Table of Contents
AVIRON COLD-ADAPTED LIVE ATTENUATED INFLUENZA VIRUS VACCINE, TRIVALENT FLUMIST?
Clinical Review Team
Indication Sought
Studies in Support of Efficacy
Studies in Support of Consistency of Manufacturing
AV006 - Pediatric Efficacy Trial
AV006 Design:Vaccines
AV006 Design: Monitoring for Efficacy
AV006 Design: Endpoints
Results - Year 1 Enrollment
AV006 - Results: Cx Obtained
AV006 - Year 1 Efficacy
AV006 - Year 1: Efficacy
AV006 - Year 1: Efficacy by Age
AV006 - Year 1: Efficacy by Gender and Ethnicity
AV006 - Year 1: Subjects with Illness and Cultures Obtained in 1st 14 Days
AV006 - Year 1: Subjects with Illness and Cultures Obtained in 1st 14 Days
AV006 - Illness Profiles of Subjects with Cxs in 1st 14 Days
Immunogenicity
AV006 - Year 1 Immunogenicity: Strain-specific HAI GMT Results
AV006 - Year 1: GMFR from Pre to Post-Dose 1 or 2 in FluMist? Subjects
AV006 - Year 2
AV006 - Year 2 Efficacy
AV011 - H1N1 Challenge Study
AV011 - Design
AV011 - Efficacy Against Shedding Vaccine CAIV-M (H1N1)
AV009 - Adult Effectiveness Trial
AV009 - Primary Objectives
AV009 - Effectiveness Results
AV009 - Rate of AFI-Assoc. Events
AV003 - Wild-type Influenza Challenge in Adults
AV003 - Design: Definitions
AV003 - Vaccines and Challenge Strains
AV003 - Efficacy Against Laboratory-Documented Influenza Illness
AV007 - Lot Consistency Trial
AV007-Results: Post-Dose 2 HAI GMT Ratios Among Consistency Lots
AV014 - Manufacturing Bridging
AV014 - Post-Dose 2 to Baseline Percent Seroconversion
AV014 - Post-Dose 2 GMT Ratios in All Participants
Efficacy Conclusions
Aviron FluMist? Safety Summary
Safety Monitoring Categories
Studies in Support of Safety - Selected Pediatric Trials
Studies in Support of Safety - Selected Adult Trials
Studies in Support of Safety - Selected Trials in “At-risk” Subjects
First Dose Vaccinees by April 30, 2001
AV009 - Effectiveness in Healthy Adults: Safety Results
AV009 - RE Results by Group
AV009 - Results: Unsolicited “Other” AEs
AV009 - Safety Results
AV006 Safety Monitoring for Years 1, 2 and 3
AV006 Year 1 - Selected REs by Group
AV006 - Year 1 Selected “Other AEs” by Group and Dose
AV006 - Year 2 REs
AV006 - Year 3 [AV015]
AV006 - Year 3 Results
AV006 - Pneumonia Cases
AV019 - SAEs and Medically Attended Events (MAEs)
AV019 - Interim Analysis
AV019 - Interim Results: SAEs
AV019 - Interim Results: MAEs
AV019 - Interim Results: Pneumonia
AV019 - MAEs, Sponsor Assessed as Plausibly Related for FluMist? vs. Placebo (per 1000 person months)
AV012 - Texas Community Study
AV012 - Year 1: SAE and AEs
AV010 - Asthma Study
AV010 - AE Profiles of Subjects
HIV-Infected Adults: Results
VA Study - SAE Reports
Pediatric Pneumonia Cases
Other AEs - Pneumonia
SAEs - Deaths
Safety Conclusions
Additional Concerns
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