A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00988884
First received: October 1, 2009
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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™.


Condition Intervention Phase
Human Papillomavirus Infection
Biological: V503
Biological: Comparator: Menactra™ (Concomitant)
Biological: Comparator: Adacel™ (concomitant)
Biological: Comparator: Menactra™ (Non-Concomitant)
Biological: Comparator: Adacel™ (Non-concomitant)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric Mean Titers (GMTs) of the Antibody Response to Each of the HPV Types Contained in V503 [ Time Frame: 4 Weeks Postdose 3 of V503 ] [ Designated as safety issue: No ]
  • Percentage of Subjects with 4 Fold or Greater Rise in Titers for Neisseria meningitidis serogroup A, C, Y, and W-135 [ Time Frame: One Month Postvaccination ] [ Designated as safety issue: No ]
  • Percentage of Subjects Who Achieve Acceptable Levels of Anti-Diphtheria and Anti-Tetanus Titers [ Time Frame: One Month Postvaccination ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of the Pertussis (PT, FHA, FIM, and PRN) Antibody Responses [ Time Frame: One Month Postvaccination ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Injection Site Adverse Experiences occurring Day 1 through Day 5 Following the First Vaccination [ Time Frame: Day 1 through Day 5 Following the First Vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of Patients With Temperature >= 100.0F from Day 1 through Day 5 Following the Day 1 and Month 1 Vaccinations [ Time Frame: Day 1 through Day 5 Following the Day 1 and Month 1 Vaccinations ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Subjects who Seroconvert for Each of the HPV Types Contained in V503 [ Time Frame: 4 Weeks Postdose 3 of V503 ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of the Neisseria meningitidis Serogroup A, C, Y, and W-135 Antibody Responses [ Time Frame: One Month Postvaccination ] [ Designated as safety issue: No ]

Enrollment: 1241
Study Start Date: October 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Concomitant group
Biological: V503
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: Comparator: Menactra™ (Concomitant)
Menactra™ given as a single 0.5 mL intramuscular injection on Day 1.
Biological: Comparator: Adacel™ (concomitant)
Adacel™ given as a single 0.5 mL intramuscular injection on Day 1.
Experimental: 2
Non-Concomitant Group
Biological: V503
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: Comparator: Menactra™ (Non-Concomitant)
Menactra™ given as a single 0.5 mL intramuscular injection at Month 1.
Biological: Comparator: Adacel™ (Non-concomitant)
Adacel™ given as a single 0.5 mL intramuscular injection at Month 1.

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • Subject is immunocompromised or immunodeficient
  • Subject has had a splenectomy
  • Subject has received immunosuppressive therapies in the prior year
  • Subject has received any immune globulin product or blood-derived product in the last 3 months
  • Subject has received inactivated vaccines within 14 days or live vaccines within 21 days of the first study vaccination
  • Subject has received a marketed HPV vaccine or has participation in an HPV vaccine trial
  • Subject has received a meningococcal vaccine
  • Subject has a fever >= 100F within 24 hours of vaccination
  • Subject has a history of HPV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988884

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00988884     History of Changes
Other Study ID Numbers: V503-005, V503-005
Study First Received: October 1, 2009
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on August 21, 2014