Evidence map›Paper›PMID 39993940›Full record

Trial reportHuman vaccines & immunotherapeutics2025

Immunogenicity and safety of 1 versus 2 doses of quadrivalent-inactivated influenza vaccine in children aged 3-8 years with or without previous influenza vaccination histories.

Feng Wen, Sheng Liu, Li Zhou, Yinbiao Zhu, Wenjuan Wang, Mingwei Wei, Xinglong Xu, Yan Liu, Qi Shuai, Jun Yu and 3 more

Abstract readClinical Trial, Phase IV
PubMed Full text at PMC Publisher
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. Review
  2. Review
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

13 authors.

Feng WenSchool of Public Health, Southeast University, Nanjing, China.
Sheng LiuDepartment of Disease Control and Prevention, Pizhou City Center for Disease Control and Prevention, Xuzhou, China.
Li ZhouDepartment of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, China.
Yinbiao ZhuResearch and Development Department, Jiangsu GDK Biological Technology Co. Ltd, Taizhou, China.
Wenjuan WangDepartment of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, China.
Mingwei WeiDepartment of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, China.
Xinglong XuResearch and Development Department, Jiangsu GDK Biological Technology Co. Ltd, Taizhou, China.
Yan LiuResearch and Development Department, Jiangsu GDK Biological Technology Co. Ltd, Taizhou, China.
Qi ShuaiResearch and Development Department, Jiangsu GDK Biological Technology Co. Ltd, Taizhou, China.
Jun YuResearch and Development Department, Jiangsu GDK Biological Technology Co. Ltd, Taizhou, China.
Pengfei JingDepartment of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Academy of Preventive Medicine), Nanjing, China.
Jingxin LiSchool of Public Health, Southeast University, Nanjing, China.ORCID 0000-0002-7033-5151
Fengcai ZhuSchool of Public Health, Southeast University, Nanjing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study assessed the immunogenicity and safety of a quadrivalent influenza split-virion vaccine (IIV4) in children with and without prior influenza vaccination. An open-label, phase IV clinical trial was conducted in healthy children aged 3-8 years in Pizhou, Jiangsu Province, China. Children with ≥2 doses of prior influenza vaccination (Influenza Vaccination Group) and those with no prior vaccination (Influenza Vaccine-naïve Group) were given two doses of IIV4, 4 weeks apart. The primary immunogenicity endpoints were seroprotection rates (SPRs) of hemagglutination inhibition antibody 28 days after each dose against influenza A/H1N1, A/H3N2, B/Yamagata (BY), and B/Victoria (BV). Safety endpoints included adverse events (AEs) within 28 days and serious adverse events (SAEs) within 6 months. Between September 19-25, 2021, 278 participants were screened, and 240 were enrolled (120 per group). In the Influenza Vaccination Group, SPRs after the 2nd dose were 98.28%, 92.24%, 99.14%, and 87.93%, similar to those after the 1st dose (all

Indexed as

Immunogenicity, VaccineInfluenza, HumanInfluenza VaccinesAntibodies, ViralChildChild, PreschoolChinaFemaleHemagglutination Inhibition TestsHumansImmunization ScheduleInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza B virusMaleVaccinationAntibodies, ViralInfluenza VaccinesVaccines, Inactivated1 versus 2 dosesimmunogenicityInactivated influenza vaccineprevious influenza vaccinationsafety

Identifiers

PMID39993940
PMCPMC11853548

What OpenQuestion holds

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LicenceCC BY-NC
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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.