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A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)

Genital Warts Clinical Trial

Official title:
A Phase III, Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™

Clinical Trial Summary

This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the Base Study. Participants who receive placebo in the Base Study will be eligible to receive vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01047345
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 3
Start date February 24, 2010
Completion date November 28, 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Completed NCT03158220 - Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) Phase 3
Completed NCT01651949 - Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003) Phase 3
Completed NCT00551187 - A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED) Phase 2
Completed NCT00520598 - Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001) Phase 2
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Active, not recruiting NCT05314023 - Immunogenicity and Safety of V503 in Chinese Males 9 Through 19 Years Old (V503-053) Phase 3
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Completed NCT00189293 - Study of Imiquimod Cream Prior to Ablative Therapy in External Ano-Genital Warts Phase 4
Active, not recruiting NCT00092534 - Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015) Phase 3
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Completed NCT00501137 - A Controlled Trial to Assess the Immunogenicity of a Proposed Paediatric Dosing Schedule of Human Papillomavirus Vaccine Phase 3
Active, not recruiting NCT02750202 - Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts Phase 3