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

NCT01304498 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-12-14

Study results available
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Summary

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.

Conditions

  • Human Papillomavirus

Interventions

BIOLOGICAL

V503

9-valent HPV \[Types 6, 11, 16, 18, 31, 33, 45, 52, and 58\] L1 virus-like particle vaccine

BIOLOGICAL

GARDASIL

Quadrivalent HPV \[Types 6, 11, 16, and 18\] L1 virus-like particle vaccine

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
15 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-23
Primary Completion
2011-12-20
Completion
2011-12-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01304498 on ClinicalTrials.gov