Lack of association between febrile seizures and vaccines containing diphtheria, tetanus, and acellular pertussis in Chinese children

ABSTRACT

Background

The association between the administration of vaccines containing diphtheria, tetanus, and acellular pertussis (DTaP) and febrile seizures (FSs) is unclear. This study aimed to evaluate the risk of FSs after the administration of DTaP-containing vaccines in Chinese children aged 1 to 23 months.

Research design and methods

A self-controlled case series (SCCS) design was adopted based on data from the Ningbo Regional Health Information Platform (NRHIP). The observation period was from 1 to 23 months of age. The relative incidences (RIs) within 0 to 3 days, 4 to 7 days, and 0 to 7 days after the administration of DTaP-containing vaccines were estimated. The remaining observation period was the control period.

Results

The RIs within 0 to 3 days, 4 to 7 days, and 0 to 7 days after any dose of DTaP-containing vaccines were 1.14 (95% CI 0.86 to 1.52), 0.89 (95% CI 0.65 to 1.23), and 1.02 (95% CI 0.82 to 1.26), respectively.

Conclusions

This study provides reassuring evidence that there is no increased risk of FSs immediately after the administration of DTaP-containing vaccines, which might serve to reassure both professionals and families with regard to the risk of FSs associated with DTaP-containing vaccines.

KEYWORDS:

• Diphtheria, tetanus, and acellular pertussis vaccine
• febrile seizure
• relative incidence
• self-controlled case series study

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Conceptualization, L Xu, Z Liu and S Zhan; Methodology, L Xu, Z Liu and S Zhan; Software, L Xu; Validation, L Xu and Z Liu; Formal Analysis, L Xu; Investigation, L Xu, N Li, L Zhang, R Ma, T Fang and Z Liu; Resources, N Li and L Zhang; Data Curation, N Li and L Zhang; Writing – Original Draft Preparation, L Xu; Writing – Review & Editing, all authors; Visualization, L Xu; Supervision, Z Liu and S Zhan; Project Administration, Z Liu and S Zhan; Funding Acquisition, L Xu and S Zhan. All authors agreed the final version of the manuscript and agreed to be accountable for all aspects of the work.

Data availability statement

Due to the Ningbo government’s restrictions, deidentified individual participant data will not be made available.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This work was supported by the China Postdoctoral Science Foundation [grant number 2022TQ0014] to L Xu, the National Natural Science Foundation of China [grant number 91846303] to S Zhan, and Special Project for Director, China Center for Evidence Based Traditional Chinese Medicine [grant number 2020YJSZX-2] to S Zhan.