IMMUNOGENICITY AND SAFETY OF YELLOW FEVER VACCINE (STAMARIL®) ADMINISTERED CONCOMITANTLY WITH TETRAVALENT DENGUE VACCINE IN HEALTHY TODDLERS AT 12-13 MONTHS OF AGE IN COLOMBIA AND PER

SANOFI PASTEUR INC.,0 个研究点目标入组 320 人开始时间: 2011年8月4日最近更新: 2023年9月4日

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•1) AGE 12 TO 13 MONTHS ON THE DAY OF INCLUSION
•2) BORN AT FULL TERM OF PREGNANCY (≥ 37 WEEKS) AND WITH A BIRTH WEIGHT ≥ 2.5 KG AS REPORTED BY THE PARENT/LEGALLY ACCEPTABLE REPRESENTATIVE.
•3) SUBJECT IN GOOD HEALTH, BASED ON MEDICAL HISTORY AND PHYSICAL EXAMINATION
•4) SUBJECT HAS COMPLETED HIS/HER VACCINATION SCHEDULE ACCORDING OF THE OFFICIAL IMMUNIZATION CALENDAR OF COLOMBIA AND/OR PERU, RESPECTIVELY.
•5) INFORMED CONSENT FORM HAS BEEN SIGNED AND DATED BY THE PARENT (S) OR OTHER LEGALLY ACCEPTABLE REPRESENTATIVE (AND BY 2 INDEPENDENT WITNESSES IF REQUIRED BY LOCAL REGULATIONS).
•6) SUBJECT AND PARENT/LEGALLY ACCEPTABLE REPRESENTATIVE/TUTOR ABLE TO ATTEND ALL SCHEDULED VISITS AND TO COMPLY WITH ALL TRIAL PROCEDURES

•1) PARTICIPATION IN ANOTHER CLINICAL TRIAL INVESTIGATING A VACCINE, DRUG, MEDICAL DEVICE, OR MEDICAL PROCEDURE IN THE 4 WEEKS PRECEDING THE FIRST TRIAL VACCINATION.
•2) PLANNED PARTICIPATION IN ANOTHER CLINICAL TRIAL DURING THE PRESENT TRIAL PERIOD.
•3) PLANNED RECEIPT OF ANY VACCINE IN THE 4 WEEKS FOLLOWING FIRST TRIAL VACCINATION.
•4) PREVIOUS VACCINATION AGAINST YF, HEPATITIS A, OR MEASLES, MUMPS AND RUBELLA.
•5) RECEIPT OF BLOOD OR BLOOD-DERIVED PRODUCTS IN THE PAST 3 MONTHS WHICH MIGTH INTERFERE WITH ASSESSMENT OF THE IMMUNE RESPONSE.
•6) KNOWN OR SUSPECTED CONGENITAL OR ACQUIRED IMMUNODEFICIENCY; OR RECEIPT OF IMMUNOSUPPRESSIVE THERAPY SUCH AS ANTI-CANCER CHEMOTHERAPY OR RADIATION THERAPY WITHIN THE PRECEDING 6 WEEKS OR LONG-TERM SYSTEMIC CORTICOSTEROID THERAPY (PREDNISONE OR EQUIVALENT FOR MORE THAN 2 CONSECUTIVE WEEKS WITHIN THE PAST 3 MONTHS).
•7) PERSONAL KNOWN SEROPOSITIVITY FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) AS REPORTED BY THE PARENT/LEGALLY ACCEPTABLE REPRESENTATIVE.
•8) HISTORY OF PREVIOUS MATERNAL VACCINATION AGAINST YF AS REPORTED BY THE PARENT/LEGALLY ACCEPTABLE REPRESENTATIVE.
•9) PERSONAL HISTORY OF YF OR DENGUE INFECTION/DISEASE AS REPORTED BY THE PARENT/LEGALLY ACCEPTABLE REPRESENTATIVE.

发起方

SANOFI PASTEUR INC.,