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

NCT06970756 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lin Du · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-27
Primary Completion
2025-11-27
Completion
2026-07-10

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970756 on ClinicalTrials.gov