Article
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.
Registro en:
LUXEMBOURG, A. et al. 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. Human Vaccines & Immunotherapeutics, v. 11, n. 6, p. 1306-1312, 2015.
2164-5515
/dx.doi.org/10.1080/21645515.2015.1009819
Autor
Luxembourg, Alain
Moreira Junior, Edson Duarte
Samakoses, Rudiwilai
Kim, Kyung-Hyo
Sun, Xiao
Maansson, Roger
Moeller, Erin
Christiano, Susan
Chen, Joshua
Resumen
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