A PHASE III CLINICAL TRIAL TO STUDY THE TOLERABILITY AND IMMUNOGENICITY OF V503, A MULTIVALENT HUMAN PAPILOMAVIRUS (HPV) L1 VIRUS-LIKE PARTICICLE (VLP) VACCINE, IN 16- TO 26-YEAR-OLD MEN AND 16- TO 26-YEAR-OLD WOMEN.
- Registration Number
- PER-105-12
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 200
1. SUBJECT IS MALE OR FEMALE, BETWEEN THE AGES OF 16 YEARS AND 0 DAYS AND 26 YEARS AND 364 DAYS ON THE DAY OF ENROLLMENT.
2. SUBJECT IS JUDGED TO BE IN GOOD PHYSICAL HEALTH ON THE BASIS OF MEDICAL HISTORY, PHYSICAL EXAMINATION, AND LABORATORY RESULTS.
3. SUBJECT (OR, FOR MINOR SUBJECTS, PARENT/LEGAL GUARDIAN AND SUBJECT) FULLY UNDERSTANDS STUDY PROCEDURES, ALTERNATIVE TREATMENTS AVAILABLE, THE RISKS INVOLVED WITH THE STUDY, AND VOLUNTARILY AGREES TO PARTICIPATE BY GIVING WRITTEN INFORMED CONSENT. THE SUBJECT MAY ALSO PROVIDE CONSENT/ASSENT FOR FUTURE BIOMEDICAL RESEARCH. HOWEVER, THE SUBJECT MAY PARTICIPATE IN THE MAIN TRIAL WITHOUT PARTICIPATING IN FUTURE BIOMEDICAL RESEARCH.
4. SUBJECT AGREES TO PROVIDE STUDY PERSONNEL WITH A PRIMARY TELEPHONE NUMBER AS WELL AS AN ALTERNATE TELEPHONE NUMBER FOR FOLLOW-UP PURPOSES.
5. SUBJECT IS ABLE TO READ, UNDERSTAND, AND COMPLETE THE VACCINATION REPORT CARD.
6. A) (HM AND FEMALE SUBJECTS ONLY) SUBJECT HAS A LIFETIME HISTORY OF 0 TO 4 MALE AND/OR FEMALE SEXUAL PARTNERS AT THE TIME OF ENROLLMENT.
B) (MSM SUBJECTS ONLY) SUBJECT HAS A LIFETIME HISTORY OF UP TO 5 MALE AND/OR FEMALE SEXUAL PARTNERS AT THE TIME OF ENROLLMENT.
MALE OR FEMALE PARTNER IS DEFINED AS SOMEONE WITH WHOM THE SUBJECT HAS
1. SUBJECT HAS A KNOWN ALLERGY TO ANY VACCINE COMPONENT, INCLUDING ALUMINUM, YEAST, OR BENZONASETM (NUCLEASE, NYCOMED [USED TO REMOVE RESIDUAL NUCLEIC ACIDS FROM THIS AND OTHER VACCINES]). FOR THE PURPOSE OF THIS EXCLUSION CRITERION, AN ALLERGY TO VACCINE COMPONENTS IS DEFINED AS AN ALLERGIC REACTION THAT MET THE CRITERIA FOR A SERIOUS ADVERSE EXPERIENCE.
2. SUBJECT HAS A HISTORY OF SEVERE ALLERGIC REACTION (E.G., SWELLING OF THE MOUTH AND THROAT, DIFFICULTY BREATHING, HYPOTENSION, OR SHOCK) THAT REQUIRED MEDICAL INTERVENTION.
3. SUBJECT HAS THROMBOCYTOPENIA OR ANY COAGULATION DISORDER THAT WOULD CONTRAINDICATE INTRAMUSCULAR INJECTIONS.
4. SUBJECT IS CONCURRENTLY ENROLLED IN ANOTHER CLINICAL STUDY OF INVESTIGATIONAL AGENTS.
5. (FEMALE SUBJECTS ONLY) - SUBJECT IS PREGNANT (AS DETERMINED BY A SERUM PREGNANCY TEST OR URINE PREGNANCY TEST THAT IS SENSITIVE TO 25 MIU/ML (B-HCG).
6. (FEMALE SUBJECTS ONLY) SUBJECT IS EXPECTING TO DONATE EGGS DURING DAY 1 THROUGH MONTH 7 OF THE STUDY.
7. SUBJECT IS CURRENTLY IMMUNOCOMPROMISED OR HAS BEEN DIAGNOSED AS HAVING A CONGENITAL OR ACQUIRED IMMUNODEFICIENCY, HIV INFECTION, LYMPHOMA, LEUKEMIA, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE), RHEUMATOID ARTHRITIS, JUVENILE RHEUMATOID ARTHRITIS (JRA), INFLAMMATORY BOWEL DISEASE, OR OTHER AUTOIMMUNE CONDITION.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method