Vaccines, Blood & Biologics
Bioresearch Monitoring Inspection Results - Ixiaro
| Date: | August 27, 2008 |
|---|---|
| From: | Anthony Hawkins, Bioresearch Monitoring, HFM-664 Division of Inspections and Surveillance Office of Compliance and Biologics Quality |
| Through: | Patricia Holobaugh, Bioresearch Monitoring Branch Chief, HFM-664 |
| To: | Lewis Markoff, Chair, BLA Committee, HFM-451 |
| Subject: | Bioresearch Monitoring Inspection Results STN: 125280/0 Product: Japanese Encephalitis Virus Vaccine Inactivated Sponsor: Intercell AG |
SUMMARY STATEMENT
The bioresearch monitoring inspections of eight clinical sites did not reveal problems that impact the data submitted in the application.
BACKGROUND
Eight clinical investigator inspections were performed in support of this Biologics LicenseApplication (BLA). Study subject population, geographic distribution, and field resource considerations were among the factors used to select the inspected sites. Information from the BLA was compared to source documents, during the inspections.
CLINICAL INVESTIGATORS
| Site # | #Subjects | 483? | Classification Inspection | |
|---|---|---|---|---|
| Radiant Research Austin , Texas | 1402 | 187 | Yes | VAI |
| Radiant Research Cincinnati , Ohio | 1408 | 173 | No | NAI |
| Radiant Research Scottsdale , Arizona | 1418 | 180 | No | NAI |
STUDY TITLE:
Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 (JE-PIV) vs. JE-VAX® as Vaccines for Japanese Encephalitis in Healthy Subjects (Study code IC51-301)
CLINICAL INVESTIGATORS, continued
| Site # | #Subjects | 483? | Classification Inspection | |
|---|---|---|---|---|
| Radiant Research West Palm Beach , Florida | 2405 | 80 | Yes | VAI |
| Radiant Research St. Louis , Missouri | 2407 | 138 | Yes | VAI |
| Radiant Research Greer , South Carolina | 2412 | 102 | No | EIR pending |
| Radiant Research Santa Rosa , California | 2413 | 58 | Yes | VAI |
| Radiant Research Lakewood , Washington | 2414 | 62 | Yes | VAI |
STUDY TITLE:
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51 (JE-PIV). Double Blind, Randomized, Placebo Controlled Phase 3 Study
(Study code IC51-302)
SPONSOR ISSUES
No sponsor or monitoring issues were noted.
NOTEWORTHY INSPECTIONAL FINDINGS
There were only a few minor problems noted. Post vaccination discharge time was not adequately documented (30 subjects - Site 1408). Six subjects left the study site before the minimum 60 minutes post vaccination timeframe, or the subjects’ time of departure could not be determined (Site 2414). A phlebotomist administered injections of the study drug or placebo to 11 subjects and she performed study visit procedures and completed case report form entries for 10 subjects; another staff member administered injections of study drug or placebo to eight subjects and she also determined inclusion/ exclusion criteria and entered case report form entries for two subjects. The clinical investigator did not authorize either of the individuals to perform those responsibilities (Site 2407). Six subjects’ electronic case report form entries did not match the information contained within the corresponding source documents including SAE causality and severity criteria, urinalysis test results, concomitant vaccination date, and vital signs (Site 2413).
BIMO ADMINISTRATIVE FOLLOW-UP
We issued inspection closeout letters to sites 1402, 1408, 1418, 2405, 2407, 2413 and 2414. Correspondence will be issued to site 2412 after review of the establishment inspection report and final inspection classification is complete. Please contact me at (301) 827-6338 if you have any questions about this memo or any aspect of bioresearch monitoring.
_____________________
Anthony Hawkins
Consumer Safety Officer
