Phase III, randomized controlled trial in girls 9-15 years old to evaluate lot consistency of a novel nine-valent human papillomavirus L1 virus-like particle vaccine.

Submitted by Ana Maria Fiscina Sampaio ([email protected]) on 2016-05-19T16:33:36Z No. of bitstreams: 1 Luxembourg A Phase III randomized....pdf: 260849 bytes, checksum: 9a8fe8cac615dc614bc4e27e52a1aab6 (MD5)Approved for entry into archive by Ana Maria Fiscina Sampaio ([email protected]) on 2016-05-19T16:52:18Z (GMT) No. of bitstreams: 1 Luxembourg A Phase III randomized....pdf: 260849 bytes, checksum: 9a8fe8cac615dc614bc4e27e52a1aab6 (MD5)Made available in DSpace on 2016-05-19T16:52:18Z (GMT). No. of bitstreams: 1 Luxembourg A Phase III randomized....pdf: 260849 bytes, checksum: 9a8fe8cac615dc614bc4e27e52a1aab6 (MD5) Previous issue date: 2015Merck & Co. Inc. Whitehouse Station. NJ, USAHospital Santo Antônio. Obras Sociais Irmã Dulce. Salvador, BA, BRasilm/ Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, BrasilPhramongkutklao Hospital. Deptartment of Pediatrics. Bangkok, ThailandEwha Womans University School of Medicine. Department of Pediatrics. Seoul, KoreaMerck & Co. Inc. Whitehouse Station. NJ, USAMerck & Co. Inc. Whitehouse Station. NJ, USAMerck & Co. Inc. Whitehouse Station. NJ, USAMerck & Co. Inc. Whitehouse Station. NJ, USAMerck & Co. Inc. Whitehouse Station. NJ, USAA 9-valent human papillomavirus (6/11/16/18/31/33/45/52/58) VLP (9vHPV) vaccine has recently been proven highly efficacious in preventing disease associated with vaccine HPV types in a pivotal Phase III study. The demonstration of lot-to-lot consistency to confirm the reliability of the manufacturing process is a regulatory requirement for vaccine licensure in the United States. A randomized trial was conducted to demonstrate that three lots of 9vHPV vaccine elicit equivalent antibody response for all 9 vaccine types. The study required thorough planning because it required success on 27 separate statistical comparisons. An innovative statistical approach was used taking into account between-lot variance for more conservative power calculations. The study demonstrated equivalence of three lots of 9vHPV vaccine for all 9 vaccine type