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Research design for evaluating long-term vaccine effectiveness based on extended test-negative design under fixed study duration model
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Ting SHU1, 2, Xiang-yan ZENG2, Jun-ling FENG1, Ling WANG1, 3
Modern Preventive Medicine | 2025, 52(5) : 931 - 937
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Modern Preventive Medicine | 2025, 52(5): 931-937
Disease Control and Prevention
Research design for evaluating long-term vaccine effectiveness based on extended test-negative design under fixed study duration model
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Ting SHU1, 2, Xiang-yan ZENG2, Jun-ling FENG1, Ling WANG1, 3
Affiliations
  • Department of Health Statistics, Military Preventive Medicine, Air Force Medical University, Xi’an, Shaanxi 710032, China
Published: 2025-03-10 doi: 10.20043/j.cnki.MPM.202411070
Outline
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Objective

To explore a suitable research design for evaluating the long-term effects of vaccines, taking into account the heterogeneity caused by individual susceptibility, vaccination status, vaccination timing, and the confounding effects of healthcare-seeking behavior.

Methods

This study employed a Monte Carlo simulation method to extend the Test-Negative Design (TND),considering constant vaccine efficacy and two types of time-dependent vaccine efficacy under a fixed study duration model. A multivariable logistic regression model and a semi-parametric generalized additive model based on restricted cubic splines were constructed to evaluate the long-term effects of vaccines.

Results

When only considering changes in vaccine efficacy, the estimated vaccine effectiveness (VE) curves from both models accurately fit the actual decay trend of VE, being only slightly higher than the true VE (approximately 1%-3%). The VE curves were minimally affected by vaccination rates, the mean probability of influenza-like illness in the entire population, and the probability of influenza-like illness in the vaccinated population.

Conclusion

The extended TND under a fixed study duration model provides a feasible new approach for evaluating long-term vaccine effectiveness, with the potential for application to other types of vaccines. Both models demonstrated good fitting performance over time with no significant differences. However, further exploration is needed to comprehensively consider other heterogeneous influencing factors and to conduct simulation experiments with the extended TND after group assignment.

Extended TND  /  Restricted cubic splines  /  Time-dependency  /  Long-term vaccine effectiveness
Ting SHU, Xiang-yan ZENG, Jun-ling FENG, Ling WANG. Research design for evaluating long-term vaccine effectiveness based on extended test-negative design under fixed study duration model[J]. Modern Preventive Medicine, 2025 , 52 (5) : 931 -937 . DOI: 10.20043/j.cnki.MPM.202411070
Year 2025 volume 52 Issue 5
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Article Info
doi: 10.20043/j.cnki.MPM.202411070
  • Receive Date:2024-11-07
  • Online Date:2026-03-18
  • Published:2025-03-10
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  • Received:2024-11-07
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    Department of Health Statistics, Military Preventive Medicine, Air Force Medical University, Xi’an, Shaanxi 710032, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
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Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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