Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Human Papillomavirus

Treatments: Biological: GARDASIL; Biological: V503

Study type: Interventional

Funder types: Industry

Identifiers

NCT01304498

V503-009

2010-023393-39 (EudraCT Number)

GDS01C (Other Identifier)

Details and patient eligibility

About

Primary objective:

• To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.

Secondary objectives:

• To evaluate the tolerability of V503 in 9-15 year-old girls.
• To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.

Enrollment: 600 patients

Sex: Female

Ages: 9 to 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female from 9 to 15 years old.
• Good physical health.

Exclusion criteria

• Known allergy to any vaccine component.
• History of severe allergic reaction.
• Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
• Pregnant subject.
• Immunocompromised or immunodeficient subject.
• Splenectomy.
• Receipt of medication / vaccine that may interfere with study assessment.
• Fever
• History of a positive test for HPV, prior receipt of HPV vaccine or prior participation to HPV trial.
• Any condition that might interfere with study assessment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups

V503

Experimental group

Description:

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6

Treatment:

Biological: V503

GARDASIL

Active Comparator group

Description:

Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine, 0.5-mL intramuscular injection in 3 dose regimen at Day 1, Month 2, and Month 6

Treatment:

Biological: GARDASIL