A Surveillance Study on Timing and Coverage Of Rotavirus and MenB Vaccine Co-administration in Campania Region, Italy
NCT ID: NCT05212935
Last Updated: 2022-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2022-05-31
2023-04-30
Brief Summary
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1. st phase (2018-2020)
* To investigate the vaccination coverage for Rotavirus vaccine (RV) in Campania Region together with other pediatric vaccinations scheduled in the first 12 months of life: hexavalent, pneumococcal conjugate (PCV), meningococcal B (MenB)
* To collect data on appropriate timing of the 3 doses of human bovine pentavalent reassortant vaccine (RV5) administration
* To evaluate the frequency of a co-administration of RV5 with other vaccines scheduled in the first 12 months of life (hexavalent/PCV+RV5, MenB+RV5 vs RV5 alone) and assess the variability in co-administration rates according to RV5 dose
2. nd phase (2020-2022)
* To investigate the effect of Coronavirus-Disease-19 (COVID-19) pandemic on vaccination coverage in the first year of life, focusing on RV vaccination
* To investigate the effect of COVID-19 pandemic on timing of vaccine administration in the first year of life, focusing on those vaccines without catch-up vaccination schedule (i.e. RV)
Hypothesis are the following:
* Vaccination coverage and timing of vaccines scheduled in the first year of life are not fully aligned with what is established by the Italian National Prevention Plan 2017-2019
* Co-administration of RV5 and MenB in comparison with other coadministration e.g. hexavalent/PCV is lower
* Co-administration of RV5 and MenB allows to ensure appropriate timing of RV vaccination schedule
* COVID-19 pandemic may have affected the overall vaccination coverage as well as the timing of selected vaccination scheduled in the first year of life, with a more relevant impact on vaccines for whom a catch-up vaccination schedule is not feasible, such as RV immunization.
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Detailed Description
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* To investigate the vaccination coverage for Rotavirus vaccine (RV) in Campania Region together with other pediatric vaccinations scheduled in the first 12 months of life: hexavalent, pneumococcal conjugate (PCV), meningococcal B (MenB)
* To collect data on appropriate timing of the 3 doses of human bovine pentavalent reassortant vaccine (RV5), which is the most used RV vaccine in Campania Region.
* To evaluate the frequency of a co-administration of RV5 with other vaccines scheduled in the first 12 months of life (hexavalent/PCV+RV5, MenB+RV5 vs RV5 alone) and assess the variability in co-administration rates according to RV5 dose
* To investigate the effect of Coronavirus-Disease-19 (COVID-19) pandemic on vaccination coverage and on timing of vaccine administration in the first year of life, focusing on RV vaccination
The study consists of two parallel phases:
1. First phase aimed at enrolling children who received a vaccine in first 12 months of life between January 2018 and December 2020. These data would provide informative data about the pre-pandemic situation and the impact of restrictive measures against COVID-19 on vaccination.
2. Second phase, enrolling children aged between 6 weeks to 12 months who will enter the national Immunization schedule according to the Italian Immunization Plan up to June 2022 (cohort 2021), in order to investigate a possible role of COVID-19 pandemic and new strategies applied at local level for a catch-up vaccination in the first year of life.
A specific digital dataset will be created to collect data about the number of eligible children who received vaccinations in the territory of each Vaccination Center during the study period. The rough data will be extrapolated by an investigator for each Vaccination province through a single chart reviewing from the regional vaccination database. The regional electronic immunization register is currently used for the entire immunization process (from vaccination call-out, to calculating the vaccination coverage, up to send aggregated data to the Ministry of Health in order to estimate the national vaccination coverage).
The characteristics of each vaccine administered will be recorded (i.e. brand, number of doses) as well as the lass of time between vaccination and possible delay.
Anonymized data obtained by the Regional Registry will be used to analyze vaccination coverage according to age and cohort, timing of administration and frequency and type of co-administration.
Hypothesis are the following:
* Vaccination coverage and timing of vaccines scheduled in the first year of life are not fully aligned with what is established by the Italian National Prevention Plan 2017-2019
* Co-administration of RV5 and MenB in comparison with other coadministration e.g. hexavalent/PCV is lower
* Co-administration of RV5 and MenB allows to ensure appropriate timing of RV vaccination schedule
* COVID-19 pandemic may have affected the overall vaccination coverage as well as the timing of selected vaccination scheduled in the first year of life, with a more relevant impact on vaccines for whom a catch-up vaccination schedule is not feasible, such as RV immunization.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
RETROSPECTIVE
Study Groups
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Children below 12 months of age receiving vaccines according to the National Vaccination Plan
All children who received vaccination in their first 12 months of life between January 2018 and June 2022 in the Regional Vaccination Centers involved in the study.
Children will be classified in sub-groups, according to different vaccination schedules (single or co-administration) and order of vaccine uptake.
Rotavirus Vaccine
administration of the 3 doses of Rotavirus human bovine pentavalent reassortant vaccine
Interventions
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Rotavirus Vaccine
administration of the 3 doses of Rotavirus human bovine pentavalent reassortant vaccine
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Weeks
12 Months
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Federico II University
OTHER
Responsible Party
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Andrea Lo Vecchio, MD, PhD
Assistant Professor
Principal Investigators
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Andrea Lo Vecchio, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federico II University
Central Contacts
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References
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Poelaert D, Pereira P, Gardner R, Standaert B, Benninghoff B. A review of recommendations for rotavirus vaccination in Europe: Arguments for change. Vaccine. 2018 Apr 19;36(17):2243-2253. doi: 10.1016/j.vaccine.2018.02.080. Epub 2018 Mar 22.
Lo Vecchio A, Liguoro I, Dias JA, Berkley JA, Boey C, Cohen MB, Cruchet S, Salazar-Lindo E, Podder S, Sandhu B, Sherman PM, Shimizu T, Guarino A. Rotavirus immunization: Global coverage and local barriers for implementation. Vaccine. 2017 Mar 14;35(12):1637-1644. doi: 10.1016/j.vaccine.2017.01.082. Epub 2017 Feb 16.
Foster S. Rotavirus vaccine and intussusception. J Pediatr Pharmacol Ther. 2007 Jan;12(1):4-7. doi: 10.5863/1551-6776-12.1.4. No abstract available.
O'Ryan M, Stoddard J, Toneatto D, Wassil J, Dull PM. A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program. Drugs. 2014 Jan;74(1):15-30. doi: 10.1007/s40265-013-0155-7.
DeSilva MB, Haapala J, Vazquez-Benitez G, Daley MF, Nordin JD, Klein NP, Henninger ML, Williams JTB, Hambidge SJ, Jackson ML, Donahue JG, Qian L, Lindley MC, Gee J, Weintraub ES, Kharbanda EO. Association of the COVID-19 Pandemic With Routine Childhood Vaccination Rates and Proportion Up to Date With Vaccinations Across 8 US Health Systems in the Vaccine Safety Datalink. JAMA Pediatr. 2022 Jan 1;176(1):68-77. doi: 10.1001/jamapediatrics.2021.4251.
Other Identifiers
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432/21
Identifier Type: -
Identifier Source: org_study_id
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