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Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

NCT05092386 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2026-01-28

No results posted yet for this study

Summary

This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to preliminary evaluate the safety and immunogenicity of the study vaccine

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

The investigational vaccine was manufactured by Sinovac Research \& Development Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and diphtheria CRM197 in 0·5 mL of aluminum phosphate ,sodium chloride,polysorbate 80 and succinic acid per injection.

BIOLOGICAL

Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13)

The control vaccine was manufactured by WALVAX Biotechnology Co., Ltd. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,disodium hydrogen phosphate and sodium dihydrogen phosphate per injection.

BIOLOGICAL

Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)

The control vaccine was manufactured by Pfizer. each for purified 13 serotypes of pneumococcal polysaccharide and tetanus toxoid vector (TT) in 0·5 mL of aluminum phosphate ,sodium chloride ,succinic acid ,polysorbate 80 and water for injection per injection.

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yanxia Wang, Master · Henan Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2024-05-26
Completion
2024-05-28

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 NCT05092386 on ClinicalTrials.gov