Evidence map›Paper›PMID 41318685›Full record

Trial reportNature communications2025

Immunogenicity and safety of co-purified diphtheria, tetanus and acellular pertussis vaccine in 6-year-old Chinese children.

Xuewen Tang, Yanhui Xiao, Jinhua Chen, Ying Su, Yang Zhou, Linyun Luo, Jiayou Zhang, Shaoxiang Liu, Rui Yan, Dewu Zhu and 7 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05870631 (Immunogenicity and Safety of Adsorbed Diphtheria, Tetanus, Acellular Pertussis Combined Vaccine or Adsorbed Diphtheria Tetanus Combined Vaccine in 6 Years Old Children#a Randomized, Controlled Clinical Study), which is not on this 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.

NCT05870631 phase4unknown statusnot on this map

Immunogenicity and Safety of Adsorbed Diphtheria, Tetanus, Acellular Pertussis Combined Vaccine or Adsorbed Diphtheria Tetanus Combined Vaccine in 6 Years Old Children#a Randomized, Controlled Clinical Study

TypeinterventionalSponsorZhejiang Provincial Center for Disease Control and PreventionRan2023 to 2024Enrolled480ConditionsVaccine ReactionArmsvaccinate with DTaP, vaccinate with DT
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  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

17 authors.

Xuewen Tang *Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.
Yanhui Xiao *China National Biotec Group Company Limited, Beijing, China.
Jinhua Chen *Yiwu Center for Disease Control and Prevention, Jinhua, China.
Ying SuZhejiang Chinese Medical University, Hangzhou, China.
Yang ZhouZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.
Linyun LuoChina National Biotec Group Company Limited, Beijing, China.
Jiayou ZhangWuhan Institute of Biological Products Company Limited, Wuhan, China.
Shaoxiang LiuChengdu Institute of Biological Products Company Limited, Chengdu, China.
Rui YanZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.
Dewu ZhuWuhan Institute of Biological Products Company Limited, Wuhan, China.
Wei ZhaoChengdu Institute of Biological Products Company Limited, Chengdu, China.
Yao ZhuZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China.
Xiao MaNational Institutes of Food and Drug Control, Beijing, China.
Yuli JiangHarvest integrated Research Organization (HiRO), Shanghai, China.
Hailong PanChina National Biotec Group Company Limited, Beijing, China.
Yuntao ZhangChina National Biotec Group Company Limited, Beijing, China.
Hanqing HeZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, China. hanqinghe@cdc.zj.cn.ORCID http://orcid.org/0000-0003-0863-5177

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In recent years, China has experienced a rapid increase in the number of pertussis cases among children aged 5 to 9. We conducted this phase 4 randomized, controlled trial (NCT05870631) in Zhejiang Province, China, to compare the immunogenicity and safety of co-purified diphtheria, tetanus, and acellular pertussis combined vaccine (co-purified DTaP) to diphtheria and tetanus combined vaccine (DT) in 6-year-old children. Between April 2023 to July 2023, 480 participants were randomized to receive one dose of co-purified DTaP (n = 240) or DT (n = 240). 28 days after vaccination, the seroconversion rates of the co-purified DTaP were 81.20% for anti-PT and 74.36% for anti-FHA, and achieved a significantly higher rate for anti-tetanus compared to the DT vaccine (97.01% vs. 87.05%, P < 0.001). Both vaccines showed 100% seroconversion for anti- diphtheria antibody. For all antibody types, the co-purified DTaP can induced higher geometric mean concentrations. More vaccine-related adverse events were reported with the co-purified DTaP. Most of the severity occurred in Grade 1 and 2. The booster dose of co-purified DTaP vaccination is safe and induces a significant anti-pertussis antibody response, it may be feasible to give a booster dose of co-purified DTaP instead of the recommended DT for 6-year-old children in China.

Indexed as

Diphtheria-Tetanus-acellular Pertussis VaccinesImmunogenicity, VaccineWhooping CoughAntibodies, BacterialChildChinaDiphtheriaEast Asian PeopleFemaleHumansMaleSeroconversionTetanusVaccinationAntibodies, BacterialDiphtheria-Tetanus-acellular Pertussis Vaccines

Identifiers

PMID41318685
PMCPMC12780235

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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.