Typhoid FeverPhase 4VEVACTNCT05500482
Vellore Typhoid Vaccine Impact Trial
A Phase 4 study testing Typhoid conjugate Vaccine in people with Typhoid Fever, run by Christian Medical College, Vellore, India at 1 site in India.
Trial summary
This cluster randomised trial will examine the impact of introducing TyphiBEV, a typhoid conjugate vaccine licensed in India, on the incidence of typhoid fever in a high burden urban setting in South India. Read more about this study
- Who is it for?
- Ages 1 year to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Typhoid Fever
- What is being tested?
- Typhoid conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72,400 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2023to 28 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 1 year to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Consent
- For adults, 18 years and over - they must be willing and competent to provide informed consent
- For those aged under 18 years, the parent/guardian is willing and competent to provide informed consent, and if the participant is 11 to 18 years of age, informed assent will also be sought,
- Age:
- Between 1 and 30 years (i.e., up to 29 years 364 days) at time of recruitment into the surveillance
- Currently living within the study catchment area with no plans to leave the study area in the next 24 months
Who cannot join
- For fever surveillance
- o Medical reasons that prevent the participant from complying with study requirements including follow up and testing during illness
- For vaccination
- Has received a typhoid vaccine in the previous three years
- Is known to have an allergy to any vaccine component
- Nursing mothers, Pregnancy or planning pregnancy around vaccination
- Receipt of any other vaccine in the past 30 days (temporary exclusion)
- Febrile illness in the 24 hours before vaccination (temporary exclusion)
Trial locations and contacts
1 site in 1 country.
About this study
This cluster randomised trial will examine the impact of introducing TyphiBEV, a typhoid conjugate vaccine licensed in India, on the incidence of typhoid fever in a high burden urban setting in South India.
Read the detailed description
TyphiBEV®, a typhoid conjugate vaccine from Biological E, has been licensed by the Central Drugs Standard Control Organaisation in India based on immunogenicity and safety data. A similar typhoid conjugate vaccine has been demonstrated in large clinical trials to provide 80% vaccine efficacy in Nepal and Bangladesh. The TyphiBEV® has not been similarly evaluated. The demonstration of the impact of a city-scale typhoid conjugate vaccine introduction on the burden of typhoid will aid policy decisions on the use of typhoid conjugate vaccines in the national immunisation program.
After written informed consent, the investigators will establish stimulated passive surveillance in 72,000 individuals between 1 and 30 years of age within the Vellore Demographic Surveillance System to determine the incidence of blood-culture confirmed typhoid fever. Thirty-six thousand surveillance participants between 1 year and 30 years residing in the 30 clusters (areas) randomised to receive the vaccine will receive the vaccine at the beginning of the trial. Those in other areas will receive the same at the end of two years. Using a stimulated passive surveillance approach, those with acute febrile illness will be encouraged to visit study surveillance hospitals. Participants will be evaluated for blood-culture confirmed typhoid fever if they are eligible. The incidence of typhoid among those living in areas assigned to vaccination compared to those whose residence is in areas not designated for vaccination will be used to calculate the impact of the vaccine on disease burden.
- Conditions
- Typhoid Fever
- Being tested
- Typhoid conjugate Vaccine
- Keywords
- typhoid conjugate vaccine, cluster randomised trial, Enteric Fever
- Medical subject headings
- Typhoid Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typhoid conjugate VaccineBiological
Also called TyphiBEV
TyphiBEV is a clear colourless monovalent vaccine containing 25 µg of Typhoid Vi polysaccharide manufactured using the Citrobacter freundii sensu lato3056 (Vi) and is conjugated to CRM 197 as a carrier protein. Sodium chloride and Phosphate buffer are used as a buffering agent in the vaccine formulation with 2-Phenoxyethanol as a preservative.
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated arm | Experimental | Typhoid Conjugate Vaccine (TyphiBEV) 0.5 ml as a single dose given intramuscularly to consenting, eligible residents of vaccine clusters Receives: Biological: Typhoid conjugate Vaccine |
| Control arm | No intervention | No vaccination in the control clusters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total effect
Number of blood culture confirmed typhoid fever episodes in vaccinated participants from vaccine clusters compared to the number of blood culture confirmed typhoid fever episodes in unvaccinated participants from non-vaccine clusters
Measured: at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.
Secondary outcomes (4)
Overall effect
The number of blood culture confirmed typhoid fever episodes in participants from vaccine clusters compared to the number of blood culture confirmed typhoid fever episodes in participants from non-vaccine clusters
Measured: at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.
Effect in children 1 to 14 years
The number of blood culture confirmed typhoid fever episodes in vaccinated children between 1 year and 14 years and 364 days from vaccine clusters compared to the number of blood culture confirmed typhoid fever episodes in unvaccinated children between 1 year and 14 years and 364 days from non-vaccine clusters
Measured: at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.
Effect on all febrile illness requiring healthcare visits
The number of febrile illness episodes where healthcare is sought among vaccinated participants from vaccine clusters compared to unvaccinated participants from non-vaccine clusters
Measured: at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.
