Influenza vaccination rates remain low among primary school students and vary by school in Beijing, China. Theory-informed, multifaceted strategies are needed to improve influenza vaccination uptake. To evaluate the effectiveness of multifaceted strategies in improving influenza vaccination uptake among primary school students. This cluster randomized trial was conducted from September 2022 to May 2023 across primary schools in Beijing, China. Schools were allocated randomly in a 1:1 ratio to multifaceted strategies or usual practice. Schools were deemed eligible if the vaccination rates in the 2019 to 2020 season fell at or below the district-wide average for primary schools. Eligible participants included students in grades 2 and 3 with no medical contraindications for influenza vaccination. The multifaceted strategies intervention involved system-level planning and coordination (eg, developing an implementation blueprint, building social norms, and enhancing supervision), school-level training and educating school implementers (eg, conducting a 1-hour training and developing educational materials), and individual-level educating and reminding students and parents (eg, conducting educational activities and sending 4 reminders about vaccination). The primary outcomes were influenza vaccination uptake at school reported by school clinicians as well as overall vaccine uptake either at school or outside of school as reported by parents at 3 months. Generalized linear mixed models were used for analysis. A total of 20 schools were randomized. One intervention school and 2 control schools did not administer vaccination on school grounds due to COVID-19, resulting in a total of 17 schools (9 intervention and 8 control). There was a total of 1691 students aged 7 to 8 years (890 male [52.6%]; 801 female [47.4%]) including 915 in the intervention group and 776 in the control group. Of all participants, 848 (50.1%) were in grade 2, and 1209 (71.5%) were vaccinated in the 2021 to 2022 season. Participants in the intervention and control groups shared similar characteristics. At follow-up, of the 915 students in the intervention group, 679 (74.5%) received a vaccination at school, and of the 776 students in the control group, 556 (71.7%) received a vaccination at school. The overall vaccination rates were 76.0% (695 of 915 students) for the intervention group and 71.3% (553 of 776 students) for the control group. Compared with the control group, there was significant improvement of vaccination uptake at school (odds ratio, 1.40; 95% CI, 1.06-1.85; P = .02) and overall uptake (odds ratio, 1.49; 95% CI, 1.12-1.99; P = .01) for the intervention group. In this study, multifaceted strategies showed modest effectiveness in improving influenza vaccination uptake among primary school students, which provides a basis for the implementation of school-located vaccination programs of other vaccines in China, and in other countries with comparable programs. Chinese Clinical Trial Registry: ChiCTR2200062449.
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