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A study to estimate burden of rotavirus diarrhea in children under the age of 24 months

A Multicenter prospective community based surveillance to estimate the burden of rotavirus gastroenteritis in children â?¤ 24 months of age in India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2015/10/006287
Enrollment
3000
Registered
2015-10-21
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

Health Condition 1: null- Incidence of severe Rotavirus Gastroenteritis

Interventions

None listed

Sponsors

Shantha Biotechnics PvtLtd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •Children •Parents/Legally Acceptable Representative willing to sign ICF for inclusion in the study.

Exclusion criteria

Exclusion criteria: •Non-resident or not belonging to the predefined population study base •Subject reporting to hospital with an episode of diarrhea with onset more than 14 days

Design outcomes

Primary

MeasureTime frame
â?¢To estimate the incidence of severe rotavirus gastroenteritis (SRVGE) in children below 24 Months â?¢To describe the age, regional and seasonal distribution of SRVGE â?¢To identify the prevalent circulating strains of rotavirus in the population under surveillance Timepoint: NA

Secondary

MeasureTime frame
â?¢To estimate the incidence of very severe rotavirus gastroenteritis (VSRVGE) in children below 24 Months. â?¢To estimate the incidence of rotavirus gastroenteritis of any severity associated with rotavirus in hospitalized children below 24 Months. â?¢To estimate the incidence of hospitalization due to all causes of gastroenteritis in children below 24 Months Timepoint: NA

Countries

India

Contacts

Public ContactDrBadri Narayan Patnaik

Shantha Biotechnics Private Limited

Tarun.Saluja@sanofi.com04066301507

Outcome results

None listed

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