| Trial registration number
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CTRI/2020/08/027170 |
Full text link
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46186
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First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Dr Prasad Kulkarni
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Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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drpsk@seruminstitute.com
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Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2020-08-15
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Recruitment status
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not recruiting
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Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Healthy adults aged more than or equal to 18 years of either sex. <br/ >2. Written informed consent by participants. <br/ >3. The participant is resident of the study area and is willing to comply with study protocol requirements. <br/ >4. Healthy, as determined by medical history and physical examination. <br/ >5. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.
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Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Acute illness with or without fever at the time of study vaccine administration <br/ >2. History of laboratory confirmed COVID-19 disease in household contact or close workplace contact <br/ >3. IgG seropositivity to SARS-CoV-2 <br/ >4. History or currently positive for SARS-CoV-2 by RT-PCR <br/ >5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines <br/ >6. Any confirmed or suspected condition with impaired/altered function of immune system
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Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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3
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Funding
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Serum Institute of India Private Limited
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Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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99
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Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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India
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Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Healthy volunteers
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Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1600
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primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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1. Occurrence of causally related SAEs throughout the study duration following vaccination <br/ >2. Ratio of GMTs <br/ >of anti-S IgG antibodiesTimepoint: 1. Throughout the study duration following vaccination <br/ >2. 28 days after the second <br/ >vaccination
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Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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| Declared number of arm (3.0)
differs from found arms (4.0)
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Phase
Last imported at : Oct. 26, 2020, 8:29 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 2/Phase 3
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Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "0,5ml;2;day1-29 (Covishield SII-ChAdOx1 nCoV-19)", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0,5ml;2;day1-29 (Oxford/AZ-ChAdOx1 nCoV-19)", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]
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