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Phase I Clinical Trial of PCV24 in People Aged 18 Years and Older

NCT06678607 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-11-07

No results posted yet for this study

Summary

Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older . The objective of the study is to evaluate the safety and tolerability of PCV24. The trial is a single-center, randomized, blind,parallel-controlled design I clinical trial.

Conditions

  • Pneumococcal Infectious Disease

Interventions

BIOLOGICAL

Reinovax PCV24 formulation 1

One dose of Reinovax PCV24 formulation 1（0.5mL）

BIOLOGICAL

Reinovax PCV24 formulation 2

One dose of Reinovax PCV24 formulation 1（0.5mL）

BIOLOGICAL

PPSV23

One dose of PPSV23 (0.5 mL) contains 1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F and33F saccharides.

BIOLOGICAL

Placebo

One dose of 0.5 mL placebo is aluminum phosphate adjuvant (aluminum content 0.25mg/dose), sodium chloride, succinic acid, polysorbate 80, and water for injection except for antigen components in 24-valent pneumococcal polysaccharide conjugate vaccine

Sponsors & Collaborators

  • Shanghai Reinovax Biologics Co.,LTD

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-19
Primary Completion
2024-07-28
Completion
2024-07-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06678607 on ClinicalTrials.gov