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Phase III lot-consistency study of GSK HPV-16/18 AS04-adjuvanted vaccine in healthy women aged 18-25 years

2005-001667-58Phase 3Completed

Sponsor
GSK
Start
Sep 2005
Modality
Vaccines & Immunotherapeutics
Countries
1
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Overview

Phase 3, randomised, double-blind trial of recombinant human papillomavirus bivalent (types 16 and 18) vaccine in human papillomavirus infection and cervical dysplasia (CIN) (4 arms), sponsored by GSK. Primary endpoints: Anti-HPV-16/18 seroconversion and seropositivity rates at Month 7, Immunogenicity consistency across three industrial-scale lots and 1 more. Started Sep 2005; status: completed.

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Drugs

recombinant human papillomavirus bivalent (types 16 and 18) vaccine
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Conditions

human papillomavirus infectioncervical dysplasia (CIN)

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