Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03614533
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2018-07-11
Brief Title:
Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou Burkina Faso
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Controlled Trial of the Safety and Immunogenicity of Typhoid Conjugate Vaccine Vi-TCV Among Children Younger Than 2 Years in Ouagadougou Burkina Faso
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Typhoid fever is an illness that may cause mild effects in children such as fever and feeling tired or it may cause serious effects-- even death A new typhoid vaccine has recently been recommended by the World Health Organization WHO to prevent typhoid in children But this new typhoid vaccine has not been tested with all of the vaccines given to children in Burkina Faso The investigators want to look at this new vaccine and study how safe it is in children in Burkina Faso and how their immune systems respond to the vaccine when given with other vaccines such as yellow fever and meningitis A vaccines
The investigators plan to vaccinate 100 children between the ages of 9-11 months and 150 children between the ages of 15 months and 2 years in Ouagadougou Burkina Faso with either the typhoid vaccine or a vaccine against another illness called polio
Children will have follow-up visits on days 3 7 28 and 180 One teaspoon of blood will be collected on days 0 and 28
The investigators plan to vaccinate 100 children between the ages of 9-11 months and 150 children between the ages of 15 months and 2 years in Ouagadougou Burkina Faso with either the typhoid vaccine or a vaccine against another illness called polio
Children will have follow-up visits on days 3 7 28 and 180 One teaspoon of blood will be collected on days 0 and 28
Detailed Description:
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 05 mL of blood collected on study day 0 before study vaccination to test for the presence of malaria parasitemia at baseline
Children 9 through 11 months of age in the Ouagadougou study area will be eligible for the first age cohort which will be a double-blind individually randomized controlled trial Up to 100 children in this cohort will be randomized in a 11 ratio to receive Vi-TCV Group 1 or IPV Group 2 Participants will be unaware of which study vaccine Vi-TCV or IPV is received Vi-TCV or IPV will be administered with measles-rubella vaccine MR and YFV as per Burkina Faso Expanded Programme on Immunization EPI schedule These 9 through 11-month-old children will have immunogenicity to Vi-TCV YFV and tetanus toxoid assessed on study days 0 and 28
Children 15 through 23 months of age in the Ouagadougou study area will be eligible for the second cohort a randomized study of the safety and immunogenicity of Vi-TCV when co-administered with routine Expanded Programme on Immunisation EPI vaccines MAV and MR or given alone and MAV immunogenicity when co-adminstered or given alone Participants in this cohort up to 150 will be randomized 111 to one of three treatment groups as follows The first group of participants Group A will receive Vi-TCV and IPV at study day 0 with a subsequent dose of MAV at study day 28 the second group of participants Group B will receive MAV and Vi-TCV at study day 0 the third group Group C will receive MAV and IPV at study day 0 All children will receive MR at study day 0 Cohort 1 will be unblinded on day 28 for safety and follow-up and to ensure MAV receipt in Group A These 15 through 23-month-old children will have antibody to meningococcal A vaccine anti-Vi antibody and tetanus toxoid antibody assessed on study days 0 and 28
Participants in both cohorts will have home or clinic visits on days 3 and 7 following vaccination for solicitation of local and systemic adverse events Non-serious adverse events will be assessed up until the study day 28 visit Serious adverse events will be captured throughout study follow-up and actively during the study day 180 visit
Children 9 through 11 months of age in the Ouagadougou study area will be eligible for the first age cohort which will be a double-blind individually randomized controlled trial Up to 100 children in this cohort will be randomized in a 11 ratio to receive Vi-TCV Group 1 or IPV Group 2 Participants will be unaware of which study vaccine Vi-TCV or IPV is received Vi-TCV or IPV will be administered with measles-rubella vaccine MR and YFV as per Burkina Faso Expanded Programme on Immunization EPI schedule These 9 through 11-month-old children will have immunogenicity to Vi-TCV YFV and tetanus toxoid assessed on study days 0 and 28
Children 15 through 23 months of age in the Ouagadougou study area will be eligible for the second cohort a randomized study of the safety and immunogenicity of Vi-TCV when co-administered with routine Expanded Programme on Immunisation EPI vaccines MAV and MR or given alone and MAV immunogenicity when co-adminstered or given alone Participants in this cohort up to 150 will be randomized 111 to one of three treatment groups as follows The first group of participants Group A will receive Vi-TCV and IPV at study day 0 with a subsequent dose of MAV at study day 28 the second group of participants Group B will receive MAV and Vi-TCV at study day 0 the third group Group C will receive MAV and IPV at study day 0 All children will receive MR at study day 0 Cohort 1 will be unblinded on day 28 for safety and follow-up and to ensure MAV receipt in Group A These 15 through 23-month-old children will have antibody to meningococcal A vaccine anti-Vi antibody and tetanus toxoid antibody assessed on study days 0 and 28
Participants in both cohorts will have home or clinic visits on days 3 and 7 following vaccination for solicitation of local and systemic adverse events Non-serious adverse events will be assessed up until the study day 28 visit Serious adverse events will be captured throughout study follow-up and actively during the study day 180 visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None