Rapporteurs

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Day 150 Joint Response Assessment Report

Clinical

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 Assessment of the responses to the CHMP List of Questions Gardasil 9 International non-proprietary name: Human Papillomavirus Type 6 L1 protein Human Papillomavirus Type 11 L1 protein Human Papillomavirus Type 16 L1 protein Human Papillomavirus Type 18 L1 protein Human Papillomavirus Type 31 L1 protein Human Papillomavirus Type 33 L1 protein Human Papillomavirus Type 45 L1 protein Human Papillomavirus Type 52 L1 protein Human Papillomavirus Type 58 L1 protein Procedure no. EMEA/H/C/3852 Applicant: Sanofi Pasteur MSD SNC

 

Rapporteur:

Kristina Dunder (SE)

 Co-Rapporteur:

Jan Mueller- Berghaus (DE)

Start of the procedure:

2014-03-26

Date of this report:

2014-11-25

Deadline for comments:

2014-12-08

 

LIST OF ABBREVIATIONS

9vHPV vaccine Nine-valent Human Papillomavirus vaccine AE Adverse experience AIN Anal intraepithelial neoplasia AIS Adenocarcinoma in situ ANSS All (HPV Type-specific) Naïve Subjects with Serology ASC-H Atypical squamous cells cannot rule out HSIL ASC-US Atypical squamous cells of undetermined significance CI Confidence interval CIN Cervical intraepithelial neoplasia cLIA Competitive Luminex Immunoassay CRF Case report form DSMB Data and Safety Monitoring Board EGLs External genital lesions ELISA Enzyme-linked immunosorbent assay FAS Full Analysis Set GMR Geometric mean ratio GMTs Geometric Mean Titres HN-TS HPV-Naïve Type-Specific HPV Human Papillomavirus HR High-risk HSIL High-Grade Squamous Intraepithelial Lesion LR Low-risk MSM Men who have sex with men Pap Papanicolaou PBNA Pseudovirion-based neutralization assay PPE Per Protocol Efficacy PPI Per Protocol Immunogenicity qHPV vaccine Quadrivalent Human Papillomavirus vaccine RR Risk reduction SAEs Serious Adverse Experiences SCC Squamous cell carcinoma VaIN Vaginal Intraepithelial Neoplasia VE Vaccine efficacy VIN Vulvar Intraepithelial Neoplasia VLP Virus-Like Particle