Evidence map›Paper›PMID 39693187›Full record

ArticleHuman vaccines & immunotherapeutics2024

Monitoring the safety of the adjuvanted human papillomavirus vaccine, HPV-16/18-AS04: Protocol for a cohort study using electronic health records in Yinzhou, China.

Junting Yang, Sarah Welby, Zhike Liu, Siwei Deng, Guangxu Liu, Ruogu Meng, Yu Yang, Yixin Sun, Yunkun He, Ning Jiang and 5 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Observational
  2. 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

15 authors.

Junting YangDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
Sarah WelbyGSK, Wavre, Belgium.
Zhike LiuDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
Siwei DengDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
Guangxu LiuDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
Ruogu MengNational Institute of Health Data Science, Peking University, Beijing, China.
Yu YangNational Institute of Health Data Science, Peking University, Beijing, China.
Yixin SunDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
Yunkun HeGSK, Shanghai, China.
Ning JiangGSK, Shanghai, China.
Zhenhua WuGSK, Shanghai, China.
Keruo LiuGSK, Shanghai, China.
Dominique RosillonGSK, Wavre, Belgium.
Catherine CohetGSK, Wavre, Belgium.
Siyan ZhanDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This protocol was developed to conduct population-wide surveillance of the bivalent HPV-16/18-AS04-adjuvanted human papillomavirus (HPV) vaccine in terms of uptake and safety outcomes including potential immune-mediated diseases (pIMDs) and pregnancy-related outcomes in China. The study will use electronic health records from 2010 to 2020 from the Yinzhou Regional Health Information Platform and include a population-based cohort of female permanent residents aged 9-45 years. Baseline and follow-up periods will be defined according to the 2017 introduction of HPV-16/18-AS04 in China. Patients with pIMDs and pregnancy-related outcomes will be identified using primary diagnostic codes from outpatient and inpatient electronic health records. A time trend analysis will be performed to describe the incidence of pIMDs and pregnancy-related outcomes during baseline and follow-up periods by age and overall, per calendar year. Depending on the number of safety outcomes and the size of the study population, incidence in vaccinated and unvaccinated cohorts will be compared using a Poisson regression model for pIMDs and a logistic regression model for pregnancy-related outcomes, adjusting for age and calendar year. Methods and findings from this study will provide valuable experience for designing future real-world studies and complement observations made during clinical trials and post-marketing studies.

Indexed as

Electronic Health RecordsHuman papillomavirus 18Papillomavirus InfectionsPapillomavirus VaccinesAdjuvants, ImmunologicAdolescentAdultChildChinaCohort StudiesFemaleHuman papillomavirus 16HumansIncidenceMiddle AgedPregnancyAdjuvants, ImmunologicPapillomavirus VaccinesHPV-16/18-AS04human papillomavirus vaccinepotential immune-mediated diseasespregnancy outcomessafety

Identifiers

PMID39693187
PMCPMC11487940

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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.