Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00518726
First received: August 20, 2007
Last updated: November 14, 2011
Last verified: November 2011
  Purpose

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged > 18 years


Condition Intervention Phase
Influenza
Biological: Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Surface Antigen, Inactivated, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and immunogenicity of seasonal inactivated, influenza vaccine, formulation 2007-2008, when administered to non-elderly adult and elderly subjects

Enrollment: 125
Study Start Date: June 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Biological: Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008
seasonal influenza vaccine 15ug

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 history of neurological symptoms or signs, or anaphylactic shock following administration of any 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 fever within the past 3 days.No women in breast feeding.
  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 ClinicalTrials.gov identifier: NCT00518726

Locations
Italy
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
Via dei Vestini, Chieti, Italy
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto sede legale
Via S. Spaventa, 37, Lanciano, Chieti, Italy
Presidio Distrettuale No. 8 Azienda Sanitaria USL 7 di Siena
Siena, Italy, 53100
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00518726     History of Changes
Other Study ID Numbers: V71P5S, 2007-000963-28
Study First Received: August 20, 2007
Last Updated: November 14, 2011
Health Authority: Italy: Ministero Della Salute, EMEA

Keywords provided by Novartis:
Adjuvanted Influenza Vaccine

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

ClinicalTrials.gov processed this record on July 22, 2014