Clinical Trial

A Phase I Clinical Study to Evaluate the Safety of PCV26 in Individuals ≥60

Not Yet Recruiting Phase 1
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Record status
This record was last updated May 18, 2025 (before its estimated November 27, 2025 completion). Its status may not reflect the trial's current state.
Summary
This Phase I, randomized, double-blind, parallel-controlled study is to be conducted in healthy adults aged 60 and above. Participants will be randomly assigned in a 1:1 ratio to receive either 26-valent Pneumococcal Conjugate Vaccine (PCV26) or the comparator (PCV13) on Day 1 (Visit 1). Solicited adverse events (AEs) will be collected for 7 days post-vaccination and unsolicited AEs for 28 days post-vaccination, with safety data limited to serious adverse events (SAEs), and newly diagnosed chronic medical conditions (NDCMCs) collected up to 6 months post-vaccination.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-06.
Trial Details
NCT Number NCT06970756
Lead Sponsor Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Conditions Pneumococcal Diseases
Enrollment 60 participants
Start Date 2025-05-27
Primary Completion 2025-11-27 (estimated)
Study Completion 2026-07-10 (estimated)
Updated on ClinicalTrials.gov 2025-05-18