Evidence map›Paper›PMID 37283972›Full record

ArticleThe Lancet regional health. Western Pacific2023

Immuno-persistence of the different primary polio vaccine schedules and immunogenicity of the booster dose by sabin inactivated or bivalent oral poliovirus vaccine in children aged 4 years: an open-label, randomised, controlled phase 4 trial in China.

Xuewen Tang, Yanhui Xiao, Xuan Deng, Yang Zhou, Haiping Chen, Rui Yan, Yao Zhu, Shengyi Wang, Hui Wang, Xiujuan Zhu and 8 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet regional health. Western Pacific, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04576910 (Immunogenicity and Safety of the Booster Dose of Polio Vaccine Immunization Using Sabin IPV or bOPV at Children Aged 4 Years With Different Three Sequential Schedules History by Sabin IPV or bOPV in China), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04576910 phase4completednot on this map

Immunogenicity and Safety of the Booster Dose of Polio Vaccine Immunization Using Sabin IPV or bOPV at Children Aged 4 Years With Different Three Sequential Schedules History by Sabin IPV or bOPV in China

TypeinterventionalSponsorZhejiang Provincial Center for Disease Control and PreventionRan2020 to 2021Enrolled387ConditionsPolio, Vaccine ReactionArmsvaccinated with Sabin IPV, vaccinated with bOPV
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

18 authors.

Xuewen TangZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Yanhui XiaoChina National Biotec Group Company Limited, Beijing, China.
Xuan DengZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Yang ZhouZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Haiping ChenChina National Biotec Group Company Limited, Beijing, China.
Rui YanZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Yao ZhuZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Shengyi WangChina National Biotec Group Company Limited, Beijing, China.
Hui WangBeijing Institute of Biological Products Company Limited, Beijing, China.
Xiujuan ZhuBeijing Institute of Biological Products Company Limited, Beijing, China.
Linyun LuoChina National Biotec Group Company Limited, Beijing, China.
Yan LiuHangzhou Municipal Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Zhiying YinQuzhou Municipal Center for Disease Control and Prevention, Quzhou, Zhejiang, China.
Guoping ZhangChun'an County Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Zhongbing ChenLongyou County Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Jian JiangChun'an County Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.
Xiaoming YangChina National Biotec Group Company Limited, Beijing, China.
Hanqing HeZhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Sabin inactivated and bivalent oral poliovirus vaccine (sIPV, bOPV) were commonly used in China since 2016. We conducted an open-label, randomised, controlled phase 4 trial to assess immune persistence following sequential immunisation with sIPV or bOPV, and immunogenicity and safety of a booster dose of poliovirus vaccine in children aged 4 years. Methods: Participants from a previous clinical trial with three different sequential schedules with sIPV (I) or bOPV (B) at ages 2, 3, and 4 months (Groups I-B-B, I-I-B, I-I-I) in 2017 were followed-up. The children were further divided into five subgroups after sIPV was given for Group I-B-B, and sIPV or bOPV randomly given for Group I-I-B and Group I-I-I (128 children in Groups I-B-B-I, 60 in Group I-I-B-B, 64 in Group I-I-B-I, 68 in Group I-I-I-B, 67 in Group I-I-I-I). Immune persistence and immunogenicity were assessed by measuring poliovirus type-specific antibodies, and safety were analysed in all children who received the booster dose. Findings: Between Dec 5, 2020 and Jun 30, 2021, we respectively enrolled 381 participants in the immune persistence analysis, and 352 participants in per protocol (PP) analysis of the immunogenicity of the booster immunisation. Seropositivity rates of antibodies against poliovirus types 1 and 3 were all >90% four years after primary immunisation, while for poliovirus type 2 were 46.83%, 75.41%, and 90.23% (χ Interpretation: Our findings suggest that at least two sIPV doses are needed in the current routine poliovirus immunisation schedule, and schedules containing 3 or 4 doses of sIPV provide better protection against poliovirus type 2 than the current sIPV-sIPV-bOPV-bOPV schedule in China. Funding: Medical and Health Science and Technology of Zhejiang Province (2021KY118). This trial was registered with ClinicalTrials.gov (NCT04576910).

Indexed as

Booster doseImmunogenicityPersistence immunityPoliovirusSabin strain

Identifiers

PMID37283972
PMCPMC10240380

What OpenQuestion holds

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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.