Trivalent Salmonella Conjugate Vaccine (TSCV)Phase 2NCT05784701
Trivalent Salmonella Conjugate Vaccine (TSCV)
A Phase 2 study testing TSCV (Full-strength), TSCV (Half-strength) and Typbar-TCV in people with Trivalent Salmonella Conjugate Vaccine (TSCV), run by University of Maryland, Baltimore at 1 site in Mali.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 weeks to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Trivalent Salmonella Conjugate Vaccine (TSCV)
- What is being tested?
- TSCV (Full-strength), TSCV (Half-strength) and Typbar-TCV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteMali
- Study dates
- 5 Apr 2023to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 weeks to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy individuals, female or male
- Age (all age ranges are inclusive)
- Step 1A: Adults 20-35 years of age
- Step 1B: Children, 5-9 years of age
- Step 1 C: Pre-school children, 24-59 mos. of age
- Step 1D: Older toddlers, 16-23 months of age
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- Step 2A: Young toddlers, 12-16 months of age
- Step 2B: Older infants, 8-11 months of age
- Step 3: Young infants,12-14 weeks of age OR 16-18 weeks of age
- Step 4: Young infants, 12-18 weeks of age
- For potential pediatric participants, the parents must live within the catchment area of the clinical study facility at the time of the study vaccinations and must intend to continue to reside in the area for the duration of the study
- Adult subjects and parents/ guardians of pediatric subjects must have provided informed consent
- Infant and toddler subjects in Steps 2, 3, and 4 must have received their scheduled EPI vaccines at least 14 days prior to receiving a study product.
Who cannot join
- A history of documented hypersensitivity to any component of the Trivalent Salmonella Conjugate Vaccine or of Typbar-TCV™
- A history of previous vaccination with any licensed or experimental typhoid vaccine A known history of diabetes, tuberculosis, malignancy, chronic kidney disease, cardiac disease, liver disease, progressive neurological disorder, poorly controlled seizure disorder, or a terminal illness based on participant interview and review of screening laboratory results.
- Severe malnutrition: i.e., weight-for-length Z-score of less than - 3.
- Receipt of any other investigational intervention in the last 6 months
- Known HIV infection or other forms of immunocompromise
- Receipt of systemic immunosuppressive medication including systemic corticosteroids
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- For Step 1A, for females of child-bearing potential, a positive pregnancy test at the time of enrollment.
- For Step 1B, any female child who has experienced menarche.
- Acute illness with or without fever (temperature >38.0oC) is a temporary exclusion criterion. Enrollment may be postponed until 3 days after the illness has resolved.
- Positive malaria test is a temporary exclusion criterion. Participant may be enrolled 3 days after completing treatment.
- Any condition determined by the investigators to be likely to interfere with evaluation of the vaccine, to be a significant health risk to the participant, or to make it unlikely that the participant would complete the study
Trial locations and contacts
1 site in 1 country.
About this study
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. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine (TSCV) Versus Placebo
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.
Read the 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.
- Being tested
- TSCV (Full-strength), TSCV (Half-strength), Typbar-TCV, Placebo
- Keywords
- S. Enteritidis, S. Typhimurium, S. Typhi Vi, Trivalent Salmonella Conjugate Vaccine (TSCV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSCV (Full-strength)Drug
TSCV (Full-strength)
TSCV (Half-strength)Drug
TSCV (Half-strength)
Typbar-TCVDrug
Typbar-TCV
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TSCV (Full-strength) | Active comparator | Full-strength GMP formulation of Trivalent Salmonella Conjugate Vaccine (TSCV) Receives: Drug: TSCV (Full-strength) |
| TSCV (Half-strength) | Active comparator | Half-strength GMP formulation of TSCV Receives: Drug: TSCV (Half-strength) |
| Typbar-TCV | Active comparator | Licensed Monovalent Typbar-TCV Receives: Drug: Typbar-TCV |
| Placebo | Placebo comparator | PBS Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Through day 29 post vaccination
Non-inferiority analysis: immunogenicity of Full-strength vs. Half-strength TSCV
Serum IgG anti-Vi antibodies
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At day 29 post booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start5 Apr 2023
- Primary completion5 Jan 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trivalent Salmonella Conjugate Vaccine (TSCV)Studies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Bharat Biotech International, Wellcome Trust
- Responsible party
- Principal investigator, Milagritos Tapia, University of Maryland, Baltimore
- Investigators
- Miligritos Tapia, MD, Principal investigator, University of Maryland Center for Vaccine Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784701
- Sponsor's protocol ID
- HP-00103997
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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. Enteritidis/S. Typhimurium/S. Typhi Vi) Conjugate Vaccine (TSCV) Versus Placebo
- ClinicalTrials.gov ID
- NCT05784701
- Acronym / sponsor ID
- HP-00103997
- Keywords
- S. Enteritidis, S. Typhimurium, S. Typhi Vi, Trivalent Salmonella Conjugate Vaccine (TSCV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Bharat Biotech International, Wellcome Trust
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TSCV (Full-strength) | Active comparator | Drug: TSCV (Full-strength)Full-strength GMP formulation of Trivalent Salmonella Conjugate Vaccine (TSCV) |
| TSCV (Half-strength) | Active comparator | Drug: TSCV (Half-strength)Half-strength GMP formulation of TSCV |
| Typbar-TCV | Active comparator | Drug: Typbar-TCVLicensed Monovalent Typbar-TCV |
| Placebo | Placebo comparator | Drug: PlaceboPBS |
Who may qualify
- Ages
- 12 weeks to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Healthy individuals, female or male
- Age (all age ranges are inclusive)
- For potential pediatric participants, the parents must live within the catchment area of the clinical study facility at the time of the study vaccinations and must intend to continue to reside in the area for the duration of the study
- Adult subjects and parents/ guardians of pediatric subjects must have provided informed consent
- Infant and toddler subjects in Steps 2, 3, and 4 must have received their scheduled EPI vaccines at least 14 days prior to receiving a study product.
