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Phase III trial of 2-dose 9-valent HPV vaccine in adolescents compared with 3-dose regimen in young women

2013-001314-15Phase 3Completed

Sponsor
Merck & Co.
Start
Nov 2013
Modality
Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Protein Vaccines → Recombinant Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Proteins and Enzymes
Countries
1
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Overview

Phase 3 trial of recombinant human papillomavirus 9-valent vaccine in human papillomavirus infection (4 arms), sponsored by Merck & Co. Primary endpoints: Non-inferiority of GMTs in girls aged 9 to 14 years receiving 2 doses at Day 1 and Month 6 versus young women aged 16 to 26 years receiving 3 doses, Non-inferiority of GMTs in boys aged 9 to 14 years receiving 2 doses at Day 1 and Month 6 versus young women aged 16 to 26 years receiving 3 doses and 1 more. Started Nov 2013; status: completed.

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Drugs

recombinant human papillomavirus 9-valent vaccine
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Conditions

human papillomavirus infection

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