None listed
Conditions
Interventions
APPROXIMATELY 1100 HEALTHY YOUNG HM (16 TO 26 YEARS OF AGE) AND APPROXIMATELY 1100 HEALTHY YOUNG WOMEN (16 TO 26 YEARS OF AGE) WILL BE ENROLLED. IN ADDITION, APPROXIMATELY 300 MSM SUBJECTS (16 TO 26 Y
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
16 Years to 26 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Countries
Canada, Colombia, Denmark, Germany, Israel, Malasya, Mexico, Norway, Peru, Poland, Spain, Sweden, Thailand, Turkey, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed