Evidence map›Paper›PMID 36569946›Full record

Trial reportFrontiers in immunology2022

Immunogenicity and safety of an inactivated enterovirus 71 vaccine coadministered with trivalent split-virion inactivated influenza vaccine: A phase 4, multicenter, randomized, controlled trial in China.

Yaping Chen, Yanhui Xiao, Ying Ye, Feng Jiang, Hanqing He, Linyun Luo, Haiping Chen, Lubin Shi, Qiuyue Mu, Wei Chen and 6 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Frontiers in immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04091880 (A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
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.

NCT04091880 phase4completednot on this map

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine (Split Virion),Inactivated

TypeinterventionalSponsorChina National Biotec Group Company LimitedRan2019 to 2021Enrolled1,134ConditionsEnterovirus Infections, InfluenzaArmsEV71 vaccine and influenza vaccine, EV71 vaccine, influenza vaccine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Observational
  3. Review
  4. 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

16 authors at 4 institutions in 1 country.

Yaping ChenImmunization Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Yanhui XiaoMedical Affairs Department, China National Biotec Group Company Limited, Beijing, China.
Ying YeInstitute for Communicable Disease Control and Prevention, Henan Provincial Center for Disease Control and Prevention, Zhengzhou, Henan, China.
Feng JiangInstitute of Expanded Programme on Immunization, Guizhou Provincial Center for Disease Control and Prevention, Guiyang, Guizhou, China.
Hanqing HeImmunization Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Linyun LuoMedical Affairs Department, China National Biotec Group Company Limited, Beijing, China.
Haiping ChenMedical Affairs Department, China National Biotec Group Company Limited, Beijing, China.
Lubin ShiInstitute of Expanded Programme on Immunization, Henan Provincial Center for Disease Control and Prevention, Zhengzhou, Henan, China.
Qiuyue MuInstitute of Expanded Programme on Immunization, Guizhou Provincial Center for Disease Control and Prevention, Guiyang, Guizhou, China.
Wei ChenMedical Affairs Department, Wuhan Institute of Biological Products Company Limited, Wuhan, Hubei, China.
Xue GuoMedical Affairs Department, Changchun Institute of Biological Products Company Limited, Changchun, Jilin, China.
Min ZhangMedical Affairs Department, China National Biotec Group Company Limited, Beijing, China.
Jun LiInstitute of Expanded Programme on Immunization, Henan Provincial Center for Disease Control and Prevention, Zhengzhou, Henan, China.
Qinghu GuanInstitute of Expanded Programme on Immunization, Guizhou Provincial Center for Disease Control and Prevention, Guiyang, Guizhou, China.
Zhiping ChenImmunization Programme Department, Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Xiaoming YangMedical Affairs Department, China National Biotec Group Company Limited, Beijing, China.
Guizhou Center for Disease Control and Prevention · CNHenan Provincial Center for Disease Control and Prevention · CNZhejiang Center for Disease Control and Prevention · CNChangchun Institute of Biological Products · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Few data exist on the immunogenicity and safety of an inactivated enterovirus 71 vaccine (EV71 vaccine) coadministered with trivalent split-virion inactivated influenza vaccine (IIV3) in infants. Methods: This trial was a phase 4, randomized, controlled trial. Infants aged 6-11 months were eligible, with no history of hand, foot and mouth disease (HFMD) and no history of EV71 vaccine or any influenza vaccine. Eligible infants were randomly assigned to EV71+IIV3 group, EV71 group or IIV3 group. Blood samples were collected on day 0 and 56. Results: Between September 2019 and June 2020, 1151 infants met eligibility criteria and 1134 infants were enrolled. 1045 infants were included in the per-protocol population, including 347 in the EV71+IIV3 group, 343 in the EV71 group, and 355 in the IIV3 group. The seroconversion rate (98.56% vs 98.54%; seroconversion rates difference of 0.02% [95% CI: 0.70-0.98]) and GMT (419.05 vs 503.72; GMT ratio of 0.83 [95% CI 0.70 - 0.98]) of EV71 neutralizing antibodies in the EV71+IIV3 group was not inferior to those in the EV71 group. The non-inferiority results for influenza virus antibodies (A/H1N1, A/H3N2 and B) showed that the seroconversion rates and GMTs of the EV71+IIV3 group were non-inferiority to those of the IIV3 group. Systemic and local adverse event rates were similar between groups. None of serious adverse events (SAEs) were related to vaccination. Conclusions: Coadministration of the EV71 vaccine with IIV3 was safe and did not interfere with immunogenicity. These findings support a viable immunization strategy for infants with the EV71 vaccine coadministered with IIV3 in China. This trial is registered with ClinicalTrials.gov, number NCT04091880.

Indexed as

Enterovirus A, HumanHIV SeropositivityInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesChinaHemagglutination Inhibition TestsHumansInfantInfluenza A Virus, H3N2 SubtypeVaccines, InactivatedVirionInfluenza VaccinesVaccines, Inactivatedcoadministrationimmunogenicityinactivated enterovirus 71 vaccinesafetytrivalent split-virion inactivated influenza vaccine

Identifiers

PMID36569946
PMCPMC9772018
OpenAlexW4311850658

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.