Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Genital Warts

Vulvar Cancer

Vaginal Cancer

Human Papillomavirus Infection

Cervical Cancer

Treatments

Biological: V503

Study type

Interventional

Funder types

Industry

Identifiers

NCT03158220

V503-004

Details and patient eligibility

About

This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.

Enrollment

1,212 patients

Sex

Female

Ages

16 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

good physical health

Exclusion criteria

history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results
history of HPV-related condition
history of known prior vaccination with an HPV vaccine
pregnant
user of recreational or illicit drugs
history of severe allergic reaction, including known allergy to any vaccine component
immunocompromised
history of certain medications or is currently taking or has taken certain medications (details will be discussed at the time of consent)
has thrombocytopenia or other coagulation disorder
concurrently enrolled in a clinical study of investigational agent