Details

Autor(en) / Beteiligte

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

Titel

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

Ist Teil von

• Human vaccines & immunotherapeutics, 2015-06, Vol.11 (6), p.1306-1312

Ort / Verlag

United States: Taylor & Francis

Erscheinungsjahr

2015

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.