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

Alain Luxembourg, Edson D. Moreira, Rudiwilai Samakoses, Kyung Hyo Kim, Xiao Sun, Roger Maansson, Erin Moeller, Susan Christiano, Joshua Chen

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

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.

Original languageEnglish
Pages (from-to)1306-1312
Number of pages7
JournalHuman Vaccines and Immunotherapeutics
Volume11
Issue number6
DOIs
StatePublished - 1 Jan 2015

Keywords

  • HPV
  • Immunogenicity
  • Lot consistency
  • NCT# 00943722
  • Vaccination
  • Vaccine

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this