Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: MF59 adjuvanted H5N1 influenza vaccine

• Registration Number: NCT00382187
• Lead Sponsor: Novartis Vaccines

Brief Summary

The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, and a 6 month booster dose, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, and of a non-adjuvanted influenza vaccine containing 15 micrograms of H5N1 influenza antigen, in adults

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-27
• Study First Submitted QC: 2006-09-27
• Study First Posted: 2006-09-28
• Study Start: 2006-11
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2012-02
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male and female volunteers 18-60 years of age

Exclusion Criteria

• Any auto-immune disease or other serious acute, chronic or progressive disease
• Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine
• History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
• Within the past 7 days, they have experienced any acute disease or infections requiring systemic antibiotic or antiviral therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms	MF59 adjuvanted H5N1 influenza vaccine	-
non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen	MF59 adjuvanted H5N1 influenza vaccine	-
MF59 adjuvant H5N1 influenza vaccine 15 micrograms	MF59 adjuvanted H5N1 influenza vaccine	-

Primary Outcome Measures

Name	Time	Method
CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination.	day 1 to day 43

Secondary Outcome Measures

Name	Time	Method
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.	Day 1 to Day 382

Trial Locations

Locations (1)

Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3; 🇮🇹 Siena, Italy