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Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine

NCT05731115 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2023-09-18

No results posted yet for this study

Summary

This study is a randomized, double-blind phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the consistency of three consecutive lots, immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine of commercial scale in participants aged 40-65 years.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

Experimental 23-valent Pneumococcal

The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B,17F,18C, 19A, 19F, 20, 22F, 23F, and 33F in 0.5 mL of sodium chloride mixture per injection.

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yunong Zhang · Shanxi Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-27
Primary Completion
2023-05-05
Completion
2023-05-05

Countries

  • China

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 NCT05731115 on ClinicalTrials.gov