A STUDY TO EVALUATE THE IMMUNOGENICITY AND SAFETY OF BBIL?s TYPHOID Vi CAPSULAR POLYSACCHARIDE-TETANUS TOXOID PROTEIN CONJUGATE VACCINE VS REFERENCE VACCINE IN HEALTHY SUBJECTS.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/08/001957

Enrollment

981

Registered

2011-08-19

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: 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 vaccination Timepoint: 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 vaccination	—

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 vaccination Timepoint: 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 vaccination

—

Secondary

Measure	Time frame
1. Comparative assessment of safety and tolerability of the vaccine in all subjects up to 3 months post vaccination. 2. Based on the Geometric Mean Titers of the primary objectives 1& 2 the superiority of test over reference vaccine will be determined Timepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Anit Singh

Bharat Biotech International Ltd

anits@bharatbiotech.com04023480567

Outcome results