Tokyo, Sept. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059193) titled 'Study about the third booster varicella vaccination' on Sept. 25.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Konan Kosei Hospital
Condition:
Condition - varicella
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 5
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 Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 17 Day
Anticipated trial start date - 2025 Year 10 Month 01 Day
Last follow-up date - 2029 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067702
Disclaimer: Curated by HT Syndication.
