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Vaccines, Blood & Biologics

8/14/2008 Email

From: Daemer, Richard J.
Sent: Thursday, August 14, 2008 2:55 PM
To: 'Paul WILSON'
Cc: Markoff, Lewis; Niu, Manette; Roberts, Jeff; Tiernan, Rose (CBER); Miller, Daryll L
Subject: PVP Comments
Comments to the Sponsor:

1. Please provide a detailed statistical analysis plan. Please provide justification for the sample size of 10,000 subjects. In general, we would like to see at least a 20,000 subject post-marketing general safety study. The study will need sufficient power to detect a doubling or tripling of serious, rare events. Please specify the predefined AEFI that you plan to follow and explain why those endpoints were chosen. Please provide an exploratory component to the cohort analyses which would identify all AE FI (i.e., not only predetermined AEFI) more common after IXIARO®.

2. Please provide a copy of the neurologic AEFI questionnaire.

3. Will the vaccine be licensed for use in elderly individuals? If so, please provide safety data for this age group. The post marketing study may need to be tiered to include a certain number of individuals who are 70-79 and 80 or older.

4. Please provide the rationale for limiting temporal association of AEFI to 7 or 28 days after vaccination. Please consider using a risk window of 42 days.

5. Please provide the rationale for classifying hypotension and circulatory collapse under the Tier 2 (not expected to be serious) AEFI.

6. In addition to relying on the spontaneous reporting of pregnancies, please provide a plan in which the DMSS database is monitored for pregnancies in female service members who receive JEV vaccine. In the event that the female service member receives JEV vaccine during pregnancy or the pregnancy begins <= 3 months after last dose of JEV, please have these individuals followed-up with the pregnancy questionnaire, and their newborns followed up through the third month of the life. Will health data on the newborns, through the completed third month of life, be included in the Pregnancy questionnaire?

7. Please provide a copy of the Pregnancy questionnaire.

8. Please comment if the subjects who will serve as their own control in the retrospective cohort study will be matched by age and gender?

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