A clinical study to vaccinate healthy adults with a single human dose of a licensed Typhoid Conjugate Vaccine and collection of immune sera for development of testing standards for anti- typhoid antibody estimation.

An open label study for Collection of Human Blood Sample for Development of Anti-Vi IgG testing standard, in process of developing a new Conjugate Vaccine for Typhoid Enteric fever caused by Salmonella Typhi - None

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/01/011500

Enrollment

Registered

2018-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z23- Encounter for immunization

Interventions

Intervention1: Licensed Typhoid Conjugate Vaccine.Single Human dose -0.5mL: 1. Dose: 0.5 mL single dose 2. Frequency: One dose only 3. Route of administration: intramuscular injection in deltoid muscl

Eligibility

Inclusion criteria

Inclusion criteria: 1. Provide voluntary written and signed informed consent from volunteer. 2. Healthy subjects aged 18 to 30 years of both gender. 3. Are not participating in or plan to participate in another research during the next three months & be available throughout study period. 4. Family does not plan to move during the study period, and housed not further that 50 KM away from the study site.

Exclusion criteria

Exclusion criteria: 1. Fever of any origin or infections more than 3 days within one month prior to screening or on the day of screening 2. Any confirmed or suspected immunosuppressive condition. 3. Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for typhoid. 4. In receipt of systemic immunosuppressant or systemic corticosteroids. 5. Prior or anticipated receipt of immune globulin or other blood products, or other immune modulator therapy. 6. Life threatening or serious cardiac, respiratory, gastrointestinal, hepatic, renal, endocrine and systemic disorders. 7. Have been vaccinated against typhoid fever or had exposure to typhoid fever within the last three years. 8. Suspected or known hypersensitivity to any of the investigational or marketed vaccine components. 9. Any condition that, in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the study objectives.

Design outcomes

Primary

Measure	Time frame
1.To collect immune sera samples from each enrolled subject.Timepoint: 1.Day 28 post single dose of vaccine administration.	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactDrTSA Kishore

Biological E.Limited

kishore.turaga@biologicale.com04030214046

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026