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.
Hum Vaccin Immunother
; 11(6): 1306-12, 2015.
Article
en En
| MEDLINE
| ID: mdl-26086587
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.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Vacunas contra Papillomavirus
/
Vacunas de Partículas Similares a Virus
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Anticuerpos Antivirales
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Adult
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Child
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Female
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Humans
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Male
País como asunto:
America do norte
Idioma:
En
Año:
2015
Tipo del documento:
Article