Evidence map›Paper›PMID 39540202›Full record

Trial reportHuman vaccines & immunotherapeutics2024

Safety and immunogenicity of full-dose quadrivalent influenza vaccine in children 6-35 months of age in China: A randomized, double-blind, clinical trial.

Shilei Wang, Yanxia Wang, Dandan Chen, Wenting Xu, Peng Duan, Wei Ji, Weijun Liu, Weijin Huang, Bing Wu, Wenqing Chai and 5 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. 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

15 authors.

Shilei WangResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, China.
Yanxia WangVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhengzhou, Henan, China.
Dandan ChenResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, China.
Wenting XuResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, China.
Peng DuanResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, China.
Wei JiProduction Department, Shanghai Institute of Biological Products, Shanghai, China.
Weijun LiuProduction Department, Shanghai Institute of Biological Products, Shanghai, China.
Weijin HuangInstitute for Biological Product Control, National Institutes for Food and Drug Control, Beijing, China.
Bing WuResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, China.
Wenqing ChaiResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, China.
Chenyan ZhaoInstitute for Biological Product Control, National Institutes for Food and Drug Control, Beijing, China.
Yongli YangCollege of Public Health, Zhengzhou University, Zhengzhou, Henan, China.
Jian LuoResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, China.
Dongyang ZhaoVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhengzhou, Henan, China.
Xiuling LiResearch and Development Department, Shanghai Institute of Biological Products, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A half-dose influenza vaccine (7.5 μg hemagglutinin per strain) has been used for children under 3 years of age for a long time. However, several studies indicate that a full-dose influenza vaccine (15 μg hemagglutinin per strain) may bring more benefit to this population without increasing the risk of adverse reactions. We conducted a clinical study in children aged 6-35 months in China. Participants were randomized to receive two doses of full-dose quadrivalent influenza vaccine (F-QIV), half-dose quadrivalent vaccine (H-QIV), and two half-dose trivalent vaccines (H-TIV) in a 2:2:1:1 ratio. The safety and tolerability profile of the vaccine was evaluated for 6 months postvaccination. Hemagglutination inhibition (HI) antibody titers were measured for immunogenicity assessment. The primary objective was to assess whether the results of all vaccines met the criteria. A total of 1,980 participants were enrolled in the study. Both H-QIV and F-QIV were well tolerated after vaccination. Although the geometric mean increase (GMI), seroconversion rate (SCR), and seroprotection rate (SPR) for both H-QIV and F-QIV were achieved by the criteria, superior immunogenicity in terms of geometric mean titer (GMT) ratio was observed in F-QIV to H-QIV for A/H3N2 (GMT ratio (95% CI) of 1.37 (1.11 ~ 1.68)) and B/Yamagata (1.21 (1.05 ~ 1.39)). Antibody responses to the QIV were non-inferior to the response to the TIV for the matched strains. In conclusion, F-QIV and H-QIV were both safe and immunogenic for children. F-QIV induced a stronger immune response to influenza viruses and may provide more protection and benefit by promoting the use of F-QIV in children aged 6-35 months.

Indexed as

Antibodies, ViralHemagglutination Inhibition TestsInfluenza, HumanInfluenza VaccinesChild, PreschoolChinaDouble-Blind MethodFemaleHumansImmunogenicity, VaccineInfantInfluenza A Virus, H3N2 SubtypeMaleAntibodies, ViralInfluenza Vaccines6–35 monthsclinical trailsfull-doseimmunogenicityQuadrivalent influenza vaccinesafety

Identifiers

PMID39540202
PMCPMC11572236

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.