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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00382187
First received: September 27, 2006
Last updated: February 12, 2012
Last verified: February 2012
History of Changes

September 27, 2006
February 12, 2012
November 2006
January 2008   (final data collection date for primary outcome measure)
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. [ Time Frame: day 1 to day 43 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00382187 on ClinicalTrials.gov Archive Site
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study. [ Time Frame: Day 1 to Day 382 ] [ Designated as safety issue: Yes ]
Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study.
Not Provided
Not Provided
 
Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults
A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Influenza
Biological: MF59 adjuvanted H5N1 influenza vaccine
  • 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
  • Experimental: MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms
    Intervention: Biological: MF59 adjuvanted H5N1 influenza vaccine
  • Experimental: MF59 adjuvant H5N1 influenza vaccine 15 micrograms
    Intervention: Biological: MF59 adjuvanted H5N1 influenza vaccine
  • Experimental: non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen
    Intervention: Biological: MF59 adjuvanted H5N1 influenza vaccine
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. Epub 2009 Feb 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00382187
V87P2, Eudract number 2006-004063-66
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines - Information Services Novartis
Novartis
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP