Completed
A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) Given Concomitantly With Menactra™ and Adacel™ in Preadolescents and Adolescents (11 to 15 Year Olds)
What is being tested
V503
+ Comparator: Menactra™ (Concomitant)
+ Comparator: Adacel™ (Concomitant)
Biological
Who is being recruted
Urogenital Diseases+10
+ Genital Diseases
+ Communicable Diseases
From 11 to 15 Years
+17 Eligibility Criteria
How is the trial designed
Prevention Study
Phase 3
Interventional
Study Start: October 2009
Summary
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 21, 2009
Actual date on which the first participant was enrolled.This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and Adacel™.
Official TitleA Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) Given Concomitantly With Menactra™ and Adacel™ in Preadolescents and Adolescents (11 to 15 Year Olds)
Principal SponsorMerck Sharp & Dohme LLC
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
1241 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 11 to 15 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsInfectionsPathologic ProcessesSexually Transmitted DiseasesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVirus DiseasesSexually Transmitted Diseases, ViralDisease AttributesPapillomavirus Infections
Criteria
4 inclusion criteria required to participate
Subject is in good health
Subject's parent/legal guardian can read, understand, and complete the vaccine report card
Subject is not sexually active and does not plan on becoming sexually active during the study
Subject has received a documented full primary immunization series against diphtheria, tetanus, and pertussis (not in the last 5 years)
13 exclusion criteria prevent from participating
Subject has a known allergy to any vaccine component of V503, Menactra™, or Adacel™
Subject has a condition that is a contraindication to vaccination with Menactra™ or Adacel™
Subject has any coagulation disorder
Female subject is pregnant
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalV503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
Group II
ExperimentalV503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers