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

March 15, 2022 updated by: Andrea Lo Vecchio, MD, PhD, Federico II University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be carried out in collaboration with eight Vaccination Centers, which are responsible in Italy for the organization and delivery of vaccination as well as for overseeing implementation of vaccinations and monitoring coverage, in four provinces of Campania Region (representative of different regional areas) with the following aims:

  • 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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children receiving vaccination in their first year of life at one of the Vaccination Centers involved in the study

Description

Inclusion Criteria:

  • all children receiving vaccination according to the Italian National Vaccine Prevention Plan 2017-2019

Exclusion Criteria:

  • primary outcomes data missing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: Rotavirus Vaccine
administration of the 3 doses of Rotavirus human bovine pentavalent reassortant vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall proportion of children fully immunized for RV and proportion of immunized children in each subgroup
Time Frame: 32 weeks
32 weeks
Proportion of children receiving the first RV5 dose within 12 weeks of age
Time Frame: 32 weeks
32 weeks
Proportion of children completing RV5 schedule within 32 weeks of age
Time Frame: 32 weeks
32 weeks
Proportion of children receiving the co-administration RV5 + MenB
Time Frame: 32 weeks
32 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of children partially immunized (1 or 2 doses) or not immunized for RV in each subgroup
Time Frame: 32 weeks
32 weeks
Proportion of children receiving RV5 immunization doses alone
Time Frame: 32 weeks
32 weeks
Proportion of children receiving the co-administration of RV5+hexavalent/PCV
Time Frame: 32 weeks
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Andrea Lo Vecchio, MD, PhD, Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

January 16, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 432/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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