Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Genital Warts; Vulvar Cancer; Vaginal Cancer; Human Papillomavirus Infection; Cervical Cancer

Treatments: Biological: Comparator: GARDASIL; Biological: Experimental: V503

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543543

2007_538

V503-001

Details and patient eligibility

About

The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503 reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type 6/11/16/18 antibodies compared with GARDASIL.

Full description

The study included a dose-finding evaluation of a 3-dose regimen of V503 and GARDASIL, a safety/efficacy evaluation of a 3-dose regimen of the selected V503 dose formulation and GARDASIL, and an extension consisting of 2 substudies: an evaluation of immune memory in participants receiving a fourth vaccination with V503 (Cohort 1), and an opportunity for participants who received GARDASIL in the Base Study to receive a 3-dose regimen of V503 (Cohort 2).

Enrollment: 14,840 patients

Sex: Female

Ages: 16 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female between 16- to 26-years-old
• Has never had Pap testing or has only had normal Pap (Papanicolaou) test results
• For the immune memory substudy in the extension (Cohort 1): was randomized to V503 in the base study and was in the per-protocol immunogenicity population for ≥1 HPV type
• For the 3-dose V503 vaccination substudy in the extension (Cohort 2): was randomized to GARDASIL in the base study and received ≥1 dose of GARDASIL

Exclusion criteria

• History of an abnormal cervical biopsy result
• History of a positive test for HPV
• History of external genital/vaginal warts
• Currently a user of any illegal drugs or an alcohol abuser
• History of severe allergic reaction that required medical attention
• Are pregnant
• Received marketed HPV vaccine or participated in an HPV trial
• Currently enrolled in a clinical trial
• Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14,840 participants in 4 patient groups

Low-dose V503

Experimental group

Description:

V503 (9-Valent Human Papillomavirus \[HPV\] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.

Treatment:

Biological: Experimental: V503

Mid-dose V503

Experimental group

Description:

V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.

Treatment:

Biological: Experimental: V503

High-dose V503

Experimental group

Description:

V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.

Treatment:

Biological: Experimental: V503

Gardasil

Active Comparator group

Description:

Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.

Treatment:

Biological: Experimental: V503

Biological: Comparator: GARDASIL