Last reviewed 2026-05-22 · How we verify

Vi-DT (Multi-dose formulation)

International Vaccine Institute · Phase 3 active Biologic ✓ Verified May 2026

Vi-DT (Multi-dose formulation) is a vaccine Biologic drug developed by International Vaccine Institute. It is currently in Phase 3 development for Prevention of typhoid fever. Also known as: Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein.

Vi-DT is a vaccine that stimulates the immune system to produce antibodies against a specific target.

Vi-DT (Multi-dose formulation) is a small molecule vaccine used to study immune equivalence against Typhoid. It is being compared to a single dose formulation and a control vaccine in a Phase III clinical trial (NCT04204096) to evaluate its safety and immune response.

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Vi-DT (Multi-dose formulation)
Also known as	Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein
Sponsor	International Vaccine Institute
Drug class	vaccine
Target	Salmonella Typhi O:1a
Modality	Biologic
Therapeutic area	Infectious Diseases
Phase	Phase 3

Mechanism of action

The exact mechanism of Vi-DT is not fully understood, but it is believed to work by inducing a strong immune response against the O:1a serotype of Salmonella Typhi, the bacteria that causes typhoid fever. This immune response is thought to provide long-term protection against typhoid fever.

Approved indications

Prevention of typhoid fever

Common side effects

Pain, redness, or swelling at the injection site

Key clinical trials

Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III) (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Vi-DT (Multi-dose formulation) CI brief — competitive landscape report
Vi-DT (Multi-dose formulation) updates RSS · CI watch RSS
International Vaccine Institute portfolio CI

Frequently asked questions about Vi-DT (Multi-dose formulation)

What is Vi-DT (Multi-dose formulation)?

Vi-DT (Multi-dose formulation) is a vaccine drug developed by International Vaccine Institute, indicated for Prevention of typhoid fever.

How does Vi-DT (Multi-dose formulation) work?

Vi-DT is a vaccine that stimulates the immune system to produce antibodies against a specific target.

What is Vi-DT (Multi-dose formulation) used for?

Vi-DT (Multi-dose formulation) is indicated for Prevention of typhoid fever.

Who makes Vi-DT (Multi-dose formulation)?

Vi-DT (Multi-dose formulation) is developed by International Vaccine Institute (see full International Vaccine Institute pipeline at /company/international-vaccine-institute).

Is Vi-DT (Multi-dose formulation) also known as anything else?

Vi-DT (Multi-dose formulation) is also known as Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein.

What drug class is Vi-DT (Multi-dose formulation) in?

Vi-DT (Multi-dose formulation) belongs to the vaccine class. See all vaccine drugs at /class/vaccine.

What development phase is Vi-DT (Multi-dose formulation) in?

Vi-DT (Multi-dose formulation) is in Phase 3.

What are the side effects of Vi-DT (Multi-dose formulation)?

Common side effects of Vi-DT (Multi-dose formulation) include Pain, redness, or swelling at the injection site.

What does Vi-DT (Multi-dose formulation) target?

Vi-DT (Multi-dose formulation) targets Salmonella Typhi O:1a and is a vaccine.

Drug class: All vaccine drugs
Target: All drugs targeting Salmonella Typhi O:1a
Manufacturer: International Vaccine Institute — full pipeline
Therapeutic area: All drugs in Infectious Diseases
Indication: Drugs for Prevention of typhoid fever
Also known as: Vi polysaccharide typhoid vaccine conjugated with Diphtheria toxoid protein

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing