None listed
Conditions
Interventions
THIS STUDY WILL BE CONDUCTED IN 2 SITES IN COLOMBIA AND 1 SITE IN PERU. IF FOR ANY REASON, A SITE NOT ABLE TO REACH THE TARGET NUMBER OF TODDLERS FOR INCLUSION, THE OTHER SITE (S) MAY INCREASE THEIR R
Sponsors
SANOFI PASTEUR INC.,
Eligibility
Age
1 Years to 2 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Countries
Colombia, Peru
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed