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| Sponsor: | MedImmune LLC |
|---|---|
| Information provided by: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00192491 |
Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: FluMist Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Randomized, Placebo-Controlled, Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (FluMist) and Measles, Mumps, Rubella, (MMRIIÒ) and Varicella (VARIVAXÒ) Vaccines Administered Concurrently to Healthy Children (AV018) |
| Estimated Enrollment: | 1200 |
| Study Start Date: | December 2000 |
| Study Completion Date: | December 2003 |
| Estimated Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
FluMist
|
Biological: FluMist
Nasal sprayer of FluMist
|
|
Placebo Comparator: 3
Placebo
|
Other: Placebo
Nasal Sprayer of Placebo
|
|
Active Comparator: 1
FluMist with other solution
|
Biological: FluMist
Nasal Sprayer of one dosage of FluMist and other experimental
|
Eligibility| Ages Eligible for Study: | 12 Months to 15 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Robert Walker, M.D., MedImmune Inc. |
| ClinicalTrials.gov Identifier: | NCT00192491 History of Changes |
| Other Study ID Numbers: | AV018 |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 7, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Chickenpox Influenza, Human Herpesviridae Infections DNA Virus Infections Virus Diseases |
Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Infections Respiratory Tract Diseases |