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Covaxin Vaccination Effectiveness in Children and Adolescents in India

Effectiveness of Covaxin Vaccination in Preventing Covid-19-Associated Emergency, Urgent Care Encounters and Hospitalizations Among Children and Adolescents in India, An Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/09/045840
Enrollment
98000
Registered
2022-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

None listed

Interventions

None listed

Sponsors

Bharat Biotech International Limited BBIL
Lead Sponsor
Clinical Research Network India CRO
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Families which have children in the age group 6 to 18 years. Intention of being available for entire study period

Exclusion criteria

Exclusion criteria: Children with any 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. Unable to comprehend the questions Unable to provide written informed consent

Design outcomes

Primary

MeasureTime frame
Number and frequency (infection rate) of symptomatic COVID-19 infection in children from fully vaccinated, partially vaccinated, and unvaccinated cohort from both rural and urban areas (separately and combined). Severity of COVID-19 infection in children from fully vaccinated, partially vaccinated, and unvaccinated cohort observed from both rural and urban areas (separately and combined). Timepoint: The subject and their families will be followed up for every 30 days for a period of one year as per the pre-decided schedule.

Secondary

MeasureTime frame
Number and frequency (infection rate) of reinfection in children from fully vaccinated, partially vaccinated, and unvaccinated cohort from both rural and urban areas (separately and combined). Correlation/association of COVID-19 with select socio-demographic groups.Timepoint: The subject and their families will be followed up for every 30 days for a period of one year as per the pre-decided schedule.

Countries

India

Contacts

Public ContactDr Nidhi Singh

Bharat Biotech International Ltd

kmohan@bharatbiotech.com914023480567

Outcome results

None listed

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