a study of v503 vaccine given concomitantly with repevax™ in 11 to 15 year olds (v503-007)

Conditions: Papillomavirus Infections

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