UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059193 |
|---|---|
| Receipt number | R000067702 |
| Scientific Title | Study about the third booster varicella vaccination in children with primary vaccine failure after routine two-dose varicella vaccination |
| Date of disclosure of the study information | 2025/09/25 |
| Last modified on | 2025/09/25 19:21:40 |
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Basic information
Public title
Study about the third booster varicella vaccination
Acronym
The third booster varicella vaccination
Scientific Title
Study about the third booster varicella vaccination in children with primary vaccine failure after routine two-dose varicella vaccination
Scientific Title:Acronym
The third booster varicella vaccination after routine two-dose varicella vaccination
Region
| Japan |
Condition
Condition
varicella
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate prevalence of anti-VZV antibodies after routine two-dose varicella vaccination and evaluate immunogenicity and safety of the third booster varicella vaccination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the both antibody titers before and after the third booster varicella vaccination
Key secondary outcomes
1) Anti-VZV IAHA and gpELISA antibody titers after routine two-dose varicella vaccination
2) Incidence of clinical reactions for 4 weeks after the third booster varicella vaccination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
For the children that the agreement of the protector was obtained, we conduct blood sampling for measurement of anti-VZV antibody. We do booster varicella vaccination to children with less than 16 of IAHA antibody titers and conduct blood sampling for measurement of anti-VZV antibody 4-6 weeks later. We investigate clinical reactions (body temperature, rash, local reactions of the injection site, etc.) for 4 weeks after the booster vaccination.
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
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The children who came to this hospital for the purpose of the second MR vaccination and had received routine two-dose varicella vaccination in this hospital, and the children that protectors agreed to the study
Key exclusion criteria
The children of non-enforcement of antibody measurement before and after the two routine varicella vaccinations, and the children that the third booster varicella vaccination is inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Nishimura |
Organization
Konan Kosei Hospital
Division name
Department of Pediatrics
Zip code
483-8704
Address
137 Ohmatsubara, Takaya-cho, Konan, Aichi
TEL
0587-51-3333
naon@konan.jaaikosei.or.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Nishimura |
Organization
Konan Kosei Hospital
Division name
Department of Pediatrics
Zip code
483-8704
Address
137 Ohmatsubara, Takaya-cho, Konan, Aichi
TEL
0587-51-3333
Homepage URL
naon@konan.jaaikosei.or.jp
Sponsor or person
Institute
Konan Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
Konan Kosei Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Konan Kosei Hospital
Address
137 Ohmatsubara, Takaya-cho, Konan, Aichi
Tel
0587-51-3333
y-hirao@konan.jaaikosei.or.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
| 2025 | Year | 09 | Month | 25 | 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
| 2025 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067702
