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

Not Applicable

• Registration Number: PER-037-11
• Lead Sponsor: SANOFI PASTEUR INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-04
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 320

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified