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Trial - CTRI/2022/06/043447


Column Value
Trial registration number CTRI/2022/06/043447
Full text link
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Dr Madhu Gupta

Contact
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

madhugupta21@gmail.com

Registration date
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2022-06-23

Recruitment status
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Prevention

Inclusion criteria
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

healthy

Exclusion criteria
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

children less than 18 years

Number of arms
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

6

Funding
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Indian Council of Medical Research

Inclusion age min
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

80

Countries
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

India

Type of patients
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Healthy volunteers

Severity scale
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

N/A

Total sample size
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1542

primary outcome
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1. Antibody titers against Spike protein after interchangeability of the study vaccines at baseline; 28 days of first and second dose; 6 months and 1 year. <br/ >2. Incidence of mild; moderate and serious adverse events rate of the Covid-19 vaccines after interchangeability <br/ >3. Breakthrough infection rate of the Covid-19 vaccines (Covishield/Covaxin/Sputnik V) after interchangeability.Timepoint: At at baseline; 28 days of first and second dose; 6 months and 1 year.

Notes
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (5.0) differs from found arms (6.0)

Phase
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 4

Arms
Last imported at : June 30, 2022, 4:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 1522, "treatment_name": "Chadox1 ncov-19+gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2546, "treatment_name": "Covaxin+gam-covid-vac", "treatment_type": "Inactivated virus+non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "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": 532, "treatment_name": "Gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1898, "treatment_name": "Chadox1 ncov-19+covaxin", "treatment_type": "Non replicating viral vector+inactivated virus", "pharmacological_treatment": "Vaccine"}]