Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03299426
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2017-09-27
Brief Title:
Clinical Efficacy of Typhoid Conjugate Vaccine Vi-TCV Among Children Age 9 Months Through 12 Years in Blantyre Malawi
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase III Randomized Double-Blind Controlled Trial of the Clinical Efficacy of Typhoid Conjugate Vaccine Vi-TCV Among Children Age 9 Months Through 12 Years in Blantyre Malawi
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
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 11 ration to receive the study vaccine or the control vaccine meningococcal group A conjugate vaccine - MCV-A
Detailed Description:
This study is a double-blind individually randomized controlled clinical efficacy trial with two vaccine groups Vi-TCV Typhoid conjugate and MCV-A meningococcal group A conjugate This study will take place in Blantyre Malawi Africa Participants up to 30000 will be randomized in a 11 ratio Children 9 months through 12 years of age in the Blantyre area who meet the inclusion criteria will be eligible for enrollment
Participants will be unaware of which study vaccine Vi-TCV or MCV-A is received A subset of 600 children will have study visits on days 3 7 28 and 180 post-vaccination to assess select solicited events unsolicited events and all serious adverse events Serious Adverse Events SAEs in all participants will be monitored through the end of the trial
For the evaluation of efficacy passive surveillance will be conducted for up to 36 months to identify cases among vaccinated subjects Children who meet the protocol-defined specimen collection criteria will have a blood culture collected Additional information will be collected from any child who has a blood culture obtained This will include information about the signs and symptoms of the illness and treatment given Likewise any child with blood culture-confirmed typhoid fever will have follow-up until the illness resolves Additional information on the illness treatment and complications will be recorded Vaccine efficacy will be evaluated when the pre-specified number of cases is reached after a minimum of two years of follow-up on each participant
A subset of 600 children 200 in each of three age groups 9-11 months 1-5 years and 6-12 years will be included in an additional Vaccine Immunogenicity and Reactogenicity Sub-study More stringent exclusion criteria will apply for this subset The purpose of this detailed evaluation is to assess the reactogenicity of the vaccine and the immune responses to Vi-TCV Serum specimens will be collected on day 0 before vaccination and on post-vaccination days 28 and 730 from all children included in the sub-study For the children in the 9-11 month group Vi-TCV or MCV-A will be administered with measles-containing vaccine as per Malawi Expanded Programme on Immunization EPI schedule These 9-11-month-old children will have antibody to measles assessed on days 0 and 28 All children in the sub-study will have visits at days 4 and 7 following vaccination for solicitation of local and systemic adverse events Serious and non-serious adverse events will be assessed at days 28 and 180
An additional subset of -up to 225 HIV-exposed-but-uninfected and up to 100 HIV-unexposed children ages 9-11 months will be included in an additional HIV-exposed Vaccine Immunogenicity and Reactogenicity Substudy The purpose of this detailed evaluation is to assess the reactogenicity of the vaccine and the immune responses to one or two doses of Vi-TCV in HIV-exposed children Up to 225 HIV-exposed children in this substudy will be randomized 111 to receive either TCV at 9-11 months and TCV at 15 months Group 1 TCV at 9-11 months only Group 2 or TCV at 15 months only Group 3 A separate group of about 100 HIV-unexposed children will serve as controls and receive TCV at 9-11 months and TCV at 15 months Group 4 Serum specimens will be collected on day 0 before vaccination and on 28 days after each vaccination from all children included in the sub-study For this substudy Vi-TCV will be administered with measles-rubella-containing vaccine 1 at 9-11 months andor 2 at 15 months as per Malawi EPI schedule These 9-11-month-old children will have antibody to typhoid measles and rubella assessed on day 0 and 28 days after each vaccination All children in the sub-study will be assessed at 7 days after each vaccination for solicitation of local and systemic adverse events Serious and non-serious adverse events will be assessed up to the last study visit for HIV-exposed substudy participants
Participants will be unaware of which study vaccine Vi-TCV or MCV-A is received A subset of 600 children will have study visits on days 3 7 28 and 180 post-vaccination to assess select solicited events unsolicited events and all serious adverse events Serious Adverse Events SAEs in all participants will be monitored through the end of the trial
For the evaluation of efficacy passive surveillance will be conducted for up to 36 months to identify cases among vaccinated subjects Children who meet the protocol-defined specimen collection criteria will have a blood culture collected Additional information will be collected from any child who has a blood culture obtained This will include information about the signs and symptoms of the illness and treatment given Likewise any child with blood culture-confirmed typhoid fever will have follow-up until the illness resolves Additional information on the illness treatment and complications will be recorded Vaccine efficacy will be evaluated when the pre-specified number of cases is reached after a minimum of two years of follow-up on each participant
A subset of 600 children 200 in each of three age groups 9-11 months 1-5 years and 6-12 years will be included in an additional Vaccine Immunogenicity and Reactogenicity Sub-study More stringent exclusion criteria will apply for this subset The purpose of this detailed evaluation is to assess the reactogenicity of the vaccine and the immune responses to Vi-TCV Serum specimens will be collected on day 0 before vaccination and on post-vaccination days 28 and 730 from all children included in the sub-study For the children in the 9-11 month group Vi-TCV or MCV-A will be administered with measles-containing vaccine as per Malawi Expanded Programme on Immunization EPI schedule These 9-11-month-old children will have antibody to measles assessed on days 0 and 28 All children in the sub-study will have visits at days 4 and 7 following vaccination for solicitation of local and systemic adverse events Serious and non-serious adverse events will be assessed at days 28 and 180
An additional subset of -up to 225 HIV-exposed-but-uninfected and up to 100 HIV-unexposed children ages 9-11 months will be included in an additional HIV-exposed Vaccine Immunogenicity and Reactogenicity Substudy The purpose of this detailed evaluation is to assess the reactogenicity of the vaccine and the immune responses to one or two doses of Vi-TCV in HIV-exposed children Up to 225 HIV-exposed children in this substudy will be randomized 111 to receive either TCV at 9-11 months and TCV at 15 months Group 1 TCV at 9-11 months only Group 2 or TCV at 15 months only Group 3 A separate group of about 100 HIV-unexposed children will serve as controls and receive TCV at 9-11 months and TCV at 15 months Group 4 Serum specimens will be collected on day 0 before vaccination and on 28 days after each vaccination from all children included in the sub-study For this substudy Vi-TCV will be administered with measles-rubella-containing vaccine 1 at 9-11 months andor 2 at 15 months as per Malawi EPI schedule These 9-11-month-old children will have antibody to typhoid measles and rubella assessed on day 0 and 28 days after each vaccination All children in the sub-study will be assessed at 7 days after each vaccination for solicitation of local and systemic adverse events Serious and non-serious adverse events will be assessed up to the last study visit for HIV-exposed substudy participants
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?:
False
Is an FDA AA801 Violation?:
None