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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
ClinicalTrials.gov Identifier:
NCT00988884
First received: October 1, 2009
Last updated: January 30, 2012
Last verified: January 2012
History of Changes

October 1, 2009
January 30, 2012
October 2009
February 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00988884 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)(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)

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™.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Human Papillomavirus Infection
  • 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.
  • 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.
  • Experimental: 1
    Concomitant group
    Interventions:
    • Biological: V503
    • Biological: Comparator: Menactra™ (Concomitant)
    • Biological: Comparator: Adacel™ (concomitant)
  • Experimental: 2
    Non-Concomitant Group
    Interventions:
    • Biological: V503
    • Biological: Comparator: Menactra™ (Non-Concomitant)
    • Biological: Comparator: Adacel™ (Non-concomitant)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1245
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
11 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00988884
2009_670, V503-005
Yes
Merck
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP