Submission Type: BLA Submission ID: 125296/0 Office: OVRR
Adenovirus Vaccine Live Oral Type 4 and Type 7
Teva Women's Health, Inc.
Telecon Date/Time: 22-Feb-2011 01:02 PM Initiated by FDA? Yes
1. Information Request
Author: DARYLL MILLER
Information Request - Fever as a solicited adverse event
FDA Participants: None
Non-FDA Participants: None
Trans-BLA Group: No
Related STNs: None
Related PMCs: None
From: Gemignani, Helen S
Sent: Tuesday, February 22, 2011 1:02 PM
To: 'Valerie Mulligan'; 'firstname.lastname@example.org'
Subject: Information Request - Fever
As we progress with the review of the Package Insert for the Adenovirus Type 4 and Type 7 Vaccine, Live, Oral, we have noted the absence of fever as a solicited adverse event. Please address the following issues, via email and subsequent amendment:
1. Please provide the location, in the BLA submission, of the subject diaries for the Phase 3 study DR ADV-301. If they were not submitted to the BLA, please send an electronic copy by e-mail and also submit them to the BLA with your next amendment.
2. Please comment on whether the subjects were asked about fever as a solicited adverse event during the study.
3. If fever was included as a solicited adverse event, please provide your rationale as to why it was not included in the PI, section 6.1, under Solicited Adverse Reactions, and also please add appropriate references of fever to the PI.
4. Please comment on whether the data for fever was included in the data set.
5. Please provide your definition of "fever" used in this study. We note that febrile ARD was defined as having a temperature of > 100.5 degrees F.
Helen Sullivan Gemignani
Regulatory Project Manager
Division of Vaccines and Related Products Applications/Regulatory Review Branch 2