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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00391053 |
Compared to young adults, the elderly mount a lower antibody response to vaccination. Thus, improvement of the immune response to influenza vaccination in this age group, which is at higher risk for influenza-related morbidity and mortality, represents an important unmet need.
Primary Objectives:
Immunogenicity:
Secondary Objectives:
Immunogenicity:
Safety:
Condition | Intervention | Phase |
---|---|---|
Orthomyxoviridae Infection Influenza Myxovirus Infection |
Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine Biological: Inactivated, Split-Virion Influenza Vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 3876 |
Study Start Date: | October 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1
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Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM
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2: Experimental
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2
|
Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM
|
3: Experimental
High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3
|
Biological: High-Dose Inactivated, Split-Virion Influenza Vaccine
o.5 mL, IM
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4: Active Comparator |
Biological: Inactivated, Split-Virion Influenza Vaccine
0.5 mL, IM
|
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Continuous use with a dosage equivalent to >15 mg/day of oral prednisone for 90 days preceding vaccination.
Sporadic use with a dosage equivalent to > 40 mg/day of oral prednisone for > 14 consecutive days in the 90 days preceding vaccination.
Note:Use of topical or inhalant corticosteroids is acceptable.
Note:Concomitant participation in an observational trial (not involving drugs, vaccines, or medical devices) is acceptable.
Study Director: | Clinical Trials | sanofi pasteur |
Responsible Party: | Sanofi Pasteur, Inc. ( Medical Monitor ) |
Study ID Numbers: | FIM05 |
Study First Received: | October 20, 2006 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00391053 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Influenza Orthomyxoviruses Inactivated Split-virion influenza vaccine Adults |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases Communicable Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections Infection |