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A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)

NCT01073293 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1054

Last updated 2018-11-27

Study results available
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Summary

This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503.

Conditions

  • Papillomavirus Infections

Interventions

BIOLOGICAL

V503 Vaccine

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

BIOLOGICAL

REPEVAX™ (Concomitant)

REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1

BIOLOGICAL

REPEVAX™ (Non-concomitant)

REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-22
Primary Completion
2011-06-16
Completion
2011-06-16

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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 NCT01073293 on ClinicalTrials.gov