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)
Inclusion 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