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Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

This study has been completed.
Novartis Vaccines
Information provided by:
Novartis Identifier:
First received: May 23, 2006
Last updated: September 13, 2006
Last verified: September 2006
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over

Condition Intervention Phase
Influenza Biological: Surface Antigen, Inactivated, Influenza (form.2006-07) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2006-2007, When Administered to Non-Elderly Adult and Elderly Subjects

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.

Secondary Outcome Measures:
  • Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
  • Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
  • Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

Estimated Enrollment: 100
Study Start Date: June 2006

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

Inclusion Criteria:

  • 18 years of age or older

Exclusion Criteria:

  • any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
  • hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine known or suspected (or high risk of developing) impairment/alteration of
  • immune function within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable)
  • fever within the past 3 days
  • history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
  • within the past 12 months have received more than one injection of influenza vaccine
  • Women who are pregnant or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00329966

Dipartimento di Medicina e Scienze dell’Invecchiamento Università G. D’AnnunzioVia dei Vestini
Chieti, Italy, 66100
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37
Lanciano, Italy
Sponsors and Collaborators
Novartis Vaccines
Study Chair: Novartis Vaccines - Drug Information Services Novartis Vaccines & Diagnostics
  More Information Identifier: NCT00329966     History of Changes
Other Study ID Numbers: V71P4S
Eudract no.2006-000609-43
Study First Received: May 23, 2006
Last Updated: September 13, 2006

Keywords provided by Novartis:

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017