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Vaccines

Information in Summary of Clinical Efficacy-Cervarix, May 7, 2007

To: Ms. Sharon Shapowal (GSK)
File: STN #125259
Re: Information in Summary of Clinical Efficacy (Module 2.7.3)
Date: May 7, 2007
Regarding the information included in Summary of Clinical Efficacy (Module 2.7.3), we have the following items:
1. For subjects enrolled in Protocol 008 who had CIN 2+ irrespective of DNA status,
you state that 120 subjects in the HPV group and 112 subjects in the HAV group developed CIN 2+ due to any HPV type while enrolled in the study (Table 31, Page 109). When we performed this analysis, we identified 105 subjects in the HPV group and 95 subjects in the HAV group who developed CIN 2+ due to any HPV type. We request that you provide a list of PID numbers for the subjects in the HPV and HAV groups who developed CIN 2+ due to any HPV type in the study. This information may help to clarify the discrepancy between our results of this analysis. Please respond.
2. We note that there were two subjects in the HPV group and 21 subjects in the HAV group who developed a case of HPV 16- and/or HPV 18-related CIN 2+ (Table 15, Page 86). We request that you provide a list of PID numbers for the subjects in each group who developed HPV 16- and/or HPV-18-related CIN 2+. Additionally, we request that you provide the PID numbers for the three subjects who were not included in the TVC-1/HPV type assignment algorithm analysis (data presented in Table 16, Page 88). Please respond.
Regarding the "epccon: Biopsy results" dataset for Protocol 008 we have the following items:
3. Please indicate the variable used in the dataset to identify study endpoint CIN 2+ cases as assessed by the study pathology panel.
4. We note that information regarding HPV type(s) identified within the CIN 2+ lesion was not provided for several subjects (i.e., for subjects with PID numbers 1154, 1789, 2290, 7729, 12022, 13355, 73735, 85028, 21950, 73982, 12554, 11848, 21108, 15894, 1308, 5985, 13060, 14670, and 15251). We request that you submit results of your analysis to identify HPV type(s) present within the CIN 2+ lesions for these subjects. If the data cannot be provided, we request that you explain why the data are not available.