TypbarTCV-Typhoid vaccine Phase-IV clinical trial Compare to Sanofi Pasteurâ??s Typhim ViÂ® vaccine.

A randomized, open label, multi-center study to compare the safety and immunogenicity of BBILâ??s Typbar-TCVâ?¢ to Sanofi Pasteurâ??s Typhim ViÂ®, administered intramuscularly to subjects aged 2 to 15 years - Typbar-TCV

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/01/006476

Enrollment

340

Registered

2016-01-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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-TCVÂ®: A single human dose vial of Typbar-TCVâ?¢ of 0.5mL, containing 25Î¼g purified Vi-capsular polysaccharide of S.Typhi Ty2 conjugated to tetanus toxoid - Intramuscularly Cont

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy subjects aged between 2 to 15 years at the time of enrollment. 2. Subject has not previously been documented to have received a typhoid vaccine. 3. Subjects are not currently participating in any other clinical trial or are in receipt of any other investigational product in the last 06 months 4. Subject parents or legally acceptable representative (LAR) is willing and able to provide, audio-video recorded and signed, informed consent. 5. Subject parents or family and the subject intend to remain in the area during the study period and be available for follow up.

Exclusion criteria

Exclusion criteria: 1.Acute medical illness with or without fever within the last 72 hours or an axillary temperature >=37.5Â°C at the time of enrolment [temporary exclusion, till a febrile]. 2.Known or suspected impairment of immunologic function. 3.In receipt of systemic immunosuppressant or systemic cortico-steroids. Individuals on a tapering dose schedule of oral steroids lasting 4.Suspected or known hypersensitivity to any of the investigational or marketed vaccine components. 5.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
To demonstrate non-inferiority of the immune response of Typbar-TCVâ?¢ as compared to Typhim ViÂ®, 28 days after vaccine administrationTimepoint: 28 days	—

Secondary

Measure	Time frame
The proportion of subjects attaining seroconversion of anti-Vi antibodies (more than fourfold rise in antibody titre compared to baseline), 90 days after vaccine administration in both treatment groupsTimepoint: 90 days	—

Countries

India

Contacts

Public ContactDr Binod Sah

Bharat Biotech International Ltd

binod3161@bharatbiotech.com04023480567

Outcome results