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A Surveillance Study on Timing and Coverage Of Rotavirus and MenB Vaccine Co-administration in Campania Region, Italy

NCT05212935 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2022-03-17

No results posted yet for this study

Summary

A two-phases study will be carried out with the following aims

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.

Conditions

  • Vaccination
  • Rotavirus Infections
  • Meningococcal Infections

Interventions

BIOLOGICAL

Rotavirus Vaccine

administration of the 3 doses of Rotavirus human bovine pentavalent reassortant vaccine

Sponsors & Collaborators

Principal Investigators

  • Andrea Lo Vecchio, MD, PhD · Federico II University

Eligibility

Min Age
6 Weeks
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2022-10-31
Completion
2023-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05212935 on ClinicalTrials.gov