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.
Sponsor:
Novartis
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00329966
First received: May 23, 2006
Last updated: September 13, 2006
Last verified: September 2006
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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 and over
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Surface Antigen, Inactivated, Influenza (form.2006-07) |
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 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:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329966
Locations
| Italy | |
| 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
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines - Drug Information Services | Novartis Vaccines & Diagnostics |
More Information
No publications provided
| ClinicalTrials.gov 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 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Novartis:
|
Influenza adult elderly 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 22, 2013