Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05784701
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-02-07
Brief Title:
Trivalent Salmonella Conjugate Vaccine TSCV
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Age-descending Randomized Placebo-controlled Phase 2 Trial in Three Sites in Sub-Saharan Africa to Assess the Safety and Immunogenicity of a Parenteral Trivalent Salmonella S EnteritidisS TyphimuriumS Typhi Vi Conjugate Vaccine TSCV Versus Placebo
Status:
RECRUITING
Status Verified Date:
2024-05
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 is an age-descending randomized placebo-controlled trial that will evaluate the safety and immunogenicity of a Trivalent Salmonella conjugate vaccine TSCV The trial will proceed from adults to children to toddlers and then to infants
Detailed Description:
This is an age-descending randomized placebo-controlled trial that will evaluate the safety and immunogenicity of a Trivalent Salmonella conjugate vaccine TSCV The trial will proceed from adults to children to toddlers and then to infants
In Step 1A-D of the trial participants will be randomized to receive a single dose of TSCV Full-strength or Half-strength Typbar-TCV or placebo first in adults then in children 5 to 9 years of age then children 24 to 59 months of age and then 16 to 23 months of age
Participants will be followed for 6 months After a Data Safety Monitoring Board DSMB review of the safety data the trial will proceed to Step 2A and 2B whereupon 12- to 16-month-old toddlers and infants 8- to 11-months of age will be similarly and simultaneously randomized Participants will be followed for 6 months
After another DSMB safety review Step 3 will commence with simultaneous enrollment of 12- to 14-week-old and 16- to 18-week-old infants who will each receive a single dose of TSCV TCV or placebo Participants will be followed for 6 months
After a third DSMB safety review and selection of the preferred TSCV formulation Full-strength versus Half-strength for further clinical development a decision taken by the Sponsor Manufacturer and funder while taking into consideration the recommendation of the DSMB Step 4 will evaluate a two-dose regimen Infants 12 to 18 weeks of age will be randomized to receive either two doses of TSCV at Full-strength or Half-strength based on results from Steps 1-3 or placebo followed by Typbar-TCV The priming dose will be administered at enrollment and the booster at 9 12 or 15-17 months of age
Participants will be followed until 6 months after the last study vaccination
Note -- Whenever investigational products are intended to be administered at a scheduled Expanded Program on Immunization visit they will always be given 2 weeks after the routine EPI vaccines This will not only avoid interference with EPI vaccines but will provide a convenient contact point for potential recruitment of participants for the study
In Step 1A-D of the trial participants will be randomized to receive a single dose of TSCV Full-strength or Half-strength Typbar-TCV or placebo first in adults then in children 5 to 9 years of age then children 24 to 59 months of age and then 16 to 23 months of age
Participants will be followed for 6 months After a Data Safety Monitoring Board DSMB review of the safety data the trial will proceed to Step 2A and 2B whereupon 12- to 16-month-old toddlers and infants 8- to 11-months of age will be similarly and simultaneously randomized Participants will be followed for 6 months
After another DSMB safety review Step 3 will commence with simultaneous enrollment of 12- to 14-week-old and 16- to 18-week-old infants who will each receive a single dose of TSCV TCV or placebo Participants will be followed for 6 months
After a third DSMB safety review and selection of the preferred TSCV formulation Full-strength versus Half-strength for further clinical development a decision taken by the Sponsor Manufacturer and funder while taking into consideration the recommendation of the DSMB Step 4 will evaluate a two-dose regimen Infants 12 to 18 weeks of age will be randomized to receive either two doses of TSCV at Full-strength or Half-strength based on results from Steps 1-3 or placebo followed by Typbar-TCV The priming dose will be administered at enrollment and the booster at 9 12 or 15-17 months of age
Participants will be followed until 6 months after the last study vaccination
Note -- Whenever investigational products are intended to be administered at a scheduled Expanded Program on Immunization visit they will always be given 2 weeks after the routine EPI vaccines This will not only avoid interference with EPI vaccines but will provide a convenient contact point for potential recruitment of participants for the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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