Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT01073293
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
15 Years
Study:
NCT01073293
Study Brief:
Protocol Section:
NCT01073293