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

NCT00382187 | Completed Phase 2

• 2 other identifiers: V87P2Eudract number 2006-004063-66
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Influenza

Keywords

influenza; pandemic influenza; influenza vaccine; adjuvanted influenza vaccine; H5N1 influenza antigen; MF59; Pandemic influenza disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.

  Day 1 to Day 382

Study Arms (3)

MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms

EXPERIMENTAL

Biological: MF59 adjuvanted H5N1 influenza vaccine

MF59 adjuvant H5N1 influenza vaccine 15 micrograms

EXPERIMENTAL

Biological: MF59 adjuvanted H5N1 influenza vaccine

non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen

EXPERIMENTAL

Biological: MF59 adjuvanted H5N1 influenza vaccine

Interventions

MF59 adjuvanted H5N1 influenza vaccine BIOLOGICAL

* MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1 * non-adjuvanted influenza vaccine containing 15 ug of H5N1

MF59 adjuvant H5N1 influenza vaccine 15 micrograms; MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms; non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female volunteers 18-60 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3

Siena, Siena, 53100, Italy

Location

Related Publications (1)

• Galli G, Medini D, Borgogni E, Zedda L, Bardelli M, Malzone C, Nuti S, Tavarini S, Sammicheli C, Hilbert AK, Brauer V, Banzhoff A, Rappuoli R, Del Giudice G, Castellino F. Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels. Proc Natl Acad Sci U S A. 2009 Mar 10;106(10):3877-82. doi: 10.1073/pnas.0813390106. Epub 2009 Feb 23.

  PMID: 19237568 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Novartis Vaccines - Information Services

  Novartis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 28, 2006
• Study Start: November 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: December 1, 2016

Record last verified: 2012-02

Locations

IT (1)