RV vaccine coverage rates and timeliness among qualifying high-risk infants RV related hospitalizations among high-risk infants. (severe) RV gastroenteritis among high-risk infants up to 18 months of age.
Conditions
Interventions
No randomized interventions. This is a step-wedged implementation project of a rotavirus vaccination program for high-risk infants in participating hospitals combined with and observational before-aft
Sponsors
UMC Utrecht
Heidelberglaan 100
3508 GA Utrecht
The Netherlands
Eligibility
Inclusion criteria
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: • Gestational age less than 36 weeks and 0 days • Birth weight less than 2500 grams • A qualifying diagnoses of severe congenital malformation or perinatal morbidity
Exclusion criteria
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). • A diagnosis of severe (congenital) immunodeficiency syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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. • 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. • Proportion of eligible high-risk children receiving a full 2-dose course of RV vaccination after implementation of RV vaccination program. | — |
Secondary
| Measure | Time frame |
|---|---|
| Program evaluation • Vaccine coverage among eligible high-risk infants at 6 and 12 months post-implementation and number and causes for missed or delayed RV vaccine doses. • Number and characteristics of serious vaccine adverse events in the 30 days following administration of each dose of oral RV vaccine among high-risk infants. Occurrence is expressed as the number of events per 100 vaccine doses administered. • Proportion of eligible high-risk children receiving at least 1-dose of RV vaccination after implementation of RV vaccination. • Satisfaction and experience among involved physicians and parents with the RV vaccination program concerning organization, information, vaccine deliverance and administration. • Cost-effectiveness of the RV vaccination program and net costs or savings from the healthcare payer perspective. Effectiveness • Vaccine effectiveness in reducing hospitalizations due to RV gastroenteritis and symptomatic nosocomial RV infections among high-risk infants up to 18 months of age. Occurrence is expressed as cumulative number of children with at least one event per number of children at risk. • Vaccine effectiveness in reducing episodes of RV gastroenteritis of any severity between 2 and 18 months of age among high-risk infants. Occurrence is expressed as number of events per 1000 person-years. • RV disease symptoms, severity, related quality of life lost and disruption of family life among high-risk infants and their parents between 2 and 18 months of age. • Anti-rotavirus IgA antibody seroconversion rates at 30-90 days after the complete vaccination series and geometric mean concentrations (GMCs) in vaccinated high-risk infants and at similar time-points in unvaccinated high-risk infants and persistence of anti-rotavirus IgA antibodies at 12-18 months of age. • Effectiveness in reducing nosocomial RV infections in the first and second year after implementation of RV vaccination in participating hospitals. Occurrence is expressed a | — |
Contacts
Public ContactLydeke Zwart
Research Support Unit Julius Centrum - UMC Utrecht
Outcome results
None listed