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

Phase 4

Completed

• Registration Number: CTRI/2014/01/004341
• Lead Sponsor: Bharat Biotech International Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 981

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

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.

Study & Design

• Study Type: PMS
• Study Design: Not specified