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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
  Purpose

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


Condition Intervention Phase
Influenza
 Biological: MF59 adjuvanted H5N1 influenza vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Bird Flu Flu
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: November 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms 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 15 micrograms 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: non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382187

Locations
Italy
Presidio Distrettuale N. 8, Azienda USL 7 di Siena, Via Savina Petrilli, 3
Siena, Italy, 53100
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines - Information Services Novartis
  More Information

Publications:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00382187     History of Changes
Other Study ID Numbers: V87P2, Eudract number 2006-004063-66
Study First Received: September 27, 2006
Last Updated: February 12, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Novartis:
influenza
pandemic influenza
influenza vaccine
adjuvanted influenza vaccine
 H5N1 influenza antigen
MF59
Pandemic influenza disease

Additional relevant MeSH terms:
Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013