Efficacy of Quadrivalent HPV Vaccine to Prevent Relapses of Genital Warts After Initial Therapeutic Response

Exclusion Criteria

• •Patients with diagnosis of internal ano-genital warts (intra rectal, intra vaginal, intra urethral) at the selection visit
• •Patients with positive HIV, Hepatitis C virus (HCV) or Hepatitis B virus (HBV) (Ag HBS) tests;
• •Patients whose regular partner(s) have active uncontrolled clinical EGW;
• •Patients who received the HPV Vaccine at any time before enrolment to the study;
• •Any serious chronic or progressive disease according to the judgement of the investigator;
• •Patients with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic immunosuppressant medication (more than 14 days) (i.e. prednisone, or equivalent ≥10 mg/day) within :
• •* the 28 days preceding the first vaccination at the inclusion visit V1 in case of corticosteroids administration
• •* the 3 months preceding the first vaccination at the inclusion visit V1 in case of administration of cyclophosphamide, anti-Tumor Necrosis Factor (TNF) alpha , intravenous immunoglobulins, abatacept, corticosteroids as a bolus injection
• •* the 6 months preceding the first vaccination at the inclusion visit V1 in case of Cluster of Differentiation antigen 20 (anti-CD20) administration. Topical or inhaled uses of steroid including intranasal are allowed;
• •Patients with history of known allergies/hypersensitivity to any component of study vaccine;
• •Patients who have any malignancy or lymphoproliferative disorder;
• •Patients with thrombocytopenia or coagulation disorder/treatment contra-indicating intramuscular injection;
• •Women who are pregnant or are breast-feeding, or are of childbearing age who do not use or do not plan to use acceptable birth control measures, during the first 6 months of the study ;
• •Male who do not use or do not plan to use condoms during the first 6 months of the study;
• •Patients under a measure of legal protection or unable to consent;
• •Patients participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.