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Study to assess the safety profile of COVID 19 vaccines in India

Sentinel Surveillance for Adverse Events of Special Interest (AESI) following COVID-19 vaccination in India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/11/038321
Enrollment
230
Registered
2021-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: G040- Acute disseminated encephalitis and encephalomyelitis (ADEM) Health Condition 2: I21- Acute myocardial infarction Health Condition 3: I40- Acute myocarditis Health Condition 4: I30- Acute pericarditis Health Condition 5: J80- Acute respiratory distress syndrome Health Condition 6: I63- Cerebral infarction Health Condition 7: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 8: G049- Encephalitis, myelitis and encephalomyelitis, unsp

Interventions

None listed

Sponsors

John Snow India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Admitted for at least 24 hours Diagnosis that meets any of the 11 index clinical conditions (AESIs)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Assessment of the excess risk for the targeted eleven AESIs following COVID-19 vaccination using Self Controlled Case Series method and finding Incidence Rate Ratio.Timepoint: Depending upon the AESI conditions the observation period will vary from 28 days - 168 days—

Secondary

MeasureTime frame
Establishment of multi-centric AEFI/AESI sentinel surveillance network across IndiaTimepoint: 18 months—

Countries

India

Contacts

Public ContactDr Deepak Polpakara

Immunization Technical Support Unit (ITSU), JSI

deepak_polpakara@in.jsi.com9868878721

Outcome results

None listed

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