Evidence map›Paper›PMID 35931636›Full record

Trial reportVaccine2022

Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: A multicentre, non-inferiority, open-label, randomised, controlled, phase 4 trial.

Haiping Chen, Zhuoying Huang, Shaoying Chang, Mei Hu, Qingbin Lu, Yuntao Zhang, Hui Wang, Yanhui Xiao, Hui Wang, Yonghong Ge and 16 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04790851 (A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.5field-weighted citation impact, top 9% 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.

NCT04790851 phase4completednot on this map

A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines (Vero Cell) (COVAX) (Produced in Beijing) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)

TypeinterventionalSponsorChina National Biotec Group Company LimitedRan2021 to 2021Enrolled1,133ConditionsInfluenza, Human, Pneumonia, Pneumococcal, Covid19ArmsCOVAX+IIV4, COVAX+PPV23, COVAX only (1st and 2nd dose), IIV4 for the 1st dose and PPV23 for the 2nd dose
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
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  5. Immunogenicity and Safety of the COVID-19 Messenger RNA Vaccine Coadministered With Influenza and 23-valent Pneumococcal Polysaccharide Vaccines.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
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  7. Review
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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

26 authors at 8 institutions in 1 country.

Haiping ChenChina National Biotec Group Company Limited, Beijing, China.
Zhuoying HuangShanghai Municipal Center for Disease Control and Prevention, Shanghai, China.
Shaoying ChangShanxi Provincial Center for Disease Control and Prevention, Taiyuan, China.
Mei HuSichuan Center for Disease Control and Prevention, Chengdu, China.
Qingbin LuDepartment of Laboratorial Science and Technology & Vaccine Research Center, School of Public Health, Peking University, Beijing, China.
Yuntao ZhangChina National Biotec Group Company Limited, Beijing, China.
Hui WangShanxi Provincial Center for Disease Control and Prevention, Taiyuan, China.
Yanhui XiaoChina National Biotec Group Company Limited, Beijing, China.
Hui WangBeijing Institute of Biological Products Company Limited, Beijing, China.
Yonghong GeChengdu Institute of Biological Products Company Limited, Chengdu, China.
Yong ZouChangchun Institute of Biological Products Company Limited, Changchun, China.
Fuqiang CuiDepartment of Laboratorial Science and Technology & Vaccine Research Center, School of Public Health, Peking University, Beijing, China.
Shasha HanChina National Biotec Group Company Limited, Beijing, China.
Min ZhangChina National Biotec Group Company Limited, Beijing, China.
Shengyi WangChina National Biotec Group Company Limited, Beijing, China.
Xiaoping ZhuSichuan Center for Disease Control and Prevention, Chengdu, China.
Biao ZhangSantai County Center for Disease Control and Prevention, Mianyang, China.
Zhi LiShanghai Municipal Center for Disease Control and Prevention, Shanghai, China.
Jia RenShanghai Municipal Center for Disease Control and Prevention, Shanghai, China.
Xiao ChenShanxi Provincial Center for Disease Control and Prevention, Taiyuan, China.
Rui MaBeijing Institute of Biological Products Company Limited, Beijing, China.
Lei ZhangChengdu Institute of Biological Products Company Limited, Chengdu, China.
Xue GuoChangchun Institute of Biological Products Company Limited, Changchun, China.
Linyun LuoChina National Biotec Group Company Limited, Beijing, China.
Xiaodong SunShanghai Municipal Center for Disease Control and Prevention, Shanghai, China. Electronic address: sunxiaodong@scdc.sh.cn.
Xiaoming YangChina National Biotec Group Company Limited, Beijing, China; National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Company Limited, Wuhan, China. Electronic address: yangxiaoming@sinopharm.com.
Jiangsu Provincial Center for Disease Control and Prevention · CNShanghai Municipal Center For Disease Control Prevention · CNChangchun Institute of Biological Products · CNMianyang City Center for Disease Control and Prevention · CNNational Vaccine and Serum Institute · CNPeking University · CNSichuan Center for Disease Control and Prevention · CNChengdu Institute of Biology · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe safety and immunogenicity of the coadministration of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV), quadrivalent split-virion inactivated influenza vaccine (IIV4), and 23-valent pneumococcal polysaccharide vaccine (PPV23) in adults in China is unknown.

methodsIn this open-label, non-inferiority, randomised controlled trial, participants aged ≥ 18 years were recruited from the community. Individuals were eligible if they had no history of SARS-CoV-2 vaccine or any pneumonia vaccine and had not received an influenza vaccine during the 2020-21 influenza season. Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either: SARS-CoV-2 vaccine and IIV4 followed by SARS-CoV-2 vaccine and PPV23 (SARS-CoV-2 + IIV4/PPV23 group); two doses of SARS-CoV-2 vaccine (SARS-CoV-2 vaccine group); or IIV4 followed by PPV23 (IIV4/PPV23 group). Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28 before vaccination, and on day 56.

resultsBetween March 10 and March 15, 2021, 1152 participants were recruited and randomly assigned to three groups (384 per group). 1132 participants were included in the per-protocol population (375 in the SARS-CoV-2 + IIV4/PPV23 group, 380 in the SARS-CoV-2 vaccine group, and 377 in the IIV4/PPV23 group). The seroconversion rate (100 % vs 100 %) and GMT (159.13 vs 173.20; GMT ratio of 0.92 [95 % CI 0.83 to 1.02]) of SARS-CoV-2 neutralising antibodies in the SARS-CoV-2 + IIV4/PPV23 group was not inferior to those in the SARS-CoV-2 vaccine group. The SARS-CoV-2 + IIV4/PPV23 group was not inferior to the IIV4/PPV23 group in terms of seroconversion rates and GMT of influenza virus antibodies for all strains except for the seroconversion rate for the B/Yamagata strain. The SARS-CoV-2 + IIV4/PPV23 group was not inferior to the IIV4/PPV23 group regarding seroconversion rates and GMC of Streptococcus pneumoniae IgG antibodies specific to all serotypes. All vaccines were well tolerated.

conclusionsThe coadministration of the inactivated SARS-CoV-2 vaccine and IIV4/PPV23 is safe with satisfactory immunogenicity. This study is registered with ClinicalTrials.gov, NCT04790851.

Indexed as

COVID-19COVID-19 VaccinesImmunogenicity, VaccineInfluenza, HumanInfluenza VaccinesPneumococcal InfectionsPneumococcal VaccinesAdultAntibodies, ViralChinaDouble-Blind MethodHemagglutination Inhibition TestsHumansInfluenza B virusSARS-CoV-2Vaccines, CombinedAntibodies, ViralCOVID-19 VaccinesInfluenza VaccinesPneumococcal VaccinesVaccines, CombinedVaccines, Inactivated23-valent pneumococcal polysaccharide vaccineCoadministrationInactivated SARS-CoV-2 vaccineSplit-virion inactivated influenza vaccine

Identifiers

PMID35931636
PMCPMC9334936
OpenAlexW4288734775

What OpenQuestion holds

Textmetadata
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.