To study the effectiveness and safety of Rotasiil vaccine in Jharkhand

Not Applicable

Conditions: Health Condition 1: K561- IntussusceptionHealth Condition 2: A080- Rotaviral enteritis

Registration Number: CTRI/2019/02/017825

Lead Sponsor: PATH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 1422

Inclusion Criteria

I.Rotavirus Gastroenteritis Surveillance

1.Parent/LAR has provided written informed consent.

2.Present to one of the surveillance sites for treatment of AGE.

3.Are <5 years of age.

4.Produce a stool sample during the first 48 hours after presentation and are either treated with oral or intravenous fluids at the Emergency Department and discharged home or admitted to the hospital and treated with oral rehydration or intravenous fluids.

II.Vaccine Effectiveness Case-Control Evaluation

1.Meet the inclusion criteria and case definition for the RVGE surveillance program plus the eligible to have received at least one dose of vaccine prior to illness, i.e. age 8 weeks or older and born after February 24, 2018 (i.e., 6 weeks prior to the initial launch of Rotasiil® in Jharkhand).

2.Are <2 years of age

3.Residence in the state of Jharkhand.

III.Intussusception Surveillance:

1.Parent/LAR has provided written informed consent.

2.Are <2 years of age

3.Born after February 24, 2018

4.Meet the case definition for intussusception using the Level 1 Brighton criteria.

IV.Cost of illness study:

1.Enrolled into either the rotavirus gastroenteritis surveillance or intussusception surveillance programs, as applicable (are <5 years of age for rotavirus AGE surveillance and < 2 years of age for IS surveillance)

2.Parent willing to provide information to fill the questionnaire.

Exclusion Criteria

I.Rotavirus Gastroenteritis Surveillance

1.Are 5 or more years of age

2. Unable to contact parent/LAR to obtain written informed consent.

3.Admitted to another hospital for >24 hours (and subsequently transferred to the current hospital).

II.Vaccine Effectiveness Case-Control Evaluation

1.Are age-ineligible to have received vaccine.

2.Illness onset is less than 2 weeks following initial vaccination

3.Vaccination record cannot be obtained either through the vaccination card or other records

4.Are >2 years of age

5.Participants with hospital acquired gastroenteritis

6.Participants in whom rotavirus vaccination is contraindicated

7.Parent/LAR unable to provide written informed consent.

III.Intussusception surveillance

1.Parent or LAR unwilling or unable to provide written informed consent.

2.If vaccination status cannot be confirmed

IV.Cost of illness study

1.Parent or LAR unwilling or unable to provide written informed consent.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Establish a sentinel site-based platform for surveillance of gastroenteritis in children under the age of 5 years in the state of Jharkhand. <br/ ><br>2.Generate data on the effectiveness of Rotasiil vaccine in children hospitalised with severe rotavirus gastroenteritis. <br/ ><br>3.Generate data on risk associated with developing intussusception due to Rotasiil vaccine. <br/ ><br>4.Generate estimates of costs incurred for treatment of acute gastroenteritis and intussusception among under five children.Timepoint: During the period March 2019 and February 2021

Secondary Outcome Measures

Name	Time	Method
1.Generate data on distribution of circulating genotypes of rotavirus among under five children in Jharkhand.Timepoint: Whenever eligible children are hospitalised during the period March 2019 and February 2021