None listed
Conditions
Interventions
None listed
Sponsors
Bharat Biotech International Limited
Clinical Research Network India CRO
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 years and older who have received at least 2 primary doses of COVAXIN�® 9 months prior to enrolment or third dose (booster or precautionary dose) of COVAXIN�® within 6month prior to enrolment. The subject should have received third dose at least 14 days before he/she is enrolled in the study. Individuals with stable pre-existing medical conditions such as hypertension, diabetes, obesity, cardiovascular disease, respiratory disorders, liver disease or any other stable chronic disorders). Intention of being available for entire study period
Exclusion criteria
Exclusion criteria: Population aged below 18 years Subjects with chronic illness, disorder, or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint. Subjects with psychiatric disorders Subject who has taken COVID vaccine other than COVAXIN�® Subject who has received single dose of COVAXIN�® Subjects who cannot provide written consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of booster dose of the COVAXINÃ?® vaccine against COVID-19-related symptoms, hospitalization and death will be determined by estimating: Number and frequency of symptomatic COVID-19 incidence in participants who have received 3 doses as compared to 2 primary doses of COVAXINÃ?®. COVID-19 related outcome in participants who have received 3 doses (2 primary doses and booster dose) as compared to 2 primary doses of COVAXINÃ?®. Timepoint: The subject will be followed up for every 30 days for the study duration as per the pre-decided schedule | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and frequency (incidence rate) of symptomatic COVID-19 infection in different age groups Number and frequency (incidence rate) of symptomatic COVID-19 infection with respect to stable pre-existing comorbidities such as hypertension, diabetes, obesity, cardiovascular disease, respiratory disorders, liver disease or any other stable chronic disorders). Number and frequency (infection rate) of symptomatic COVID-19 reinfection Timepoint: The subject will be followed up for every 30 days for the study duration as per the pre-decided schedule. | — |
Countries
India
Contacts
Public ContactDr Nidhi Singh
Bharat Biotech International Ltd
Outcome results
None listed