None listed
Conditions
Interventions
None listed
Sponsors
Invotree Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of 2-18 yearsâ?? age, healthy or with co-morbidities or recovered from covid infection and who have completed at least one dose of vaccination from available vaccines in India and complete final dose of vaccination by September 2022. 2. Study subjects willing to sign data sharing consent. 3. Study subjects 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
| Measure | Time frame |
|---|---|
| Number of Adverse events / TEAEs (Treatment emergent adverse events) post vaccinationTimepoint: Every Month from Previous dose of vaccine untill 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Percentage of study subjects contracting COVID-19 infection post vaccination confirmed by RT-PCR testTimepoint: Every Month from Previous dose of vaccine untill 12 months;Time taken (in days) by subjects contracting COVID-19 infection post vaccination confirmed by RT-PCR test.Timepoint: Every Month from Previous dose of vaccine untill 12 months;Percentage of study subjects contracting COVID-19 infection post previous dose of vaccine, classified as being asymptomatic, mild, moderate and severeTimepoint: 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;Percentage of study subjects having overall Quality of Life score assessed by Health Survey questionnaire as satisfactoryTimepoint: Every Month from Previous dose of vaccine untill 12 months | — |
Countries
India
Contacts
Public ContactDr Kavita Pingale
Innvocept Global Solutions Pvt Limited
Outcome results
None listed