Evidence map›Paper›PMID 41615771›Full record

Trial reportEmerging microbes & infections2026

Safety and immunogenicity of diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed after three-dose priming in 2 months age infants: a randomized, blinded, controlled phase III clinical trial in China.

Wei Zhang, Chen Wei, Peng Wan, Guangwei Feng, Feiyu Wang, Lichan Wang, Jiebing Tan, Xuewen Wang, Xue Wang, Xiuwen Sui and 7 more

Abstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Emerging microbes & infections, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. 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

17 authors.

Wei ZhangHenan Province Center for Disease Control and Prevention, Zhengzhou, People's Republic of China.
Chen WeiNational Institutes for Food and Drug Control, Beijing, People's Republic of China.
Peng WanCanSino Biologics Inc., Tianjin, People's Republic of China.
Guangwei FengHenan Province Center for Disease Control and Prevention, Zhengzhou, People's Republic of China.
Feiyu WangCanSino Biologics Inc., Tianjin, People's Republic of China.
Lichan WangNational Institutes for Food and Drug Control, Beijing, People's Republic of China.
Jiebing TanHenan Province Center for Disease Control and Prevention, Zhengzhou, People's Republic of China.
Xuewen WangShanghai Imstat medical technology CO., LTD, Shanghai, People's Republic of China.
Xue WangCanSino Biologics Inc., Tianjin, People's Republic of China.
Xiuwen SuiCanSino Biologics Inc., Tianjin, People's Republic of China.
Wangyang YouHenan Province Center for Disease Control and Prevention, Zhengzhou, People's Republic of China.
Jinbo GouCanSino Biologics Inc., Tianjin, People's Republic of China.
Liyong YuanNational Institutes for Food and Drug Control, Beijing, People's Republic of China.
Tao ZhuCanSino Biologics Inc., Tianjin, People's Republic of China.
Haitao HuangCanSino Biologics Inc., Tianjin, People's Republic of China.
Xiao MaNational Institutes for Food and Drug Control, Beijing, People's Republic of China.
Yanxia WangHenan Province Center for Disease Control and Prevention, Zhengzhou, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pertussis remains a leading cause of infant mortality globally, with rising cases in China post-COVID-19. Despite vaccination, waning immunity from acellular pertussis vaccines has driven resurgence. We evaluated a novel diphtheria, tetanus and pertussis (acellular, three components) combined vaccine, adsorbed (DTcP), China's first genetically engineered three-component pertussis vaccine, administered under two primary schedules (2/3/4 vs. 2/4/6 months) compared to licensed DTaP-IPV-Hib (Pentaxim). In this randomized, blinded, phase III clinical trial, 1380 healthy 2-month-old infants from Henan, China, received DTcP-1 (2/3/4 months) or DTcP-2 (2/4/6 months) or DTaP-IPV-Hib (2/3/4 months). The primary safety endpoints were the incidence of adverse reactions within 0∼30 days after primary vaccination. The primary immunogenicity endpoints were to evaluate the non-inferiority and superiority of seroconversion rates and geometric mean concentrations (GMCs) of anti-pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), diphtheria toxoid (DT), tetanus toxoid (TT), antibodies 30 days after primary vaccination. Immunogenicity was assessed via Luminex-based multiplex immunoassay. Both DTcP-1 and DTcP-2 schedules demonstrated non-inferior safety to DTaP-IPV-Hib (total adverse reactions: 14.52/16.59% vs. 16.91%,

Indexed as

DiphtheriaDiphtheria-Tetanus-acellular Pertussis VaccinesDiphtheria-Tetanus-Pertussis VaccineImmunogenicity, VaccineTetanusWhooping CoughAntibodies, BacterialBacterial Outer Membrane ProteinsBordetella pertussisChinaFemaleHumansImmunization ScheduleInfantMaleVaccinationAntibodies, BacterialBacterial Outer Membrane ProteinsDiphtheria-Tetanus-acellular Pertussis VaccinesDiphtheria-Tetanus-Pertussis VaccinepertactinVaccines, CombinedVirulence Factors, Bordetellaadsorbedclinical trialDiphtheriaimmunogenicityinfant immunizationsafetytetanus and pertussis (acellularthree components) combined vaccine

Identifiers

PMID41615771
PMCPMC12912230

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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.