A research study on Typhoid Conjugate Vaccine manufactured by Serum Institute for the treatment of Typhoid and Paratyphoid treatment in the Indian participants between 6 months to 65 years of age, to check the effect of Typhoid vaccine in Indian Participants.

A Phase 2/3, Double-Blind, Randomized, Active-Controlled, Multicentric study to evaluate the Safety, Immunogenicity and Lot-to-Lot consistency of a bivalent conjugate vaccine against Salmonella enterica serovars Typhi and Paratyphi A in healthy individuals aged 6 months to 65 years

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089129

Enrollment

2729

Registered

2025-06-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

None listed

Interventions

Intervention1: SII-TCV(B): A bivalent conjugate vaccine containing the Vi polysaccharide antigen from S. Typhi conjugated to purified tetanus toxoid (TT) carrier protein and the purified O-specific po

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female participants aged between more than 6 months to less than 65 years 2. Normal health as determined by medical history and clinical examination. 3. Intend to remain residing near study area throughout study participation. 4. Female participants of childbearing potential with negative pregnancy test prior to IP administration.

Exclusion criteria

Exclusion criteria: 1. History of S. Typhi or S. Paratyphi A infection. 2. Previous vaccination for typhoid fever 3. Planning to receive any vaccine until Day 29 post-vaccination. 4. Major congenital or genetic defect 5. Pregnant or lactating women 6. History or presence of significant alcoholism or drug abuse in the past one year.

Design outcomes

Primary

Measure	Time frame
1.Immediate adverse events within 30 minutes post-vaccination. 2.Solicited local and systemic adverse events up to Day 7 post-vaccinationTimepoint: 1. 30 minutes post-vaccination 2. Day 7 post-vaccination	—

Secondary

Measure	Time frame
To compare the safety and tolerability of SII-TCV( B) to Typbar-TCV .Timepoint: 1. IAEs within 30 minutes post-vaccination. 2. Solicited local and systemic AEs up to Day 7 postvaccination. 3. Unsolicited AEs up to Day 29 post-vaccination. 4. SAEs up to Day 181 post-vaccination	—

Countries

India

Contacts

Public ContactDr Prasad Kulkarni

Serum Institute of India Private, Pune

drpsk@seruminstitute.com912071946820

Outcome results