Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Aug 2, 2018

Keywords

ClinConnect Summary

This study will be divided into two cohorts, by age, with separate study designs. The first cohort will include children 9 through 11 months of age. The second cohort will comprise children 15 through 23 months of age. The purpose of this detailed evaluation of safety and immunogenicity is to assess the reactogenicity of the vaccine and the immune responses to Vi-TCV. Serum specimens will be collected from all participants on study day 0 (before vaccination) and on post-vaccination study day 28 to quantify anti-Vi and anti-tetanus toxoid antibodies. All children will have an additional 0.5 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria: Each subject receiving study vaccine (Vi-TCV or IPV) must satisfy the following inclusion criteria at study entry:
• • Male or female child 9 through11 months of age for cohort 1, or 15 months through 23 months of age for cohort 2, and in good health at the time of study vaccination.
• • A child whose parent or guardian resides primarily within the study area 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: No subject receiving study vaccine (Vi-TCV or IPV) may have any of the following exclusion criteria at study entry:
• • History of documented hypersensitivity to any component of the vaccine.
• • Prior receipt of any typhoid vaccine.
• • History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
• • Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver disease, progressive neurological disorders, poorly controlled seizures, or terminal illness.
• • Severe malnutrition as determined by a MUAC \< 12.5 cm.
• • Receipt of any other investigational intervention in the last 6 months or anticipated during the course of the study.
• • Receipt of blood products in the last 6 months.
• • Known HIV infection or exposure or other immunosuppressive conditions.
• • Receipt of systemic immunosuppressant or systemic corticosteroids.
• • Receipt of any measles-rubella-containing vaccine for children younger than 1 year of age.
• • Any condition determined by the investigator 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 a temporary contraindication to enrollment and vaccination. If this applies, the participant will be temporarily excluded for vaccination until 48 hours has passed. A re-assessment will be needed to ensure the temporary exclusion criteria no longer exist:
• • • Reported fever within 24 hours before vaccination.
• An additional temporary exclusion criteria for cohort 2 will be:
• • • Receipt of measles-rubella vaccine in the one month before enrollment, as determined by parental history or vaccination card. A child may be reassessed after 30 days has passed since receipt of MR vaccine.

Trial Officials