AVIRON COLD-ADAPTED LIVE ATTENUATED INFLUENZA VIRUS VACCINE, TRIVALENT FLUMIST?

8/15/01


Click here to start


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

Author: CBER