ArticleInfectious diseases and therapy2026
Post-marketing Safety Surveillance of 23-Valent Pneumococcal Polysaccharide Vaccine Administered Alone and Concomitantly with Influenza Vaccine in Individuals Aged 2 Years and Older in China.
Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07071701 (A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population Aged 2 Years and Above), which is not on this map. Not yet cited in PubMed.
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A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population Aged 2 Years and Above
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11 authors.
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Abstract
introductionThis phase IV study aimed to evaluate the safety of the 23-valent pneumococcal polysaccharide vaccine (PPV23) in individuals aged 2 years and older through active and passive surveillance.
methodsSafety data were collected from May 2022 to March 2024 through 28-day post-vaccination active surveillance via active follow-up and 1-year passive surveillance via the Chinese National Adverse Events Following Immunization (AEFI) Information System (CNAEFIS). Adverse drug reactions (ADRs) via active follow-up and AEFIs via CNAEFIS were analyzed by age, health status, and co-administration status.
resultsA total of 19,267 participants received a single dose of PPV23, including 2977 under active surveillance and 16,290 under passive surveillance. In active surveillance, the overall incidence of ADRs was 1.81%, mostly mild and self-limiting, with rates of 1.76% in children (2-17 years), 2.28% in adults (18-59 years), and 1.67% in older adults (60 years and older). The incidence was 1.79% among healthy participants and 1.92% among participants with underlying medical conditions, and the incidence was 1.01% following PPV23 alone and 4.96% after co-administration with influenza vaccines. Passive surveillance identified 60 AEFI case reports (368 per 100000 doses), all occurring within 7 days of vaccination. No serious adverse event or serious AEFI were reported.
conclusionThe PPV23 showed a favorable safety profile in all age groups, regardless of health status or co-administration with influenza vaccines. These findings support the use of PPV23 and provide evidence for its co-administration with influenza vaccines. CLINICALTRIALS: GOV IDENTIFIER: NCT07071701. Retrospectively registered.
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