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Hum Vaccin Immunother. 2015;11(6):1306-12. doi: 10.1080/21645515.2015.1009819.

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.

Author information

1
a Merck & Co., Inc. ; Whitehouse Station, NJ , USA.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00943722.

KEYWORDS:

HPV; NCT# 00943722; immunogenicity; lot consistency; vaccination; vaccine

PMID:
26086587
PMCID:
PMC4514432
DOI:
10.1080/21645515.2015.1009819
[Indexed for MEDLINE]
Free PMC Article

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