COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=67993

Dr Jayashri Krishnan

sonika.newar@jssresearch.com

2022-04-11

Not recruiting

RCT

Randomized

Parallel

Not reported

multi-center

Prevention

Subjects will be enrolled in the study if they meet all the following criteria. <br/ >1. Male and female aged â?¥ 18 years <br/ >2. Subject who had recieved primary vaccination (both doses completed) with either <br/ >a. COVAXIN (Group 1) OR <br/ >b. COVISHIELD (Group 2) <br/ >Where last dose of primary vaccination was taken 6-7 months prior to the screening visit <br/ >3. Subjects who are determined by medical/surgical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study <br/ >4. If the subject had COVID-19 after primary vaccination, that subject should have passed 3 months after being asymptomatic or RT-PCR negative <br/ >5. Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit <br/ >6. Consent for using effective methods of contraception during the entire trial and 3 months after its completion <br/ >7. No evidence of pronounced vaccine-induced reactions or complications after receiving immunobiological products in medical history <br/ >8. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment <br/ >

Subjects will be entered into the study only if they meet none of the following criteria. <br/ >1. Prior receipt of any COVID-19 vaccine in less than 6 months of duration <br/ >2. Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements <br/ >3. Receipt of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days prior to enrollment <br/ >4. Pregnancy or breast-feeding <br/ >5. Tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history <br/ >6. History of severe allergic reaction to drug or vaccine (anaphylactic shock, or other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and randomization day <br/ >7. Chronic immune disease or systemic collagenosis in medical history <br/ >8. Subjects who received transplantation and on immunosuppressive therapy <br/ >9. Other immunosuppressive therapy (other than steroids) that completed less than three months prior to randomization into the study <br/ >10. Splenectomy in the past medical history <br/ >11. Subjects with oncological disease within 5 years prior to inclusion into the study <br/ >12. Neutropenia (absolute number of neutrophils less than <1000/mm2), agranulocytosis, severe anemia (hemoglobin < 8 g/l) <br/ >13. Significant loss of blood, Immunodeficiency in the medical history within 6 months before the enrolment <br/ >14. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C <br/ >15. Acute Kidney injury or dialysis <br/ >16. Anorexia or Malnutrition <br/ >17. Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration <br/ >18. Alcohol or Drug addiction in medical history <br/ >19. Participation in other interventional clinical trial within the previous 90 days prior to enrolment and over duration of the trial <br/ >20. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol

3

Dr Reddys Laboratories Limited

18

100

India

Healthy volunteers

N/A

580

To show the non-inferiority between Sputnik Light Booster vs Covaxin and Covishield as booster in terms of: <br/ >â?¢ Proportion of subjects achieving â?¥2-fold increase in neutralizing antibodies at Day 28 from baselineTimepoint: Day 28 from baseline

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 1231, "treatment_name": "Sputnik light vaccine", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1387, "treatment_name": "Covaxin", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]