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
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:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on April 22, 2014