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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Clinical Narratives Request - Cervarix, August 8, 2007

To: Mr. Matthew Whitman
File: STN 125259/0 CERVARIX
RE: Clinical Narratives Request
Date: August 8, 2007

1. Regarding the dataset containing unsolicited AEs in Protocol 015, please provide clinical narratives for the following subjects:

a. Subject #9514 (US) who developed iritis at 136 days postdose 2.
b. Subject #7721 (Canada) who developed kerato-uveitis and decreased visual acuity at 29 days postdose 2.

2. Regarding the dataset containing unsolicited AEs in Protocol 012, please provide a clinical narrative for subject #2870, (Netherlands), who developed keratoconjunctivitis at 21 days postdose 1.

3. Regarding the dataset containing unsolicited AEs in Protocol 016, please provide a clinical narrative for subject #303, (Netherlands), who was diagnosed as having Crohn's disease.