A Phase 2 interventional study of TSCV (Full-strength) and TSCV (Half-strength) in Trivalent Salmonella Conjugate Vaccine (TSCV), sponsored by University of Maryland, Baltimore. Active, not recruiting at 1 site in Mali. Open to participants aged 12 Weeks to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by University of Maryland, Baltimore · Phase 2, Interventional, and Other
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.
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.
University of Maryland, Baltimore is the lead sponsor of 700 studies on the registry; 132 are open to participants now.
Of its 92 completed or terminated interventional studies of FDA-regulated products, 66 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age (all age ranges are inclusive)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Full-strength GMP formulation of Trivalent Salmonella Conjugate Vaccine (TSCV)
Drug: TSCV (Full-strength)
Half-strength GMP formulation of TSCV
Drug: TSCV (Half-strength)
Licensed Monovalent Typbar-TCV
Drug: Typbar-TCV
PBS
Drug: Placebo
TSCV (Full-strength)
TSCV (Half-strength)
Typbar-TCV
Placebo
Safety and reactogenicity of Full-strength and Half-strength TSCV
The proportion of participants in each product group and within each age group who develop adverse events (AEs) in the first 30 minutes after parenteral immunization
Time frame: first 30 minutes after parenteral immunization
Safety and reactogenicity of Full-strength and Half-strength TSCV
The proportion of participants in each product group and within each age group who develop adverse events (AEs) in the 7 days post-vaccination.
Time frame: over 7 days post-vaccination.
Safety and reactogenicity of Full-strength and Half-strength TSCV
The proportion of participants who experience AEs through Day 29 of follow-up post-vaccination.
Time frame: through Day 29 of follow-up post-vaccination
Safety and reactogenicity of Full-strength and Half-strength TSCV
The proportion of participants who experience Serious Adverse Events through their participation in the study.
Time frame: Through Day 366 of follow-up post vaccination
Non-inferiority analysis: immunogenicity of Full-strength vs. Half-strength TSCV
Serum IgG anti-COPS antibodies (to both S. Enteritidis and S. Typhimurium antigens)
Time frame: Through day 29 post vaccination
Non-inferiority analysis: immunogenicity of Full-strength vs. Half-strength TSCV
Serum IgG anti-Vi antibodies
Time frame: Through day 29 post vaccination
Safety and reactogenicity after primary dose of TSCV and after booster dose of TSCV or Typbar-TCV™ [At each booster age group (9, 12, or 15-17 mo. of age)]
The proportion of participants in each product group who develop adverse events (AEs) in 7 days post-vaccination.
Time frame: over 7 days post-vaccination.
Safety and reactogenicity after primary dose of TSCV and after booster dose of TSCV or Typbar-TCV™ [At each booster age group (9, 12, or 15-17 mo. of age)]
The proportion of participants who experience AEs through Day 29 of follow-up after each vaccination.
Time frame: through Day 29 of follow-up after each vaccination.
Safety and reactogenicity after primary dose of TSCV and after booster dose of TSCV or Typbar-TCV™ [At each booster age group (9, 12, or 15-17 mo. of age)]
The proportion of participants who experience Serious Adverse Events through their participation in the study.
Time frame: Until the end of the participant study period - 6 months to 1 year post vaccination
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
The rates of seroconversion of serum IgG anti-COPS at each booster age group
Time frame: At day 29 post booster vaccination
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
The geometric mean titers of serum IgG anti-COPS at each booster age group
Time frame: At day 29 post booster vaccination
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
The increases in geometric mean-fold titers from day 1 to 29 of serum IgG anti-COPS at each booster age group
Time frame: At day 29 post booster vaccination
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
The rates of persisting seroconversion (titers remaining \> 4-fold above Day 1) of serum IgG anti-COPS at each booster age group
Time frame: At day 29 post booster vaccination
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
The rates of seroconversion of serum IgG anti-Vi at each booster age group
Time frame: At day 29 post booster vaccination
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
The geometric mean titers of serum IgG anti-Vi at each booster age group
Time frame: At day 29 post booster vaccination
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
The increases in geometric mean-fold titers from day 1 to 29 of serum IgG anti-Vi at each booster age group
Time frame: At day 29 post booster vaccination
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
The rates of persisting seroconversion (titers remaining \> 4-fold above Day 1) of serum IgG anti-Vi at each booster age group
Time frame: At day 29 post booster vaccination
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Jan 2027, 45 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Maryland, Baltimore →