NCT05212935

Brief Summary

A two-phases study will be carried out 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) 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
  • 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

December 21, 2021

Last Update Submit

March 15, 2022

Conditions

VaccinationRotavirus InfectionsMeningococcal Infections

Keywords

Vaccination coverageRotavirusMeningococcus

Outcome Measures

Primary Outcomes (4)

  • Overall proportion of children fully immunized for RV and proportion of immunized children in each subgroup

    32 weeks

  • Proportion of children receiving the first RV5 dose within 12 weeks of age

    32 weeks

  • Proportion of children completing RV5 schedule within 32 weeks of age

    32 weeks

  • Proportion of children receiving the co-administration RV5 + MenB

    32 weeks

Secondary Outcomes (3)

  • Proportion of children partially immunized (1 or 2 doses) or not immunized for RV in each subgroup

    32 weeks

  • Proportion of children receiving RV5 immunization doses alone

    32 weeks

  • Proportion of children receiving the co-administration of RV5+hexavalent/PCV

    32 weeks

Study Arms (1)

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

Interventions

Rotavirus VaccineBIOLOGICAL

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

Children below 12 months of age receiving vaccines according to the National Vaccination Plan

Eligibility Criteria

Age6 Weeks - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • primary outcomes data missing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 29576308BACKGROUND

  • 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.

    PMID: 28216189BACKGROUND

  • 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.

    PMID: 23055840BACKGROUND

  • 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.

    PMID: 24338083BACKGROUND

  • 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.

    PMID: 34617975BACKGROUND

MeSH Terms

Conditions

Rotavirus InfectionsMeningococcal Infections

Interventions

Rotavirus Vaccines

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Andrea Lo Vecchio, MD, PhD

    Federico II University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Lo Vecchio, MD, PhD

CONTACT

3395995538andrea.lovecchio@unina.it

Sara Maria Scarano, MD

CONTACT

3917741499scarano.sara91@gmail.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 28, 2022

Study Start

May 1, 2022

Primary Completion

October 1, 2022

Study Completion

April 1, 2023

Last Updated

March 17, 2022

Record last verified: 2022-03