NCT00620815

Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above

A Phase II, Randomized, Placebo-controlled, Observer-blind, Multi Center Study on the Safety and Immunogenicity of Novartis Tetravalent Influenza Vaccine (Containing Both Interpandemic Strains and H5N1) in Adults Aged 18 Years and Above

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine	Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3.
BIOLOGICAL	Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1	Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3.
BIOLOGICAL	Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccine	Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3.
BIOLOGICAL	Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1	Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3.
BIOLOGICAL	Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccine	Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.
BIOLOGICAL	MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine	Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-01-01
• Completion: 2008-12-01
• First posted: 2008-02-22
• Last updated: 2016-03-28
• Results posted: 2012-09-19

Locations

2 sites across 1 country: Germany