Key exclusion criteria (11 listed)
- A history of documented hypersensitivity to any component of the Trivalent Salmonella Conjugate Vaccine or of Typbar-TCV™
- A history of previous vaccination with any licensed or experimental typhoid vaccine A known history of diabetes, tuberculosis, malignancy, chronic kidney disease, cardiac disease, liver disease, progressive neurological disorder, poorly controlled seizure disorder, or a terminal illness based on participant interview and review of screening laboratory results.
- Severe malnutrition: i.e., weight-for-length Z-score of less than - 3.
- Receipt of any other investigational intervention in the last 6 months
- Known HIV infection or other forms of immunocompromise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TSCV (Full-strength)TSCV (Full-strength) | Drug | TSCV (Full-strength) |
| TSCV (Half-strength)TSCV (Half-strength) | Drug | TSCV (Half-strength) |
| Typbar-TCVTypbar-TCV | Drug | Typbar-TCV |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Safety and reactogenicity of Full-strength and Half-strength TSCV
Time frame: first 30 minutes after parenteral immunization
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
Safety and reactogenicity of Full-strength and Half-strength TSCV
Time frame: over 7 days post-vaccination.
The proportion of participants in each product group and within each age group who develop adverse events (AEs) in the 7 days post-vaccination.
Safety and reactogenicity of Full-strength and Half-strength TSCV
Time frame: through Day 29 of follow-up post-vaccination
The proportion of participants who experience AEs through Day 29 of follow-up post-vaccination.
Safety and reactogenicity of Full-strength and Half-strength TSCV
Time frame: Through Day 366 of follow-up post vaccination
The proportion of participants who experience Serious Adverse Events through their participation in the study.
Non-inferiority analysis: immunogenicity of Full-strength vs. Half-strength TSCV
Time frame: Through day 29 post vaccination
Serum IgG anti-COPS antibodies (to both S. Enteritidis and S. Typhimurium antigens)
Non-inferiority analysis: immunogenicity of Full-strength vs. Half-strength TSCV
Time frame: Through day 29 post vaccination
Serum IgG anti-Vi antibodies
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)]
Time frame: over 7 days post-vaccination.
The proportion of participants in each product group who develop adverse events (AEs) in 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)]
Time frame: through Day 29 of follow-up after each vaccination.
The proportion of participants who experience AEs 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)]
Time frame: Until the end of the participant study period - 6 months to 1 year post vaccination
The proportion of participants who experience Serious Adverse Events through their participation in the study.
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
Time frame: At day 29 post booster vaccination
The rates of seroconversion of serum IgG anti-COPS at each booster age group
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
Time frame: At day 29 post booster vaccination
The geometric mean titers of serum IgG anti-COPS at each booster age group
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
Time frame: At day 29 post booster vaccination
The increases in geometric mean-fold titers from day 1 to 29 of serum IgG anti-COPS at each booster age group
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
Time frame: At day 29 post booster vaccination
The rates of persisting seroconversion (titers remaining > 4-fold above Day 1) of serum IgG anti-COPS at each booster age group
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
Time frame: At day 29 post booster vaccination
The rates of seroconversion of serum IgG anti-Vi at each booster age group
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
Time frame: At day 29 post booster vaccination
The geometric mean titers of serum IgG anti-Vi at each booster age group
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
Time frame: At day 29 post booster vaccination
The increases in geometric mean-fold titers from day 1 to 29 of serum IgG anti-Vi at each booster age group
Immunogenicity of two-dose regimen of TSCV [At each booster age group (9, 12 or 15-17 months of age)]
Time frame: At day 29 post booster vaccination
The rates of persisting seroconversion (titers remaining > 4-fold above Day 1) of serum IgG anti-Vi at each booster age group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miligritos Tapia, MD principal investigator
University of Maryland Center for Vaccine Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TSCV (Full-strength), TSCV (Half-strength) and Typbar-TCV in people with Trivalent Salmonella Conjugate Vaccine (TSCV), run by University of Maryland, Baltimore at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and reactogenicity of Full-strength and Half-strength TSCV (time frame: first 30 minutes after parenteral immunization). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.