- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00240877
Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
November 19, 2008 updated by: MedImmune LLC
A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a Monovalent Vaccine of a New 6:2 Reassortant in Healthy Adults (AV024)
To assess the safety of a vaccine in healthy adults prior to the release of the trivalent vaccine (FluMist).
Study Overview
Detailed Description
The primary study objective is to assess the safety of a monovalent vaccine of a new 6:2 reassortant in healthy adults prior to the release of the trivalent vaccine (FluMist).
Safety will be demonstrated by similar fever rates (oral temperature ≥101°F) in vaccine and placebo recipients.
Study Type
Interventional
Enrollment (Actual)
330
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33181
- SFBC International Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-64 years of age (not yet reached their 65th birthday);
- In good health;
- Available by telephone;
- Ability to understand and comply with the requirements of the protocol; and
- Signed informed consent.
Exclusion Criteria:
- Any condition, other than age, for which the inactivated influenza vaccine is indicated, including: chronic disorders of the pulmonary or cardiovascular systems, including asthma; chronic metabolic diseases (including diabetes mellitus) renal dysfunction, or hemoglobinopathies which required regular medical follow-up or hospitalization during the proceeding year;
- Acute febrile (>100.0°F oral) illness or clinically significant respiratory illness within the 14 days prior to enrollment;
- Hypersensitivity to egg or egg protein;
- Signs or symptoms of any immunosuppressive or immune deficiency disease, including HIV infection, or ongoing immunosuppressive therapy; or an immunosuppressed individual living in the same household;
- Participation in another investigational trial within one month prior to enrollment or expected enrollment in another investigational trial during this study; and
- Any condition that in the opinion of the investigator, might interfere with the vaccine evaluation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
Placebo mist consisting of normal allantoic fluid.
0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
|
Experimental: 1
Monovalent vaccine prior to the release of the trivalent vaccine (FluMist).
|
0.5 mL total dose volume administered intranasal by spray applicator (approximately 0.25 mL into each nostril).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
- The primary endpoint of this study is fever defined as oral temperature ≥101°F
Time Frame: Days 0-7
|
Days 0-7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All other reported reactogenicity events and other adverse events.
Time Frame: After 7 days after vaccination
|
After 7 days after vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2002
Primary Completion (Actual)
August 1, 2003
Study Completion (Actual)
April 1, 2004
Study Registration Dates
First Submitted
October 14, 2005
First Submitted That Met QC Criteria
October 14, 2005
First Posted (Estimate)
October 18, 2005
Study Record Updates
Last Update Posted (Estimate)
November 20, 2008
Last Update Submitted That Met QC Criteria
November 19, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- AV024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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