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To determine the safety and antibody performance in Indian adults after taking COVID-19 vaccine.

Safety and antibody kinetics of the ChAdOx1 nCoV-19 vaccine in Indian adults. - COVID Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/03/031998
Enrollment
6000
Registered
2021-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: None: Not Applicable Intervention2: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Advanced Cancer for Treatment Research and Education in cancer and Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Adults >= 18 years. 2) TMC staff who received at least one dose of the ChAdOx1 nCoV-19 vaccine at the KEM vaccination centre. 3) All individuals who got vaccinated at ACTREC vaccination centre.

Exclusion criteria

Exclusion criteria: None. Anyone fulfilling the inclusion criteria will be eligible for the study

Design outcomes

Primary

MeasureTime frame
To evaluate safety for the vaccine in participants receiving at least 1 dose of the vaccine.Timepoint: 1) Local reactions for up to 7 days following each dose. 2)Systemic events for up to 7 days following each dose. 3) Adverse events (AEs) from Dose 1 to 1 month after the last dose. 4) Serious AEs (SAEs) from Dose 1 to 6 months after the last dose.—

Secondary

MeasureTime frame
SARS-CoV-2 IgG levels will be measured at prespecified time points.Timepoint: On days 7,14,28,56,90 and 120 the IgG levels will be measured.—

Countries

India

Contacts

Public ContactDr Vikram Gota

Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)

vikramgota@gmail.com02227405493

Outcome results

None listed

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