Status: Finalised
First registered on:
29/07/2019
Last updated on:
29/07/2019
1. Study identification
EU PAS Register NumberEUPAS30702
Official titleSpatio-temporal impact of Rotavirus vaccine coverage on Rotavirus Hospitalizations in the Valencia Region, Spain (AIV - FISABIO)
Study title acronym
Study typeObservational study
Brief description of the study
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameFISABIO - Public Health
Centre locationAv. Cataluña, 21 46020 Valencia, Spain
Details of (Primary) lead investigator
Title Dr
Last name Díez-Domingo
First name Javier
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed25/10/201725/10/2017
Start date of data collection13/12/201713/12/2017
Start date of data analysis02/01/201802/01/2018
Date of interim report, if expected30/08/201830/08/2018
Date of final study report30/09/201830/09/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMSD100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mrs
Last name López-Lacort
First name Mónica
Address line 1Av. Cataluña 21
Address line 2
Address line 3
CityValencia
Postcode46020
CountrySpain
Phone number (incl. country code)961926312
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Díez-Domingo
First name Javier
Address line 1Av. Cataluña, 21 46020
Address line 2
Address line 3
CityValencia
Postcode46020
CountrySpain
Phone number (incl. country code)961925937
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Rotavirus infection
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects721741
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
Exposure registry
11. Scope of the study
What is the scope of the study?
Effectiveness evaluation
Post-licensure vaccine impact study
Primary scope : Post-licensure vaccine impact study
12. Main objective(s)
What is the main objective of the study?
- To estimate spatio-temporal impact of rotavirus vaccine coverage on rotavirus acute gastroenteritis hospitalizations among Valencia Region´s population aged less than 3 years.
- To assess space-time variation in hospitalized acute rotavirus gastroenteritis risk.
- To assess space-time variation in rotavirus vaccine coverage.
Are there primary outcomes?Yes
- Rotavirus acute gastroenteritis hospitalization: hospitalization with a discharge diagnosis of enteritis due to rotavirus (ICD-9-CM code 008.61) in any diagnosis position.
Are there secondary outcomes?Yes
- Acute gastroenteritis hospitalization: hospitalization with a discharge diagnosis of gastroenteritis-associated episode (ICD-9-CM codes 001-009, 558.9, 787.91) in any diagnosis position.
13. Study design
What is the design of the study?
retrospective, population-based study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
We evaluate the spatio-temporal impact of vaccination on rotavirus hospitalization rates (response variable) by a Bayesian spatio-temporal logistic regression contemplating gender, age, health department, bi-annual periods and health care district.
To evaluate the space-time behavior of rotavirus/ hospitalization rates and vaccine coverage, we model by the Besag-York-Mollié model the following smoothed risk estimates: the standardized hospitalization ratio and the standardized vaccination rate, considering bi-annual periods and health care districts.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
