A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Human; Papillomavirus Infections

Treatments: Biological: Comparator: Placebo; Biological: V501

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092547

V501-018

2004_084

Details and patient eligibility

About

This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).

Full description

The original base protocol (V501-018)(NCT00092547) was extended in amendments V501-018-05 and -06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the base study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36.

The study was extended again in amendment V501-018-10(NCT00092547), titled "A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age" to allow a follow-up period to Month 126.

Enrollment: 1,781 patients

Sex: All

Ages: 9 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adolescents and preadolescents with no prior sexual history

Exclusion criteria

• Subjects with compromised immune system or have a history of severe allergic reaction

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,781 participants in 3 patient groups, including a placebo group

qHPV Vaccine in Base Study

Experimental group

Description:

Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.

Treatment:

Biological: V501

Placebo in Base Study

Placebo Comparator group

Description:

Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.

Treatment:

Biological: Comparator: Placebo

qHPV Vaccine in Extension Study

Experimental group

Description:

Represents participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.

Treatment:

Biological: V501