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

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Notable Primary endpoints revised (2)
    • Study title shortened, about 7 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06970756
Lead Sponsor Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Conditions
(from sponsor)
Pneumococcal Diseases
Related terms Pneumococcal Infections
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov