Observational studyJournal of Korean medical science2019
A 6-year Prospective, Observational, Multi-Center Post-Marketing Surveillance of the Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine in Korea.
Observational study in Journal of Korean medical science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01929291 (Assessment of Safety of GlaxoSmithKline), which is not on this map. Cited by 7 papers.
What it found
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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.
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.
Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Reduced Antigen Content Diphtheria-tetanus Toxoids and Acellular Pertussis Vaccine (dTPa), Boostrix When Administered According to the Approved Prescribing Information in Korea
Who cites it
7 citing papers in PubMed, 10 citations in OpenAlex.
- Immunogenicity and Safety of a Newly Developed Tetanus-Diphtheria Toxoid (Td) in Healthy Korean Adolescents: a Multi-center, Randomized, Double-blind, Active-Controlled Phase 3 Trial.Journal of Korean medical science · 2021Trial
- Post-marketing safety surveillance of tetanus, diphtheria, and acellular pertussis (Tdap) vaccine: a disproportionality analysis of the vaccine adverse event reporting system (2015-2025).Frontiers in cellular and infection microbiology · 2026Article
- Safety Evaluation of Tetanus, Diphtheria, and Acellular Pertussis Vaccine (Tdap) During Pregnancy Among Vietnamese Women.Vaccines · 2025Article
- Real-world safety profile of the diphtheria, tetanus, and acellular pertussis combined vaccine: A study in Huzhou from 2020 to 2024.Medicine · 2025Observational
- Observational
- Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: nationwide cohort study.BMJ (Clinical research ed.) · 2021Article
- Travelers' vaccines and their adverse events in Nara, Japan.Open medicine (Warsaw, Poland) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIncidence of whooping cough is increasing in Korea. Since 2011, occurrence among adolescents and adults has risen putting vulnerable neonates at risk. National immunization guidelines now include Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis) vaccination during pregnancy and as a cocooning strategy (i.e., vaccinating adults and adolescents in contact with neonates). This study assessed post-marketing Tdap (Boostrix
methodsThis open, non-comparative multi-center study was conducted over six years at 10 hospitals in Korea. Subjects received Tdap in normal clinical practice according to local prescribing information. All adverse events (AEs) were recorded, classified as expected or unexpected, and severity and relationship to Tdap were assessed.
resultsThe analysis included 672 Korean subjects (mean age, 44 years; range, 11-81), 451 were women and 211 were pregnant. Ninety subjects experienced 124 AEs (incidence 13.39%) of which six were serious AEs (SAEs) assessed as not related to vaccination, and 51 were non-SAEs related to vaccination (mostly administration site reactions). Overall 65/124 AEs were unexpected; the most common were 14 constipation, 5 dyspepsia, 4 common cold and 4 premature labor cases. One case of common cold was assessed as possibly related to vaccination. Pregnancy outcome was 'live infant, no apparent congenital anomaly' in 195 subjects (92.42%) or 'lost to follow-up' in 16 subjects.
conclusionTdap administration to Korean subjects ≥ 10 years, including pregnant women, for the prevention of diphtheria, tetanus and pertussis was shown to have a well-tolerated safety profile.
trial registrationClinicalTrials.gov Identifier: NCT01929291.
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