NCT00812019

Dose Ranging Study to Evaluate Immunogenicity and Safety of Adjuvanted or Non-adjuvanted Cell Culture-derived H5N1 Influenza Vaccine in Young Adults (18-40 Years Old)

A Phase I/II, Randomized, Observer-blind, Multicenter, Dose Ranging Study to Evaluate the Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted or Non-Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine in Healthy Subjects 18 - 40 Years of Age.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 753 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The aim of the present dose ranging study is to evaluate the safety, tolerability and immunogenicity of two doses of twelve different formulations of a Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine, adjuvanted with MF59 or non-adjuvanted, given three weeks apart and followed by a booster dose after 12 months in healthy adults 18 to 40 years of age.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59	Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 0% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59	Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 25% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59	Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 50% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59	Two vaccinations of Cell Culture-Derived H5N1 3.75 µg Subunit Influenza Vaccine containing 100% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59	Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 0% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59	Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 25% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59	Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 50% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59	Two vaccinations of Cell Culture-Derived H5N1 7.5 µg Subunit Influenza Vaccine containing 100% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59	Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 0% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59	Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59	Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59.
BIOLOGICAL	Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59	Two vaccinations of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-03-01
• Completion: 2010-11-01
• First posted: 2008-12-19
• Last updated: 2020-08-24

Locations

2 sites across 2 countries: United States, Germany