title: 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.
abstract: A 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 types.
authors.affiliation: a Merck & Co., Inc. ; Whitehouse Station, NJ , USA.
authors.forename: Alain
authors.initials: A
authors.lastname: Luxembourg
authors.forename: Edson D
authors.initials: ED
authors.lastname: Moreira
authors.forename: Rudiwilai
authors.initials: R
authors.lastname: Samakoses
authors.forename: Kyung-Hyo
authors.initials: KH
authors.lastname: Kim
authors.forename: Xiao
authors.initials: X
authors.lastname: Sun
authors.forename: Roger
authors.initials: R
authors.lastname: Maansson
authors.forename: Erin
authors.initials: E
authors.lastname: Moeller
authors.forename: Susan
authors.initials: S
authors.lastname: Christiano
authors.forename: Joshua
authors.initials: J
authors.lastname: Chen
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D056808:Biostatistics / Q000379:methods; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D016896:Treatment Outcome; D014481:United States; D058425:Vaccines, Virus-Like Particle / Q000008:administration & dosage* / Q000276:immunology*; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines; D058425:Vaccines, Virus-Like Particle
keywords: HPV; NCT# 00943722; immunogenicity; lot consistency; vaccination; vaccine