A study to evaluate the safety, effectiveness, and long-term protection (effectiveness) of typhoid vaccines in healthy Indian participants aged 6 months to 2 years.

An Open-label, Randomized Study to Assess the Safety, immunogenicity and Long-term Immune persistence of the licensed typhoid conjugate vaccines in Healthy Indian Participants Aged greater than or equal to 6 months to less than or equal to 2 years. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108624

Enrollment

225

Registered

2026-04-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

None listed

Interventions

Intervention1: Typbar-TCV : Purified Vi-Capsular Polysaccharide of S. Typhi Ty2 conjugated to Tetanus Toxoid: 25 g Sodium chloride BP: 4.5 mg Water for Injection BP: q.s to 0.5 mL Duration: Single D

Eligibility

Inclusion criteria

Inclusion criteria: 1. The participant should be healthy and aged between greater than or equal to 6 months to less than or equal to 2 years at enrollment. 2. No previous documented history of receipt of the typhoid vaccine. 3. Participants are not currently participating in any other clinical trial or have received any other investigational product in the last six months 4. Participant(s) parents or legally acceptable representative (LAR) are willing to sign the informed consent 5. Participant(s) parents or LAR and the participant intend to remain in the same area during the study period

Exclusion criteria

Exclusion criteria: 1. Acute medical illness with or without fever within the last 72 hours or an axillary temperature greater than or equals to 37.5 C at enrolment [temporary exclusion, till a febrile]. 2. Known or suspected impairment of immunologic function. 3. In receipt of systemic immunosuppressant or systemic corticosteroids. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial if they have not received more than one course within the last 2 weeks before enrolment. Prior or anticipated receipt of immune globulin or other blood products or other immune modulator therapy, except for routine vaccines, within 6 weeks of administration of the study vaccines. 4. Suspected or known hypersensitivity to any of the investigational or marketed vaccine components

Design outcomes

Primary

Measure	Time frame
GMTs of serum anti-Vi antibodies at baseline (day 0) and subsequent post vaccination study visits at days 28 2, 180 7, 360 30 in the treatment groups.Timepoint: days 28 2, 180 7, 360 30	—

Secondary

Measure	Time frame
1) The proportion of study participants attaining seroconversion of anti Vi antibodies (greater than four-fold rise in antibody titre compared to baseline) after 28+2, 180 7, 360 30, vaccine administration in the treatment groups 2) To record and document immediate adverse events within 30 minutes after vaccination. 3) To record and document solicited local and systemic adverse events during the 7-day follow-up period after vaccinationTimepoint: days 28 2, 180 7, 360 30 and adverse events during the 7 day follow up period after vaccination	—

Measure

Time frame

1) The proportion of study participants attaining seroconversion of anti Vi antibodies (greater than four-fold rise in antibody titre compared to baseline) after 28+2, 180 7, 360 30, vaccine administration in the treatment groups 2) To record and document immediate adverse events within 30 minutes after vaccination. 3) To record and document solicited local and systemic adverse events during the 7-day follow-up period after vaccinationTimepoint: days 28 2, 180 7, 360 30 and adverse events during the 7 day follow up period after vaccination

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Countries

India

Contacts

Public ContactDr Sanjay Pandey

All India Institute of Medical Sciences, Patna

drsanjaypanday72@gmail.com7783892746

Outcome results