Evidence map›Paper›PMID 41797351›Full record

ArticleInfection & chemotherapy2026

Post-Marketing Surveillance Study of the Live Attenuated Varicella Vaccine (SKYVaricella Inj.) in Korean Children.

Hyunjeong Kim, Kihyun Kim, Hye Young Kim

Abstract read
In one paragraph

Article in Infection & chemotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Hyunjeong KimMedical Affair, SK bioscience Co., Ltd., Incheon, Korea.ORCID https://orcid.org/0009-0001-1815-8901
Kihyun KimMedical Affair, SK bioscience Co., Ltd., Incheon, Korea.ORCID https://orcid.org/0009-0004-5146-4144
Hye Young KimMedical Affair, SK bioscience Co., Ltd., Incheon, Korea. hykim620@sk.com.ORCID https://orcid.org/0000-0001-9939-3737

Funding

SK bioscience
6 · The paper itself

Abstract

backgroundVaricella, caused by the varicella-zoster virus, is a highly contagious pediatric infection that can lead to severe complications. SKYVaricella Inj. (SK bioscience Co., Ltd, Incheon, Korea), a live-attenuated varicella vaccine developed by SK bioscience, was approved in Korea in 2018. This post-marketing surveillance study aimed to evaluate the safety profile of SKYVaricella Inj. (SK bioscience Co., Ltd, Korea) in children aged 12 months to 12 years in routine clinical practice. MATERIALS AND

methodsThis multicenter, prospective, non-interventional study was conducted across 25 sites in Korea from June 4, 2018, to June 3, 2022. A total of 623 subjects were included in the safety analysis. Adverse events (AEs), including those assessed as adverse drug reactions (ADRs), and serious adverse events (SAEs), were monitored for 42 days post-vaccination. Events were further categorized by causality and expectedness based on regulatory definitions. Descriptive statistics were used to summarize AE incidence and to explore potential associations with participant characteristics.

resultsAmong the 623 participants, 263 (42.2%) reported 514 AEs, and 56 (9.0%) experienced ADRs. The most frequently reported ADRs were injection site pain (4.0%), erythema (3.9%), and irritability (3.7%). Two SAEs (0.3%) - bronchitis and hand-foot-and-mouth disease - were reported and assessed as unrelated to vaccination. Varicella-like rashes occurred in 10 subjects (1.6%) and were mostly mild or moderate in severity. No unexpected serious adverse drug reactions were observed.

conclusionSKYVaricella Inj. (SK bioscience Co., Ltd, Korea) demonstrated an acceptable safety profile in pediatric use in Korea, with most AEs being mild and consistent with expected vaccine-related reactions. Continued pharmacovigilance and larger-scale studies are warranted to further support its long-term public health impact.

Indexed as

Product surveillance, postmarketingSafetyVaricella vaccineVaricella-zoster virus

Identifiers

PMID41797351
PMCPMC13053895

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.