A Study to evaluate the Safety, Immunogenicity, and Immune Non-Interference of a Typhoid Vaccine in healthy infants aged 9 to 12 months

A Phase 2/3, double-blind, randomized, active-controlled study to evaluate the safety, immunogenicity, and immune non-Interference of a Bivalent Conjugate Vaccine against Salmonella Enterica Serovars Typhi and Paratyphi A in healthy infants aged 9 to 12 months

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202507569845862

Enrollment

651

Registered

2025-07-24

Start date

2025-03-03

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

Typhoid Fever

Interventions

Typbar Typhoid Conjugate Vaccine

SII Typhoid Conjugate Vaccine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female participants aged between = 9 to <12 months 2. Normal health as determined by medical history and clinical examination. 3. Parent of participant willing to give written informed consent and to adhere to the protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Fever (= 37.5oC on axillary temperature) or any acute clinically significant infection at the time of vaccination. 2. Experienced significant acute, or chronic infections requiring systemic antibiotic treatment within the past 14 days. 3. History of S. Typhi or S. Paratyphi A infection. 4. Planning to receive any vaccine until Day 29 post-vaccination. 5. Presence of significant malnutrition (weight-for-length z-score < -3SD) 6. Major congenital or genetic defect 7. Any other condition which in the opinion of the investigator will jeopardize the safety of the participant or compromise the assessment of study objectives.

Design outcomes

Primary

Measure	Time frame
Occurrence of immediate adverse events (IAEs) within 30 minutes post-vaccination, solicited adverse events (AEs) up to Day 7 post-vaccination, unsolicited AEs and SAEs up to Day 29 post-vaccination.	—

Secondary

Measure	Time frame
Occurrence of IAEs within 30 minutes post-vaccination, Solicited AEs up to Day 7 post-vaccination, unsolicited AEs up to Day 29 post-vaccination, and SAEs up to Day 181 post-vaccination.	—

Countries

Kenya

Contacts

Public ContactPrasad Kulkarni

Executive Director

drpsk@seruminstitute.com+912071946820

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026