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| Sponsor: | Novartis |
|---|---|
| Collaborator: |
Novartis Vaccines |
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00841763 |
Purpose
The present study, phase III, randomized, controlled, observer-blind, multicenter study, will evaluate safety, tolerability and immunogenicity of two doses of an adjuvanted monovalent influenza vaccine compared with an adjuvanted interpandemic trivalent influenza vaccine in a population of ealthy adult and elderly subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Pandemic Influenza Disease |
Biological: Interpandemic adjuvanted trivalent influenza vaccine Biological: Investigational adjuvanted monovalent influenza vaccine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | A Phase III, Randomized, Controlled, Observer-blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine in Adult and Elderly Subjects |
| Enrollment: | 3647 |
| Study Start Date: | October 2008 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Investigational adjuvanted monovalent influenza vaccine
Investigational adjuvanted monovalent influenza vaccine + 1 dose of non-adjuvanted trivalent seasonal influenza vaccine
|
| Active Comparator: 2 |
Biological: Interpandemic adjuvanted trivalent influenza vaccine
Interpandemic adjuvanted trivalent influenza vaccine + 1 dose of placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
In good health as determined by:
Exclusion Criteria:
Known or suspected impairment/alteration of immune function, for example, resulting from:
Contacts and Locations| Finland | |
| Tampere Vaccine Research Clinic (15 sites) | |
| Tampere, Finland, 33100 | |
| Germany | |
| 20 Sites | |
| München, Germany, 80799 | |
| Study Chair: | Novartis Vaccines | Novartis Vaccines |
More Information
| Responsible Party: | Novartis, Novartis Vaccines |
| ClinicalTrials.gov Identifier: | NCT00841763 History of Changes |
| Other Study ID Numbers: | V87P13, 2008-003871-32 |
| Study First Received: | February 10, 2009 |
| Last Updated: | January 7, 2010 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
|
virus pandemic influenza vaccine |
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |