To determine long term persistence of immune response of Typbar TCV

AN EXTENSION OF BBIL/TCV/IV-3/2015 PHASE 4 CLINICAL TRIAL OF TYPBAR TCVÂ®WITH COMPARATOR TYPHIM ViÂ®: TO DETERMINE THE LEVEL OF ANTI-SALMONELLA TYPHI VI POLYSACCHARIDE IGG ANTIBODIES AT THE END OF APPROXIMATELY 2 YEARS 6 MONTHS AND FOLLOW UP OF A BOOSTER DOSE OF TYPBAR TCVÂ® DOSE IN THOSE WHO HAVE LOWER LEVEL OF ANTIBODIES (BELOW CORRELATE OF PROTECTION) IN HEALTHY PRIMED AND BOOSTER DOSE RECEIVED CHILDREN - Typbar TCV with Typhim Vi

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018634

Enrollment

340

Registered

2019-04-15

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-TCV: O.5 ml Typbar TCV administered at DAY 0 Intervention2: Typbar TCV: 0.5 ml by intramuscular route Control Intervention1: Typhim Vi: 0.5 ml by intramuscular route

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy primed children who participated in BBIL/TCV/IV-3/2015 phase 4 clinical trial (Initiated: January 2016) 2.For minor subjects whose parent or guardian is able to understand planned study procedures comprehend and will comply with the requirements of the protocol procedures 3.Written informed consent obtained from subjects parent or guardian (if minor) prior to performance of any study specific procedure 4.Generally healthy subjects without acute or chronic, clinically significant pulmonary cardiovascular hepatic or renal functional abnormality as determined by physical examination

Exclusion criteria

Exclusion criteria: 1.Primed and boostered subjects whose anti-salmonella Vi-polysaccharide IgGtiter are found to be >2Âµg/mL. 2.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines or vaccines as per UIP schedule during the study period. 3.Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product for typhoid). 4.Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab) at any time during the study period. 5.Any confirmed or suspected immunosuppressive or immune-deficient condition, based on medical history and physical examination (e.g. Severe Combined Immunodeficiency Disease). 6.Subject with history of hypersensitivity to the vaccine or any of its composition or a present or past history of allergic reactions 7.Subjects suffering from acute or chronic infections or any other serious liver, renal, cardiac, respiratory or metabolic disease 8.Subjects with uncontrolled epilepsy or other progressive diseases of nervous system 9.Subjects unwilling to comply with the study procedures 10.Infection with Human Immunodeficiency Virus (HIV) regardless of clinical stage of immunodeficiency or current autoimmune disease. 11.Have signs or symptoms that could confound or confuse assessment of study vaccine reactogenicity

Design outcomes

Primary

Measure	Time frame
To determine the long term persistence of immune response of Typbar TCVTimepoint: day -60 to -1 day 0 day 28	—

Secondary

Measure	Time frame
â?¢Proportion of participants with local and systemic adverse events â?¢Proportion of participants with Serious Adverse Events Timepoint: Day 28	—

Countries

India

Contacts

Public ContactDr Rajeshri

Bharat Biotech International Limited

rajeshri3822@bharatbiotech.com04023480422

Outcome results