Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Ye… (NCT03299426) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
Malawi30,000 participantsStarted 2018-02-21
Plain-language summary
This study will evaluate the efficacy of a Typhoid conjugate vaccine (Vi-TCV) in Malawi, Africa among children age 9 months through 12 years. Participants will be randomized in a 1:1 ration to receive the study vaccine or the control vaccine (meningococcal group A conjugate vaccine - MCV-A).
Who can participate
Age range9 Months – 12 Years
SexALL
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Inclusion Criteria:
* Healthy male or female child between the ages of 9 months and 12 years/364 days at the time of study vaccination.
* A child whose parent or guardian resides primarily within the Ndirande or Zingwangwa study areas at the time of study vaccinations and who intends to be present in the area for the duration of the trial.
* A child whose parent or guardian has voluntarily given informed consent.
Exclusion Criteria:
* History of documented hypersensitivity to any component of the vaccine
* Prior receipt of any typhoid vaccine in the past 3 years
* History of severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis
* Any condition determined by the investigator to be likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study.
Temporary Exclusion Criteria:
The following will be considered temporary contraindications to enrollment and vaccination. If these apply, the participant will be temporarily excluded for vaccination until 48 hours has passed. A re-assessment will be needed to ensure these temporary exclusion criteria no longer exist.
* Reported fever within 24 hours prior to vaccination
* Use of anti-pyretics within 4 hours prior to vaccination
An additional temporary exclusion criteria will be:
\- Receipt of measles vaccine in the one month prior to enrollment, as determined by parental history or vaccination card.…