Broad Spectrum HPV Vaccine Dose Ranging Study (V502-001)

Merck Sharp & Dohme LLC680 enrolled

Overview

This dose-ranging study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate that the vaccine is well-tolerated in women (2) To evaluate immune responses in women who are between 16 and 23 years of age at enrollment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

680

Conditions

HPV Cervical Cancer Premalignancy Anogenital Warts

Interventions

Comparator: GardasilBIOLOGICAL

0.5 mL intramuscular injection administered at Day 1, Month 2 and Month 6

Comparator: octavalent HPV Vaccine - dose formulation 1BIOLOGICAL

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Comparator: octavalent HPV Vaccine - dose formulation 2BIOLOGICAL

0.5 mL octavalent HPV vaccine - intramuscular injection administered at Day 1, Month 2 and Month 6

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 23 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Lifetime history of 0-4 sexual partners Exclusion Criteria: * History of abnormal PAP test or abnormal cervical biopsy result; history of external genital/vaginal warts; history of positive HPV test

Outcomes

Primary Outcomes

The octavalent HPV VLP vaccine, when administered in a 3-dose regimen, induces acceptable responses for specific HPV types at 4 weeks Post dose 3. Immune responses measured by an HPV competitive Luminex immunoassay.

Time frame: 4 weeks post dose 3 injection

Data from ClinicalTrials.gov

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