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Retrospective and prospective observational on Indian population recieved Covid 19 vaccination in India

A Retrospective and Prospective Observational, Non-interventional Longitudinal study to Evaluate the Long-term Safety and Effectiveness of all available vaccines which are approved by Indian Regulatory against Covid-19 in India.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/06/034493
Enrollment
30000
Registered
2021-06-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Nil: Nil

Sponsors

Invotree Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy participants or participants with co-morbidities or subjects recovered covid infection and who have completed at least one dose of vaccination from available vaccines in India and complete final dose of vaccination by December 2021. from 2. Study participants willing to sign data sharing consent. 3. Study participants willing to provide data for minimum or at least six months from previous dose of vaccination

Exclusion criteria

Exclusion criteria: 1. Subjects who are not vaccinated. 2. Subjects who are vaccinated but not willing to consent for data sharing

Design outcomes

Primary

MeasureTime frame
1. Number of Adverse events / TEAEs (Treatment emergent adverse events) post vaccination?Timepoint: Every Month from Previous dose of vaccine untill 12 months—

Secondary

MeasureTime frame
2.Percentage of study participants contracting COVID-19 infection post vaccination confirmed by RT-PCR testTimepoint: Every Month from Previous dose of vaccine untill 12 months;3. Time taken (in days) by participants contracting COVID-19 infection post vaccination confirmed by RT-PCR test.?Timepoint: Every Month from Previous dose of vaccine untill 12 months;3.Percentage of study participants contracting COVID-19 infection post previous dose of vaccine, classified as being asymptomatic, mild, moderate and severe.Timepoint: Every Month from Previous dose of vaccine untill 12 months;6. Percentage of study participants having overall Quality of Life score assessed by WHOQOL-BREF as satisfactory.Timepoint: Every Month from Previous dose of vaccine untill 12 months;Total number of days with AEs or TEAEs post previous dose of vaccine.Timepoint: Every Month from Previous dose of vaccine untill 12 months;1. Percentage of study participants who do not contract COVID-19 infection post final dose of vaccine and post first dose of vaccine (whtever applicable) Timepoint: Every Month from Previous dose of vaccine untill 12 months—

Countries

India

Contacts

Public ContactD Kavita Pingale

Innvocept Global Solutions Pvt Limited

kavita.pingale@innvoceptsolutions.com7680074619

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026