Rotavirus vaccinatie voor zuigelingen met een medisch risico

Recruiting

• Conditions: RV vaccine coverage rates and timeliness among qualifying high-risk infantsRV related hospitalizations among high-risk infants. (severe) RV gastroenteritis among high-risk infants up to 18 months of age.

• Registration Number: NL-OMON21569
• Lead Sponsor: MC UtrechtHeidelberglaan 1003508 GA UtrechtThe Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 2000

Inclusion Criteria

1. Infants 6 weeks 0 days to 13 weeks 6 days of age who receive medical care in hospital or through outpatient clinics at the time of the first vaccine dose administration in one of the participating hospitals and

2. Diagnosed with at least one high-risk condition:

Exclusion Criteria

• Known hypersensitivity to any of the vaccine components.

• Previous intussusception or an uncorrected congenital condition predisposing to intussusception (such as Meckel’s diverticle).

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• The impact of the RV vaccination program on number of hospitalizations due to RV gastroenteritis and symptomatic nosocomial RV infections among high-risk infants in the first and second year after implementation. Occurrence is expressed as cumulative number of children with at least one hospitalization due to RV gastroenteritis or symptomatic nosocomial RV infection in one of the participating hospitals per number of children at risk.<br /><br>• Vaccine effectiveness in reducing episodes of severe RV gastroenteritis between 2 and 18 months of age among high-risk infants included in the follow-up study. Occurrence is expressed as number of events per 1000 person-years.<br /><br>• Proportion of eligible high-risk children receiving a full 2-dose course of RV vaccination after implementation of RV vaccination program.