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<p>In recent years, China has experienced a rapid increase in the number of pertussis cases among children aged 5 to 9. We conducted this phase 4 randomized, controlled trial (NCT05870631) in Zhejiang Province, China, to compare the immunogenicity and safety of co-purified diphtheria, tetanus, and acellular pertussis combined vaccine (co-purified DTaP) to diphtheria and tetanus combined vaccine (DT) in 6-year-old children. Between April 2023 to July 2023, 480 participants were randomized to receive one dose of co-purified DTaP (<i>n</i> = 240) or DT (<i>n</i> = 240). 28 days after vaccination, the seroconversion rates of the co-purified DTaP were 81.20% for anti-PT and 74.36% for anti-FHA, and achieved a significantly higher rate for anti-tetanus compared to the DT vaccine (97.01% vs. 87.05%, <i>P</i> &lt; 0.001). Both vaccines showed 100% seroconversion for anti- diphtheria antibody. For all antibody types, the co-purified DTaP can induced higher geometric mean concentrations. More vaccine-related adverse events were reported with the co-purified DTaP. Most of the severity occurred in Grade 1 and 2. The booster dose of co-purified DTaP vaccination is safe and induces a significant anti-pertussis antibody response, it may be feasible to give a booster dose of co-purified DTaP instead of the recommended DT for 6-year-old children in China.</p>

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Immunogenicity and safety of co-purified diphtheria, tetanus and acellular pertussis vaccine in 6-year-old Chinese children

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月29日

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  • Xuewen Tang,
  • Yanhui Xiao,
  • Jinhua Chen,
  • Ying Su,
  • Yang Zhou,
  • Linyun Luo,
  • Jiayou Zhang,
  • Shaoxiang Liu,
  • Rui Yan,
  • Dewu Zhu,
  • Wei Zhao,
  • Yao Zhu,
  • Xiao Ma,
  • Yuli Jiang,
  • Hailong Pan,
  • Yuntao Zhang,
  • Hanqing He

摘要

In recent years, China has experienced a rapid increase in the number of pertussis cases among children aged 5 to 9. We conducted this phase 4 randomized, controlled trial (NCT05870631) in Zhejiang Province, China, to compare the immunogenicity and safety of co-purified diphtheria, tetanus, and acellular pertussis combined vaccine (co-purified DTaP) to diphtheria and tetanus combined vaccine (DT) in 6-year-old children. Between April 2023 to July 2023, 480 participants were randomized to receive one dose of co-purified DTaP (n = 240) or DT (n = 240). 28 days after vaccination, the seroconversion rates of the co-purified DTaP were 81.20% for anti-PT and 74.36% for anti-FHA, and achieved a significantly higher rate for anti-tetanus compared to the DT vaccine (97.01% vs. 87.05%, P < 0.001). Both vaccines showed 100% seroconversion for anti- diphtheria antibody. For all antibody types, the co-purified DTaP can induced higher geometric mean concentrations. More vaccine-related adverse events were reported with the co-purified DTaP. Most of the severity occurred in Grade 1 and 2. The booster dose of co-purified DTaP vaccination is safe and induces a significant anti-pertussis antibody response, it may be feasible to give a booster dose of co-purified DTaP instead of the recommended DT for 6-year-old children in China.