UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective cohort study of the safety and persistence of immunity to SARS-CoV-2 vaccine in children in Izunokuni
Acronym	A retrospective cohort study of the safety and persistence of immunity to SARS-CoV-2 vaccine in children in Izunokuni
Scientific Title	A retrospective epidemiological study of the safety and persistence of immunity to SARS-CoV-2 vaccination in children
Scientific Title:Acronym	IzuNoKuni SARS-CoV-2 Vaccine Study in Children
Region	Japan

Condition
Condition	Children aged 5-11 years living in Izu no Kuni City, Shizuoka
Classification by specialty	Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The SARS-CoV-2, which has been spreading worldwide since 2019, has been spreading to children with the emergence of mutated strains. Vaccination against SARS-CoV-2 has been available in Japan since 2021. In Japan, vaccination against SARS-CoV-2 started in 2021, but children under 11 years of age have not yet been vaccinated. In March 2022, Juntendo University Shizuoka Hospital plans to take the lead in vaccinating children aged 5-11 years in Izu no Kuni City, Shizuoka Prefecture, in accordance with the expansion of the indication of the SARS-CoV-2 vaccine (Cominaty, Pfizer) to children. Therefore, we will conduct epidemiological studies of children who have been vaccinated with the new corona vaccine by collecting basic information on the children and their subsequent adverse reactions in a database managed by a questionnaire-based registration method as well as the Vaccination Facilitation System (V-SYS). In addition, for children who have given their consent to a backward-looking observational study, we would like to investigate subsequent adverse reactions, the spread of infection, and immune response. By analyzing these results, we will be able to evaluate the significance, safety, and persistence of immunity to the SARS-CoV-2 vaccine in children, which will provide important basic information for the control of infection.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Epidemiological study and safety assessment All children and their parents presenting for SARS-CoV-2 vaccination will be informed about the questionnaire and consenting patients will be allocated anonymously for enrolment. Children who agree to be observed retrospectively will be included in a separate database. The incidence of post-inoculation symptoms will be monitored, distinguishing between local and progressive adverse reactions.
Key secondary outcomes	Immune persistence A separate database will be created for children who agree to be observed retrospectively. Subsequent infection status and antibody testing (if desired) will be carried out.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	5 years-old <=
Age-upper limit	11 years-old >=
Gender	Male and Female
Key inclusion criteria	Children present in Izunokuni and vaccinated with SARS-CoV-2 vaccine (Cominaty, Pfizer)
Key exclusion criteria	Children presenting with fever at the time of vaccination The child is suffering from a serious acute illness. Children with conditions that make them inappropriate for vaccination. Any other person who is judged by the principal investigator to be unsuitable as a research subject.
Target sample size	1700

Research contact person
Name of lead principal investigator	1st name Yosuke Middle name Last name Baba
Organization	Juntendo University Shizuoka Hospital
Division name	Department of Pediatrics
Zip code	4102295
Address	1129 Nagaoka, Izunokuni, Shizuoka
TEL	0559483111
Email	youbaba@juntendo.ac.jp

Public contact
Name of contact person	1st name Yosuke Middle name Last name Baba
Organization	Juntendo University Shizuoka Hospital
Division name	Department of Pediatrics
Zip code	4102295
Address	1129 Nagaoka, Izunokuni, Shizuoka
TEL	0559483111
Homepage URL
Email	youbaba@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Juntendo University Shizuoka Hospital
Address	1129 Nagaoka, Izunokuni, Shizuoka
Tel	0559483111
Email	youbaba@juntendo.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2022 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date	2022 Year 03 Month 14 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

All children and their parents who come to the hospital for SARS-CoV-2 vaccination will be informed about the questionnaire survey and those who give consent will be allocated anonymously for registration. A separate database will be created for children who have consented to subsequent retrospective monitoring, including investigation of adverse reactions, subsequent infection status and antibody testing (if desired).

Management information
Registered date	2022 Year 02 Month 22 Day
Last modified on	2022 Year 02 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053600