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

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ClinicalTrials.gov Identifier: NCT00382187
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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

Condition or disease Intervention/treatment Phase
Influenza Biological: MF59 adjuvanted H5N1 influenza vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2006
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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. [ Time Frame: day 1 to day 43 ]

Secondary Outcome Measures :
  1. Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Throughout the Study. [ Time Frame: Day 1 to Day 382 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00382187     History of Changes
Other Study ID Numbers: V87P2
Eudract number 2006-004063-66
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: February 2012

Keywords provided by Novartis ( Novartis Vaccines ):
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
Vaccines
MF59 oil emulsion
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic