent Seasonal Virus-Like Particle (VLP) Influenza Vaccine (Recombinant) in Healthy Young (18-49) Adults

NCT02307851 Phase 2 COMPLETED

The purpose of this study is to determine the immune response of three dose levels of the Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.

Details

Lead sponsor	Novavax
Phase	Phase 2
Status	COMPLETED
Enrolment	400
Start date	2014-11
Completion	2015-06

Conditions

• Influenza

Interventions

• Quadrivalent VLP Vaccine
• Comparator TIV

Primary outcomes

• Immunogenicity of the quadrivalent VLP vaccine using HAI responses. — Up to 6 months
  Derived/calculated endpoints based on: Seroconversion rate (SCR) Seroprotection rate (SPR) Geometric mean titer (GMT) Geometric mean ratio (GMR)
• Safety of three quadrivalent VLP vaccine formulations. adverse events, Medically Attended Events (MAEs), Serious Adverse Events (SAEs), and Significant New medical Conditions (SNMCs) — Up to 6 months
  Number and percentage of subjects with solicited local and systemic adverse events over the seven days post-injections; all adverse events (including adverse changes in clinical laboratory parameters) over 21 days post-injections; and Medically Attended Events (MAEs), Serious Adverse Events (SAEs), and Significant New medical Conditions (SNMCs) through six months.

Countries

United States