V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: HPV Infections

Treatments: Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501); Biological: Comparator: Placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411749

V501-028

2006_052

Details and patient eligibility

About

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females

Enrollment: 107 patients

Sex: Female

Ages: 9 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Virginal Female Subject Aged 9 To 17 Years

Exclusion criteria

• Male Subject

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups, including a placebo group

V501

Experimental group

Description:

V501 vaccination Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Vaccine Injection cervix cancer exgenlesion Vaccination at Day 1, Month 2, and Month 6. Total 3 vaccinations. 0.5 mL intramuscular dose of V501 (HPV L1 Virus-Like Particle \[VLP\] Type 6, Type 11, Type 16, Type 18) or placebo at Day 1, Month 2 and Month 6.

Treatment:

Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)

Placebo

Placebo Comparator group

Description:

Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen

Treatment:

Biological: Comparator: Placebo (unspecified)