Safety outcomes
The number and description of solicited and non-solicited adverse events reported within the first seven days after vaccination in the safety subset of vaccine recipients
Measured: Seven days after vaccine receipt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 May 2023
- Primary completion31 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typhoid FeverStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Medical College, Vellore, India
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University College, London, Imperial College London
- Responsible party
- Principal investigator, Jacob John, Christian Medical College, Vellore, India
- Investigators
- Jacob John, MD PhD, Principal investigator, Christian Medical College, Vellore, IndiaGagandeep Kang, MD PhD, Study chair, Christian Medical College, Vellore, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500482
- Sponsor's protocol ID
- 14247[INTERVEN]
- Acronym
- VEVACT
- Status last verified
- Mar 2026
- First submitted
- 8 Aug 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual level data as permitted by the local law will be made available on Mendeley Data. Access to data will be possible by writing to the vevact@tympact.in on or after 31 Dec 2025
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vellore Typhoid Vaccine Impact Trial
- ClinicalTrials.gov ID
- NCT05500482
- Acronym / sponsor ID
- VEVACT / 14247[INTERVEN]
- Conditions
- Typhoid Fever
- Keywords
- typhoid conjugate vaccine, cluster randomised trial, Enteric Fever
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72,400 participants (actual)
- Lead sponsor
- Christian Medical College, Vellore, IndiaUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University College, London, Imperial College London
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 15 Aug 2022 (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 cluster randomised trial will examine the impact of introducing TyphiBEV, a typhoid conjugate vaccine licensed in India, on the incidence of typhoid fever in a high burden urban setting in South India.
Detailed description
TyphiBEV®, a typhoid conjugate vaccine from Biological E, has been licensed by the Central Drugs Standard Control Organaisation in India based on immunogenicity and safety data. A similar typhoid conjugate vaccine has been demonstrated in large clinical trials to provide 80% vaccine efficacy in Nepal and Bangladesh. The TyphiBEV® has not been similarly evaluated. The demonstration of the impact of a city-scale typhoid conjugate vaccine introduction on the burden of typhoid will aid policy decisions on the use of typhoid conjugate vaccines in the national immunisation program.
After written informed consent, the investigators will establish stimulated passive surveillance in 72,000 individuals between 1 and 30 years of age within the Vellore Demographic Surveillance System to determine the incidence of blood-culture confirmed typhoid fever. Thirty-six thousand surveillance participants between 1 year and 30 years residing in the 30 clusters (areas) randomised to receive the vaccine will receive the vaccine at the beginning of the trial. Those in other areas will receive the same at the end of two years. Using a stimulated passive surveillance approach, those with acute febrile illness will be encouraged to visit study surveillance hospitals. Participants will be evaluated for blood-culture confirmed typhoid fever if they are eligible. The incidence of typhoid among those living in areas assigned to vaccination compared to those whose residence is in areas not designated for vaccination will be used to calculate the impact of the vaccine on disease burden.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated arm | Experimental | Biological: Typhoid conjugate VaccineTyphoid Conjugate Vaccine (TyphiBEV) 0.5 ml as a single dose given intramuscularly to consenting, eligible residents of vaccine clusters |
| Control arm | No intervention | –No vaccination in the control clusters |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Consent
- Age:
Key exclusion criteria (8 listed)
- For fever surveillance
- o Medical reasons that prevent the participant from complying with study requirements including follow up and testing during illness
- For vaccination
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 |
|---|---|---|
| Typhoid conjugate VaccineAlso: TyphiBEVTyphiBEV is a clear colourless monovalent vaccine containing 25 µg of Typhoid Vi polysaccharide manufactured using the Citrobacter freundii sensu lato3056 (Vi) and is conjugated to CRM 197 as a carrier protein. Sodium chloride and Phosphate buffer are used as a buffering agent in the vaccine formulation with 2-Phenoxyethanol as a preservative. | Biological | Vaccinated arm |
Primary outcome
Total effect
Time frame: at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.
Number of blood culture confirmed typhoid fever episodes in vaccinated participants from vaccine clusters compared to the number of blood culture confirmed typhoid fever episodes in unvaccinated participants from non-vaccine clusters
4 secondary outcomes
Overall effect
Time frame: at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.
Effect in children 1 to 14 years
Time frame: at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.
Effect on all febrile illness requiring healthcare visits
Time frame: at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.
Safety outcomes
Time frame: Seven days after vaccine receipt
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Yes. All de-identified individual level data as permitted by the local law will be made available on Mendeley Data. Access to data will be possible by writing to the vevact@tympact.in on or after 31 Dec 2025
Related trials for Typhoid Fever
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Active, not recruitingPhase 3
Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
Typhoid
RecruitingPhase 4
CVD 38000: Study of Responses to Vaccination With Typhoid and/or Cholera
Typhoid and/or Cholera Vaccination
Not yet recruiting
COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE
Typhoid Fever
RecruitingPhase 4
Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever
Enteric Fever
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.
Jacob John, MD PhD principal investigator
Christian Medical College, Vellore, India
Gagandeep Kang, MD PhD study chair
Christian Medical College, Vellore, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Typhoid conjugate Vaccine in people with Typhoid Fever, run by Christian Medical College, Vellore, India at 1 site in India.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 17 Mar 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 India. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total effect (time frame: at 24 months of follow up beginning 28 days after vaccine introduction in vaccine clusters.). 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 17 Mar 2026.