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Clinical Trials/PER-037-11
PER-037-11
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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 sites320 target enrollmentAugust 4, 2011
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
SANOFI PASTEUR INC.,
Enrollment
320
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 4, 2011
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
SANOFI PASTEUR INC.,

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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