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NOT YET RECRUITING
NCT06970756
PHASE1

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

Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-05-27

Completion Date

2026-07-10

Last Updated

2025-05-18

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Emeritus Research

Melbourne, Victoria, Australia