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Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects

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ClinicalTrials.gov Identifier: NCT00311480
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : March 13, 2007
Novartis Vaccines
Information provided by:

Brief Summary:
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.

Condition or disease Intervention/treatment Phase
Pandemic Influenza Disease Biological: Influenza vaccine surface antigen adjuvanted with MF59 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase II, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 7.5 mg or 15 mg of H5N1 Influenza Antigen, in Non-Elderly Adult and Elderly Subjects
Study Start Date : March 2006

Resource links provided by the National Library of Medicine

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

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

Secondary Outcome Measures :
  1. Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Male and female volunteers 18 years of age or older

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, 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): NCT00311480

G. D'Annunzio University
Chieti, Italy, 66100
Department of Health Sciences
Genoa, Italy, 16129
ASL Lanciano-Vasto
Lanciano, Italy, 66034
University Hospital of Siena
Siena, Italy, 53100
Sponsors and Collaborators
Novartis Vaccines
Principal Investigator: Drug Information Services Novartis Vaccines & Diagnostics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00311480     History of Changes
Other Study ID Numbers: V87P1
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: March 13, 2007
Last Verified: March 2007

Keywords provided by Novartis:
pandemic influenza
influenza vaccine
adjuvanted influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
MF59 oil emulsion
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic