VaccinationSTORMNCT05212935
A Surveillance Study on Timing and Coverage Of Rotavirus and MenB Vaccine Co-administration in Campania Region, Italy
An observational study of Vaccination and Rotavirus Infections, run by Federico II University.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 weeks to 12 months
- Conditions the study is for
- Vaccination, Rotavirus Infections, Meningococcal Infections
- What is being tested?
- Rotavirus Vaccine
- Type of treatment
- Vaccines
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: children receiving vaccination in their first year of life at one of the Vaccination Centers involved in the study
Who may be able to join
- all children receiving vaccination according to the Italian National Vaccine Prevention Plan 2017-2019
Who cannot join
- primary outcomes data missing.
Trial locations and contacts
No sites are listed yet.
About this study
A two-phases study will be carried out with the following aims
- st phase (2018-2020)
Read more
- 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.
Read the 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:
- 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.
- 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
- Vaccination, Rotavirus Infections, Meningococcal Infections
- Being tested
- Rotavirus Vaccine
- Keywords
- Vaccination coverage, Rotavirus, Meningococcus
- Medical subject headings
- Rotavirus Infections, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotavirus VaccineBiological
administration of the 3 doses of Rotavirus human bovine pentavalent reassortant vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Rotavirus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall proportion of children fully immunized for RV and proportion of immunized children in each subgroup
Measured: 32 weeks
Proportion of children receiving the first RV5 dose within 12 weeks of age
Measured: 32 weeks
Proportion of children completing RV5 schedule within 32 weeks of age
Measured: 32 weeks
Proportion of children receiving the co-administration RV5 + MenB
Measured: 32 weeks
Secondary outcomes (3)
Proportion of children partially immunized (1 or 2 doses) or not immunized for RV in each subgroup
Measured: 32 weeks
Proportion of children receiving RV5 immunization doses alone
Measured: 32 weeks
Proportion of children receiving the co-administration of RV5+hexavalent/PCV
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study startMay 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Andrea Lo Vecchio, MD, PhD, Federico II University
- Investigators
- Andrea Lo Vecchio, MD, PhD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212935
- Sponsor's protocol ID
- 432/21
- Acronym
- STORM
- Status last verified
- Mar 2022
- First submitted
- 21 Dec 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29576308Lo 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.
PubMed 28216189Foster 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.
PubMed 23055840O'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.
PubMed 24338083DeSilva 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.
PubMed 34617975
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Surveillance Study on Timing and Coverage Of Rotavirus and MenB Vaccine Co-administration in Campania Region, Italy
- ClinicalTrials.gov ID
- NCT05212935
- Acronym / sponsor ID
- STORM / 432/21
- Conditions
- Vaccination, Rotavirus Infections, Meningococcal Infections
- Keywords
- Vaccination coverage, Rotavirus, Meningococcus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A two-phases study will be carried out with the following aims
- 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
- 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.
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:
- 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.
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children below 12 months of age receiving vaccines according to the National Vaccination Plan | – | Biological: Rotavirus VaccineAll 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. |
Who may qualify
- Ages
- 6 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children receiving vaccination in their first year of life at one of the Vaccination Centers involved in the study
Key inclusion criteria (1 listed)
- all children receiving vaccination according to the Italian National Vaccine Prevention Plan 2017-2019
Key exclusion criteria (1 listed)
- primary outcomes data missing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotavirus Vaccineadministration of the 3 doses of Rotavirus human bovine pentavalent reassortant vaccine | Biological | Children below 12 months of age receiving vaccines according to the National Vaccination Plan |
Primary outcome
Overall proportion of children fully immunized for RV and proportion of immunized children in each subgroup
Time frame: 32 weeks
Proportion of children receiving the first RV5 dose within 12 weeks of age
Time frame: 32 weeks
Proportion of children completing RV5 schedule within 32 weeks of age
Time frame: 32 weeks
Proportion of children receiving the co-administration RV5 + MenB
Time frame: 32 weeks
3 secondary outcomes
Proportion of children partially immunized (1 or 2 doses) or not immunized for RV in each subgroup
Time frame: 32 weeks
Proportion of children receiving RV5 immunization doses alone
Time frame: 32 weeks
Proportion of children receiving the co-administration of RV5+hexavalent/PCV
Time frame: 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 29576308Poelaert 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.
- Background: PubMed 28216189Lo 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.
- Background: PubMed 23055840Foster 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.
- Background: PubMed 24338083O'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.
- Background: PubMed 34617975DeSilva 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Lo Vecchio, MD, PhD principal investigator
Federico II University
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccination and Rotavirus Infections, run by Federico II University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Lo Vecchio, MD, PhD (3395995538, andrea.lovecchio@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall proportion of children fully immunized for RV and proportion of immunized children in each subgroup (time frame: 32 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05212935, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.