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A phase III, double-blind, randomized study to assess the consistency of the immunogenicity of three consecutive production lots of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine administered...

Update Il y a 4 ans
Reference: EUCTR2005-001667-58

A phase III, double-blind, randomized study to assess the consistency of the immunogenicity of three consecutive production lots of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine administered intramuscularly according to a 0, 1, 6-month schedule in healthy female subjects aged 18 – 25 years and to demonstrate non-inferiority of the candidate HPV vaccine manufactured at 600L scale compared with a lower (80L) manufacturing scale

Woman Man

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Extract

First primary objective: •To demonstrate lot-to-lot consistency in terms of immunogenicity between three consecutive industrial production lots (600L scale) of the HPV-16/18 VLP/AS04 vaccine one month after the third dose (Month 7). Second primary objective: •To demonstrate that the HPV vaccine produced at 600L manufacturing scale is non-inferior in terms of immunogenicity to the HPV vaccine produced at 80L scale one month after the third dose (Month 7).

Inclusion criteria

  • For active immunization of women from the age of 10 onwards to prevent persistent HPV-16 and HPV-18 infection and HPV-16 and HPV-18 associated cervical neoplasia

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