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Immunogenicity and safety profiles of a new MAV/06 strain varicella vaccine in healthy children: A multinational, multicenter, randomized, double-blinded, active-controlled phase III study

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Author(s)
Ui Yoon ChoiKi Hwan KimJin LeeByung Wook EunDong Ho KimSang Hyuk MaChun Soo KimKeswadee LapphraAuchara TangsathapornpongPope KosalaraksaPeninnah OberdorferHwang Min KimSon Moon ShinJin Han Kang
Keimyung Author(s)
Kim, Chun Soo
Department
Dept. of Pediatrics (소아청소년학)
Journal Title
Vaccine
Issued Date
2021
Volume
39
Issue
12
Keyword
Varicella VaccineMAV/06 strainPhase 3 Clinical trialDouble blindImmunogenicitySafetyMulticenterMultinationalChildren
Abstract
Immunization is the most effective preventive strategy against varicella. While the Oka strain is commonly used for varicella vaccination worldwide, Korea widely uses the MAV/06 strain. A new live attenuated MAV/06 strain varicella vaccine (MG1111), which uses the new cell line Medical Research Council-5 for better viral propagation, was developed. MG1111 was approved by Korean health authorities. Here, we report the results of phase III, randomized, double–blind, multicenter study conducted in Korea and Thailand, which compared the immunogenicity and safety profiles of MG1111 versus the control vaccine, Varivax TM . In total, 515 healthy children (12 month–12 years) were randomized 1:1 to receive either the MG1111 or control vaccine (MG1111: 258, Control: 257). The seroconversion rate (SCR) and geometric mean titer (GMT) were measured using the fluorescent antibody to membrane antigen (FAMA) test. The MG1111 group achieved a SCR of 97.9% (95% CI: 95.2–99.3) after vaccination. The lower limit of 95% CI for SCR difference (MG1111-Varivax TM ) was –4.0%, which was higher than the specified non-inferiority margin of –10%. Further, the GMT of the MG1111 increased from 2.0 to 74.2 (95% CI: 65.0–84.8) and the lower limits of the 95% CI for post–vaccination GMT ratios (MG1111/Varivax TM ) were 0.55 higher than the specified parameter of 0.5. Therefore, the MG1111 group was not statistically inferior to the control vaccine group in terms of SCR and GMT. Furthermore, the MG1111 and control vaccine groups were not significantly different in the percentage of participants showing adverse events—solicited, local, or systemic during 43-day period of observation and serious adverse events during 6 month of observation. The present results indicate that MG1111was not immunologically inferior to Varivax TM , and safety profiles of MG1111 are similar to those of Varivax TM .
Keimyung Author(s)(Kor)
김천수
Publisher
School of Medicine (의과대학)
Citation
Ui Yoon Choi et al. (2021). Immunogenicity and safety profiles of a new MAV/06 strain varicella vaccine in healthy children: A multinational, multicenter, randomized, double-blinded, active-controlled phase III study. Vaccine, 39(12), 1758–1764. doi: 10.1016/j.vaccine.2021.02.013
Type
Article
ISSN
1873-2518
Source
https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0264410X21001614
DOI
10.1016/j.vaccine.2021.02.013
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/43664
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Pediatrics (소아청소년학)
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