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:
Novartis Vaccines
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
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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:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
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
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 May 19, 2013