COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=66249

Mohammad Jabeen Ruksana

aigindia@yahoo.co.in

2022-02-23

Not recruiting

nonRCT

Non-randomized

Single group assignment

Open label

single-center

Prevention

1. Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in good health. Note: Heathy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included. <br/ >2. Subject is willing to provide a written informed consent for voluntary participation in the study. <br/ >3. Subject agrees to refrain from blood donation during the course of the study. <br/ >4. Subject have completed at least 6 months duration after second dose of vaccination

1. Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study. <br/ >2. Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: any bleeding disorder <br/ >3. Subjects requiring chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g., corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g., interferons). <br/ >4. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). <br/ >5. Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ >

1

Asian Healthcare Foundation

18

75

India

Healthy volunteers

N/A

2000

1. Safety assessment by determining number of subjects with unsolicited adverse eventsTimepoint: Baseline; 4; 12; 24; 52 weeks

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 1896, "treatment_name": "Corbevax", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]