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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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 ##Subjects483? Classification Inspection
Radiant Research
Austin , Texas
1402187YesVAI
Radiant Research
Cincinnati , Ohio
1408173NoNAI
Radiant Research
Scottsdale , Arizona
1418180NoNAI

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 ##Subjects483? Classification Inspection
Radiant Research
West Palm Beach , Florida
240580YesVAI
Radiant Research
St. Louis , Missouri
2407138YesVAI
Radiant Research
Greer , South Carolina
2412102NoEIR pending
Radiant Research
Santa Rosa , California
241358YesVAI
Radiant Research
Lakewood , Washington
241462YesVAI

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