Evidence map›Paper›PMID 31660344›Full record

ArticleOpen forum infectious diseases2019

Safety and Immunogenicity of Sabin Strain Inactivated Poliovirus Vaccine Compared With Salk Strain Inactivated Poliovirus Vaccine, in Different Sequential Schedules With Bivalent Oral Poliovirus Vaccine: Randomized Controlled Noninferiority Clinical Trials in China.

Yuemei Hu, Kangwei Xu, Weixiao Han, Kai Chu, Deyu Jiang, Jianfeng Wang, Xiaohui Tian, Zhifang Ying, Ying Zhang, Changgui Li and 1 more

Abstract read
In one paragraph

Article in Open forum infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

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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

11 authors.

Yuemei HuDepartment of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Kangwei XuDepartment of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Weixiao HanDepartment of Clinical Research, Sinovac Biotech Co., Ltd., Beijing, China.
Kai ChuDepartment of Vaccine Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Deyu JiangCenter of Research & Development, Sinovac Biotech Co., Ltd., Beijing, China.
Jianfeng WangDivision of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Beijing, China.
Xiaohui TianDepartment of Clinical Research, Sinovac Biotech Co., Ltd., Beijing, China.
Zhifang YingDivision of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Beijing, China.
Ying ZhangProject Management Center, Sinovac Biotech Co., Ltd., Beijing, China.
Changgui LiDivision of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Beijing, China.
Fengcai ZhuJiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA new Sabin strain inactivated poliovirus vaccine (sIPV) proved to be immunogenic and safe in all IPV primary immunization in the previous study, with the corresponding profiles in sequential immunizations unclear.

methodsTwo clinical trials on the "IPV + 2 bivalent oral polio vaccine (2bOPV)" (Trial A) and "2IPV + bOPV" (Trial B) vaccination were conducted. Both clinical trials were randomized, controlled, double-blinded, noninferiority trials, and wild-strain IPV (wIPV) was adopted as the control vaccine. In each clinical trial, 240 healthy infants were enrolled and randomly assigned to receive sequential vaccinations containing sIPV or wIPV. Immunogenicity and safety were assessed using per-protocol and safety populations, respectively.

resultsFor Trial A, the seroconversion rates in the experimental and control groups were 100% and 99.1%, respectively, against type 1; both 100.0% against type 3. For Trial B, the seroconversion rates in experimental and control groups were 99.2% and 100.0%, respectively, against type 1; both 100% against type 3. No serious adverse events related to vaccines were reported.

conclusionsThe new sIPV demonstrated an immunogenicity noninferior to that of the wIPV and a good safety profile in sequential vaccination with bOPV. CLINICAL TRIAL NUMBERS: NCT:03822754; NCT:03822767.

Indexed as

inactivated vaccinenoninferiority clinical trialpoliovirusSabin strainsequential vaccination

Identifiers

PMID31660344
PMCPMC6786509

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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.