A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007 AM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01073293
First received: February 19, 2010
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503.


Condition Intervention Phase
Papillomavirus Infections
Biological: V503 Vaccine
Biological: REPEVAX™ (Concomitant)
Biological: REPEVAX™ (Non-concomitant)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy 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 REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)

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 Human Papillomavirus (HPV) Types Contained in V503 [ Time Frame: 4 weeks post-dose 3 of V503 ] [ Designated as safety issue: No ]
  • Number of participants reporting injection site adverse experiences [ Time Frame: Day 1 to Day 5 following Day 1 V503 administration ] [ Designated as safety issue: Yes ]
  • Number of participants reporting injection site adverse experiences [ Time Frame: Day 1 to Day 5 following Day 1/Month 1 REPEVAX™ administration ] [ Designated as safety issue: Yes ]
  • Number of participants reporting elevated temperatures [ Time Frame: Day 1 to Day 5 post Day 1/Month 1 vaccinations/visits ] [ Designated as safety issue: Yes ]
  • Number of participants reporting systemic adverse experiences [ Time Frame: Day 1 to Day 15 following Day 1/Month 1 vaccinations/visits ] [ Designated as safety issue: Yes ]
  • The percentage of participants who achieve acceptable levels of anti-diphtheria and anti-tetanus titers [ Time Frame: One month post-vaccination ] [ Designated as safety issue: No ]
  • The anti-pertussis (anti-pertussis toxin [anti-PT], anti-filamentous hemagglutinin [anti-FHA] anti-fimbrial agglutinogens [anti-FIM], and anti-pertactin [anti-PRN]) geometric mean titers (GMTs) [ Time Frame: One month post-vaccination ] [ Designated as safety issue: No ]
  • The percentages of participants with acceptable levels of titers for polio antigens [ Time Frame: One month after REPEVAX™ vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of participants who seroconvert for each of the human papillomavirus (HPV) types contained in V503 [ Time Frame: 4 weeks post-dose 3 of V503 ] [ Designated as safety issue: No ]

Enrollment: 1054
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Concomitant Biological: V503 Vaccine
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: REPEVAX™ (Concomitant)
REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1
Experimental: Non-concomitant Biological: V503 Vaccine
V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
Biological: REPEVAX™ (Non-concomitant)
REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1

Detailed Description:

This amendment is to update the definitions of adverse event relationship to study vaccine.

  Eligibility

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

Inclusion criteria:

  • Participant is in good health
  • Participant's parent/legal guardian can read, understand, and complete the vaccination report card
  • Participant is not sexually active and does not plan on becoming sexually active during the study
  • Participant has received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5-year interval from a prior vaccination containing any one of these vaccine antigens.

Exclusion Criteria:

  • Participant has a known allergy to any vaccine component of V503 or REPEVAX™
  • Participant has had a severe reaction affecting the brain (e.g., evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine
  • Participant has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus or a component pertussis combination (acellular and whole cell) vaccine
  • Participant ever had Guillain-Barré syndrome or brachial neuritis following a previous dose of a tetanus-containing vaccine
  • Participant has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™
  • Participant has a history of severe allergic reaction that required medical intervention
  • Participant has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections
  • Participant is concurrently enrolled in clinical studies of investigational agents
  • Female participant is pregnant
  • Participant has donated blood within 1 week prior to first study vaccination, or intends to donate during the study
  • Participant is immunocompromised, immunodeficient, or has an autoimmune condition
  • Participant has had a splenectomy
  • Participant has received immunosuppressive therapies in the prior year
  • Participant has received immune globulin product or blood-derived product in the last 3 months
  • Participant has received inactivated vaccine(s) within 14 days or live vaccine(s) within 21 days of first study vaccination
  • Participant has received a marketed HPV vaccine or has participated in an HPV vaccine trial
  • Participant has received a tetanus, diphtheria, pertussis, or poliovirus (inactivated and/or oral poliovirus) vaccination within the last 5 years
  • Participant has a fever ≥100°F within 24 hours of vaccination
  • Participant has any history or current condition, therapy, lab abnormality, or other circumstance such that it is not in the best interest of the participant to participate
  • Participant and parent/legal guardian are unable to give assent/consent
  • Participant is unlikely to adhere to the study procedures or is planning to relocate during the study
  • Participant has recent history of illicit drug or alcohol abuse
  • Participant has a history of HPV
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01073293     History of Changes
Other Study ID Numbers: V503-007, 2010_512
Study First Received: February 19, 2010
Last Updated: September 6, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

ClinicalTrials.gov processed this record on April 16, 2014