NCT06970756

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

A Phase I, Randomized, Double-blind, Parallel-controlled Clinical Study to Evaluate the Safety of a 26-valent Pneumococcal Conjugate Vaccine in Individuals Aged 60 and Above

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Diseases

Interventions

Type	Name	Description
BIOLOGICAL	26-valent Pneumococcal Conjugate Vaccine	Subjects were treated with a single intramuscular injection of 26-valent Pneumococcal Conjugate Vaccine.
BIOLOGICAL	13-valent Pneumococcal Conjugate Vaccine	Subjects were treated with a single intramuscular injection of 13-valent Pneumococcal Conjugate Vaccine.

Timeline

• Start date: 2025-05-27
• Primary completion: 2025-11-27
• Completion: 2026-07-10
• First posted: 2025-05-14
• Last updated: 2025-05-18

Locations

1 site across 1 country: Australia