A Phase III Study to Evaluate the Immunogenicity and Safety of Typbar TCV Typhoid Vaccine in Adults greater than 65 Years.

Phase 3

• Registration Number: CTRI/2024/06/069638
• Lead Sponsor: Bharat Biotech International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Subjects of age =18 without significant medical history or abnormal

clinical findings

2. Subject who has been explained about all risks and benefits of the

Trail and is willing to provide written informed consent.

3. Agrees to be available for all Trail related visits and procedures

throughout the duration of the Trail.

4. Female subjects of child bearing potential must demonstrate a negative

urine pregnancy test at the time of screening.

5. Individuals who are in good health as determined by the outcome of

medical history, physical examination and based on clinical judgement of

the Principal Investigator.

Exclusion Criteria

1. Subjects who are under the age of 18 years

2. Fever of any origin or duration for more than 3 days prior to intended Trail immunization

3. History of Typhoid vaccination in the last 5 years

4. History of Typhoid disease in the last 5 years

5. History of any illness or any laboratory abnormality that, in the opinion of the investigator, might

interfere with the results of the Trail or pose additional risk to the subjects due to participation

in the Trail

6. Individuals with any serious chronic or progressive diseases according to the judgment of

Investigator (eg: neurological, neoplasm, insulin dependent diabetes, hepatic, renal, cardiac

diseases).

7. Any confirmed or suspected use of immunosuppressive drugs or immunodeficient condition.

8. Use of any marketed/investigational/herbal medicine or non-registered drug or vaccine for Typhoid.

9. Any criteria, which in the opinion of the investigator, suggests that the subject may not be

compliant with the Trail protocol.

10. History of allergy or allergic reactions to vaccine or any vaccine component

11. Women who are pregnant or breast-feeding.

12. Married or sexually active participants who are not willing to follow effective birth control

methods for at least 3 months after vaccine.

13. Individuals participating in any other clinical trial within one month prior to Trail participation

or intent to participate in any other clinical trial during the conduct of the Trail

Study & Design

• Study Type: Interventional
• Study Design: Not specified