A Study to Evaluate the Immunogenicity and Safety Of Booster Dose Effect BBIL Typhoid conjugate vaccine

A PHASE III, RANDOMIZED, MULTICENTERIC, CONTROLLED STUDY TO EVALUATE THE IMMUNOGENICITY AND SAFETY OF BBILs TYPHOID Vi CAPSULAR POLYSACCHARIDE-TETANUS TOXOID PROTEIN CONJUGATE VACCINE VS REFERENCE VACCINE IN HEALTHY SUBJECTS. - Typbar TCV

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2014/01/004341

Enrollment

981

Registered

2014-01-23

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: TYPHOID TT Vaccine: Typhoid Vi capsular polysaccharide-TT protein conjugate vaccine manufactured by Bharat Biotech international Limited, Hyderabad. Administered as one dose of 0.5 ml i

Eligibility

Inclusion criteria

Inclusion criteria: 1.Provide voluntary written and signed informed consent from volunteer or if minor from parent/legal guardian. 2.Healthy subjects in two cohorts aged 6 to 24 months, and 2 - 45 years. 3.Are not participating in or plan to participate in another research during the next three months & be available throughout study period. 4.Family does not plan to move during the study period, and housed not further that 50 Km away from the study site

Exclusion criteria

Exclusion criteria: 1)Fever of any origin or infections more than 3 days within one month prior to screening or on the day of screening 2)Any confirmed or suspected immunosuppressive condition. 3)Any treatment with immunosuppressive or immunostimulant therapy 4)Use of any marketed or investigational or herbal medicine or non-registered drug or vaccine for typhoid. 5)Life threatening or serious cardiac (NYHA grade 3&4), respiratory, gastrointestinal, hepatic, renal, endocrine and systemic disorders. 6)Have been vaccinated against typhoid fever or had exposure to typhoid fever within the last three years.

Design outcomes

Primary

Measure	Time frame
The comparative assessment of the immunogenicity of the test vaccine (conjugate typhoid vaccine) versus the comparator (polysaccharide typhoid vaccine) by estimation of: 1. 4 fold Seroconversion rates in each treatment arm at 6 weeks post vaccination. 2. 4 fold Seroconversion rate in Cohort-1(2 years) from base line to 6 weeks post vaccination. 3. Extent of rise of anti Vi IgG antibody from baseline values to 6 weeks post vaccinationTimepoint: samples will be 24 months and a booster dose will be administered and samples will be collected at 42 day and 36 months and the data will be anaklysed for the same	—

Measure

Time frame

The comparative assessment of the immunogenicity of the test vaccine (conjugate typhoid vaccine) versus the comparator (polysaccharide typhoid vaccine) by estimation of: 1. 4 fold Seroconversion rates in each treatment arm at 6 weeks post vaccination. 2. 4 fold Seroconversion rate in Cohort-1(2 years) from base line to 6 weeks post vaccination. 3. Extent of rise of anti Vi IgG antibody from baseline values to 6 weeks post vaccinationTimepoint: samples will be 24 months and a booster dose will be administered and samples will be collected at 42 day and 36 months and the data will be anaklysed for the same

—

Secondary

Measure	Time frame
1.To evaluate the immunogenicity on Day 0, Day 42Â±2 12 Months, 24 Months and 36 months for antibody titers estimation. 2.To evaluate the immunogenicity on Day 42Â±2 (from the day of booster dose vaccination) and 36 months for antibody titers estimation in booster dose received subset and comparison with subset without booster dose received at 36 months. Timepoint: 3 years	—

Countries

India

Contacts

Public ContactDrBN Patnaik

Bharat Biotech International Ltd

badri2299@bharatbiotech.com04023480567

Outcome results