Adverse reaction surveillance analysis of domestic human papillomavirus vaccines with different production processes
10.3760/cma.j.cn112150-20250425-00355
- VernacularTitle:不同生产工艺国产人乳头瘤病毒疫苗不良反应监测分析
- Author:
Haibo WANG
1
;
Yu LIU
;
Shuchan CHENG
;
Wenfei TAO
;
Chunfang HU
;
Lifang ZHOU
;
Bangjun LYU
;
Min XU
;
Jieqiong HUANG
Author Information
1. 柳州市疾病预防控制中心，柳州 545007
- Publication Type:Journal Article
- Keywords:
Different manufacturing processes;
Human papilloma virus vaccines;
Adverse reactions;
Comparison of safety;
Comparison of vaccination compliance
- From:
Chinese Journal of Preventive Medicine
2025;59(11):1952-1957
- CountryChina
- Language:Chinese
-
Abstract:
This study aims to compare the vaccination rates and incidence of adverse reaction rates following administration of two domestically produced human papillomavirus (HPV) vaccines in individuals aged 9-30 years,investigate the impact of distinct manufacturing processes and vaccination schedules on adverse reaction rates. From November 2023 to June 2024, the Immunization Planning Department of Liuzhou Center for Disease Control and Prevention conducted a single-center, randomized, open-label, parallel-group trial using community-based recruitment of eligible participants aged 9 to 30 years. Participants were randomly assigned to receive either of two domestically produced HPV vaccines (Walrinvax or Cecolin). As specified in the vaccine package inserts, subjects were stratified into a two-dose regimen group (aged 9-14 years) and a three-dose regimen group (aged 15-30 years). Vaccination rates were recorded, and adverse reactions within 0-30 days post-vaccination were monitored. The results showed that a total of 400 participants were enrolled. Both the full vaccination rate and the timely completion rate were significantly higher in the two-dose regimen group compared to the three-dose regimen group (Fisher′s exact test, P<0.01; χ2=7.06, P<0.01). A total of 985 doses were administered. The overall adverse reaction rate was 18.78% (185/985), with local and systemic reactions occurring at 8.02% (79/985) and 10.76% (106/985), respectively. The most frequent adverse reactions were injection site pain (4.97%, 49/985) and fever (4.47%, 44/985). No grade 4 or special-interest adverse events were reported.The incidence of adverse reactions for the two domestic HPV vaccines with different production processes (at 0/6 months) was 13.96% (55/394) and 17.46% (69/395) respectively, with no statistically significant difference (χ2=1.83, P>0.05).The adverse reaction rate was significantly lower in the 9-14 years group (9.77%) compared the 15-30 years group (24.91%)(χ 2=35.67, P<0.01). In conclusion, both domestic HPV vaccines demonstrated a favorable safety profile in the 9-30 years age group, with mostly mild adverse reactions. Compared to the three-dose schedule (15-30 years group), the two-dose HPV vaccination schedule (9-14 years group) significantly reduced the incidence of adverse reactions and improved vaccination compliance.
