A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Intervention: V503 Vaccine; REPEVAX™ (Concomitant); REPEVAX™ (Non-concomitant)
Intervention description: V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6; REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1; REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1054.0
Sex: All
Minimum age: 11 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility 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