NCT02148328

Safety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults

A Phase 1, Double-blind, Active-controlled, Randomized Study in Healthy Adults to Evaluate Safety, Tolerability, and Immunogenicity of a Trivalent and Quadrivalent Cell-based Virosomal Subunit Influenza Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the safety and tolerability after administration of trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.

Detailed description

This is a double-blind and randomized study in healthy adults. The duration of study will be approximately 90 days per participant. The study will include 4 visits: Day 1 (for vaccination), Day 4, Day 22 and day 90 (Follow-up visits). Safety and tolerability will be assessed by the rate of solicited, unsolicited, and serious adverse events.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent virosomal influenza vaccine	Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
BIOLOGICAL	Commercial vaccine 1	Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
BIOLOGICAL	Quadrivalent virosomal influenza vaccine	Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
BIOLOGICAL	Commercial vaccine 2	Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-05-28
• Last updated: 2014-10-24

Locations

4 sites across 1 country: Belgium