Evidence map›Paper›PMID 42483174›Full record

Trial reportFrontiers in immunology2026

Immunogenicity and safety of primary three-dose series with diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed in 3 months infants.

Wei Zhang, Chen Wei, Haitao Huang, Xue Wang, Zhiqiang Xie, Yan Wu, Feiyu Wang, Lili Huang, Xuewen Wang, Xiuwen Sui and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05951725 (A Randomized, Blinded, Positive Vaccine-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of DTcP in Infants and Children at 2 and 3 Months of Age), which is not on this 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.

NCT05951725 phase3active not recruitingnot on this map

A Randomized, Blinded, Positive Vaccine-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of DTcP in Infants and Children at 2 and 3 Months of Age

TypeinterventionalSponsorCanSino Biologics Inc.Ran2023 to 2025Enrolled2,520ConditionsDiphtheria, Tetanus and Acellular PertussisArmsDiphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP), Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP, Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib, DTcP, DTaP-IPV-Hib
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

18 authors.

Wei Zhang *Henan Provincial Center for Disease Control and Prevention, Henan Key Laboratory of Infectious Pathogenic Microbiology, Zhengzhou, China.
Chen Wei *National Institutes of Food and Drug Control, Beijing, China.
Haitao Huang *CanSino Biologics Inc., Tianjin, China.
Xue WangCanSino Biologics Inc., Tianjin, China.
Zhiqiang XieHenan Provincial Center for Disease Control and Prevention, Henan Key Laboratory of Infectious Pathogenic Microbiology, Zhengzhou, China.
Yan WuNational Institutes of Food and Drug Control, Beijing, China.
Feiyu WangCanSino Biologics Inc., Tianjin, China.
Lili HuangHenan Provincial Center for Disease Control and Prevention, Henan Key Laboratory of Infectious Pathogenic Microbiology, Zhengzhou, China.
Xuewen WangShanghai Imstat Medical Technology CO., LTD, Shanghai, China.
Xiuwen SuiCanSino Biologics Inc., Tianjin, China.
Peng WanCanSino Biologics Inc., Tianjin, China.
Zhe ChaoNational Institutes of Food and Drug Control, Beijing, China.
Jinbo GouCanSino Biologics Inc., Tianjin, China.
Bozhi ShiNational Institutes of Food and Drug Control, Beijing, China.
Jia LiuHenan Provincial Center for Disease Control and Prevention, Henan Key Laboratory of Infectious Pathogenic Microbiology, Zhengzhou, China.
Tao ZhuCanSino Biologics Inc., Tianjin, China.
Liyong YuanNational Institutes of Food and Drug Control, Beijing, China.
Yanxia WangHenan Provincial Center for Disease Control and Prevention, Henan Key Laboratory of Infectious Pathogenic Microbiology, Zhengzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study aimed to evaluate the safety and immunogenicity of a novel diphtheria, tetanus, and pertussis (acellular, three components) combined vaccine, adsorbed (DTcP) vaccine compared to the existing co-purified DTaP vaccine in China. In this partially randomized, blinded, controlled Phase III trial, we assessed a DTcP vaccine against two controls: a licensed co-purified DTaP and a DTaP-IPV-Hib vaccine. A total of 1,140 infants (3 months old) received a 3-dose primary series at 3, 4, and 5 months. Both of DTcP and co-purified DTaP had lower incidences of overall adverse reactions than the DTaP-IPV-Hib vaccine (17.99%/18.08% vs. 21.96%). The DTcP vaccine demonstrated non-inferiority and superiority over the co-purified DTaP for anti-PT and anti-FHA immunogenicity. In addition, the DTcP achieved a 98.16% seroconversion rate for anti-FHA, versus only 14.29% for the co-purified DTaP. Besides, DTcP vaccine also induced high antibody level in GMC results. Specifically, the anti-PT GMC was 85.10 in the DTcP group versus 49.86 in the DTaP group ( Clinical trial registration: ClinicalTrial.gov, identifier NCT05951725.

Indexed as

DiphtheriaDiphtheria-Tetanus-acellular Pertussis VaccinesDiphtheria-Tetanus-Pertussis VaccineImmunogenicity, VaccineTetanusWhooping CoughAntibodies, BacterialChinaFemaleHumansImmunization ScheduleInfantMaleVaccinationVaccines, CombinedAntibodies, BacterialDiphtheria-Tetanus-acellular Pertussis VaccinesDiphtheria-Tetanus-Pertussis VaccineVaccines, Combinedclinical trialco-purified DTaPDTcPimmunogenicitysafety

Identifiers

PMID42483174
PMCPMC13385028

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Registered trials

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.