A clinical study to evaluate non-interference of immune response generated by Typhoid conjugate vaccine and Measles and Rubella vaccine administered to healthy infants

Phase 4

Completed

• Registration Number: CTRI/2022/02/040274
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-22
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 900

Inclusion Criteria

1. Healthy infant subject of either gender aged (Age calculated as per completed months) 9 to 10 months at the time of enrollment

2. Subjects should be in good health as determined by medical history and physical examination based on clinical judgment of the investigator

3. No history of vaccination against typhoid fever, measles and rubella

4. Written informed consent from the subjectâ??s parent (mother/father)

5. Subjectâ??s parent literate enough to fill the diary card

Exclusion Criteria

1. History of hypersensitivity reaction to any component of the vaccines

2. History of laboratory confirmed or suspected measles, rubella or typhoid fever in past

3. History of any vaccination against typhoid fever, measles or rubella in past

4. Subject exposed (Close contact (family member or neighbour) with laboratory confirmed or clinical diagnosis

of measles / rubella / typhoid fever) to measles virus, rubella virus or Salmonella typhi within the past 30 days

5. Fever of any origin or infectious disorder of 3 days or more within the past 30 days

6. Febrile illness (axillary temperature >= 37.5°C) at the time of enrollment

7. History of any vaccination within the past 30 days

8. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder

9. Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy

10. Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy

11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study

12. Subject participated in another clinical study in the past 3 months

13. Any other reason for which the investigator feels that subject should not participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-inferiority for seroconversion for anti-Vi, anti-measles and anti-rubella IgG <br/ ><br>antibodiesTimepoint: At 28 days after respective vaccination

Secondary Outcome Measures

Name	Time	Method
Adverse events reportedTimepoint: Throughout the study duration;Geometric mean titre of anti-Vi, anti-measles and anti-rubella IgG antibodiesTimepoint: At 28 days after respective vaccination;Seroconversion rate and geometric mean titre of anti-Vi, anti-measles and antirubella <br/ ><br>IgG antibodiesTimepoint: At the end of the study