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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00111579 |
The purpose of this study is to describe the level of serum antibody conferred by CAIV-T and TIV against homotypic and heterotypic influenza virus strains.
Condition | Intervention | Phase |
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Influenza |
Biological: CAIV-T Other: TIV |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety Study |
Official Title: | A Prospective, Randomized, Open-Label Study to Evaluate the Immune Responses of Trivalent Cold-Adapted Influenza Vaccine (CAIV-T) Compared With Trivalent Inactivated Vaccine (TIV) in Children 6 to <36 Months of Age |
Estimated Enrollment: | 52 |
Study Start Date: | May 2005 |
Study Completion Date: | January 2006 |
Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
CAIV-T
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Biological: CAIV-T
A total vol. of 0.2 mL will be administered intranasally (approx. 0.1 mL into each nostril)for ea. of two doses.
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2
TIV
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Other: TIV
A total vol. of 0.25 will be administered intramuscularly for each of two doeses.
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Ages Eligible for Study: | 6 Months to 36 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Utah | |
Bear Care Pediatrics | |
Ogden, Utah, United States, 84405 | |
Wee Care Pediatrics | |
Layton, Utah, United States, 84041 | |
Families First Pediatrics | |
South Jordan, Utah, United States, 84095 | |
Alpine Pediatrics | |
Pleasant Grove, Utah, United States, 84062 | |
Utah Valley Pediatrics | |
Provo, Utah, United States, 84604 |
Study Director: | Robert Walker, MD | MedImmune LLC |
Responsible Party: | MedImmune LLC ( Chris Ambrose, Dir. Medical Affairs ) |
Study ID Numbers: | MI-CP123 |
Study First Received: | May 23, 2005 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00111579 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |