Evidence map›Paper›PMID 39895085›Full record

Trial reportHuman vaccines & immunotherapeutics2025

Immunogenicity and safety of a live attenuated varicella vaccine in children aged 1 to 12 years: A double-blind, randomized, parallel-controlled phase III clinical trial in China.

Shiyuan Wang, Yang Zhang, Guifan Li, Jinhui Shi, Xianyun Chang, Hao Zhang, Fengcai Zhu, Jingxin Li, Kai Chu, Jinfang Sun

Abstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
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

10 authors.

Shiyuan WangDepartment of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, PR China.
Yang ZhangDepartment of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, PR China.
Guifan LiRegistration Department, Beijing Minhai Biotechnology Co., Ltd, BeiJing, China.
Jinhui ShiRegistration Department, Beijing Minhai Biotechnology Co., Ltd, BeiJing, China.
Xianyun ChangRegistration Department, Beijing Minhai Biotechnology Co., Ltd, BeiJing, China.
Hao ZhangRegistration Department, Beijing Minhai Biotechnology Co., Ltd, BeiJing, China.
Fengcai ZhuVaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR China.ORCID 0000-0002-1644-0006
Jingxin LiVaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR China.
Kai ChuVaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR China.
Jinfang SunDepartment of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, PR China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chickenpox outbreaks frequently occur in collective settings such as kindergartens and schools, posing a significant threat to children's physical and mental health. This study aimed to evaluate the immunogenicity and safety of the freeze-dried live attenuated varicella vaccine (VarV) developed by Beijing Minhai Biotechnology Co. LTD. in healthy participants aged 1-12 years. In this phase III, single-center, randomized, double-blind, active-controlled trial,1,200 healthy participants randomly assigned in a 1:1 ratio to receive one dose of either the test vaccine or the active control vaccine. Venous blood samples were collected before vaccination and 42 days after vaccination, and the fluorescent antibody to membrane antigen (FAMA) assay was used to detect VZV antibody. Adverse events (AEs) observed within 42 days after vaccination and serious adverse events (SAEs) within six months after vaccination were recorded. The seroconversion rates in the test and control groups were 96.79% and 96.43%, respectively, with a difference of 0.36% (95% CI, -1.76%-2.48%). The geometric mean titers (GMTs) were 61.74 and 58.04, respectively, with a difference of 1.06 (95% CI, 0.92-1.23). The lower limits of the 95% CI for the differences in seroconversion rates and GMT ratios between the two groups were greater than their respective pre-set non-inferiority margins. The overall incidence of AEs (

Indexed as

ChickenpoxChickenpox VaccineImmunogenicity, VaccineAntibodies, ViralChildChild, PreschoolChinaDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFemaleHerpesvirus 3, HumanHumansInfantMaleVaccines, AttenuatedAntibodies, ViralChickenpox VaccineVaccines, Attenuatedchickenpoximmunogenicitypediatricphase IIIsafetyVaricella vaccine

Identifiers

PMID39895085
PMCPMC11792797

What OpenQuestion holds

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Registered trials

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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.