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Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

NCT00325130 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1042

Last updated 2015-03-12

Study results available
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Summary

Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) \[Types 6, 11, 16, 18\] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.

Conditions

Interventions

BIOLOGICAL

Comparator: Quadrivalent Human Papillomavirus (HPV) vaccine

Quadrivalent HPV vaccine was provided by the SPONSOR in single-dose vials containing a volume of 0.75 mL. The vaccine was administered as a 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.

BIOLOGICAL

Comparator: Menactra™ (Concomitant)

A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Day 1

BIOLOGICAL

Comparator: Adacel™ (Concomitant)

a single administration of 0.5 mL intramuscular injection administered in a limb opposite that of quadrivalent HPV injection at Day 1

BIOLOGICAL

Comparator: Menactra™ (Non-concomitant)

A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1

BIOLOGICAL

Comparator: Adacel™

A single administration of 0.5 mL intramuscular injection in a limb opposite that of quadrivalent HPV injection at Month 1

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2007-04-30
Completion
2007-04-30

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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 NCT00325130 on ClinicalTrials.gov