Trial to evaluate 3mg dose of Covid Vaccine of Cadila healthcare Limited

Phase 3

Completed

• Registration Number: CTRI/2021/10/037137
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-06-11
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3000

Inclusion Criteria

1. Healthy subject of either gender >=12 years of age

2. Informed consent from the subjects / LAR and assent from subjects >=12 to <18 years of age

3. Adult subjects / LAR literate enough to fill the diary card

4. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization), from screening until completion of the followup visit and males who agree to use contraception

Exclusion Criteria

1. Febrile illness (temperature >= 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment

2. History or laboratory evidence of confirmed SARS-CoV-2 positive in last 3 months

3. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days

4. Subjects positive for antibodies against SARS-CoV-2 on antibody detection test (for immunogenicity cohort only) / RTPCR positive at the time of screening

5. History of SARS/ MERS infection

6. Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine

7. Past history of hypersensitivity reaction or any serious adverse event after any vaccination

8. Subjects with known history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy

9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy

10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder

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

12. Any other vaccine administration within the last 30 days or planned to be administered during the study period

13. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)

14. Participation in another clinical trial in the past 3 months

15. History of drug / alcohol abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-inferiority based on seroconversion rate based on IgG antibodies against S1 <br/ ><br>antigen (by ELISA) and NAB at Day 56 of 3mg â?? 2 dose regimen against the Day 84 <br/ ><br>data from the ongoing Phase III clinical trial with 2mg â?? 3 dose regimen <br/ ><br> <br/ ><br>Adverse events (solicited, unsolicited and SAEs) reported during the studyTimepoint: Day 56

Secondary Outcome Measures

Name	Time	Method
GMTs and GMFR based on IgG antibodies against S1 antigen (by ELISA)Timepoint: Day 56 and 196;Seroconversion rate based on of IgG antibodies against S1 antigen (by ELISA)Timepoint: Day 196;Seroconversion rate, GMTs and GMFR based on Neutralizing antibody assayTimepoint: Day 196