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Phase I/II Clinical Trial of 26-valent Pneumococcal Conjugate Vaccine

NCT06703203 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-03-30

No results posted yet for this study

Summary

The purpose of this experiment is to evaluate the safety and immunogenicity of the 26 valent pneumococcal conjugate vaccine in the population aged 2 months and above.

Conditions

  • Pneumococcal Vaccines

Interventions

BIOLOGICAL

26-Valent pneumococcal conjugate vaccine

As an experimental group. The active ingredient of 26-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 26 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time.

BIOLOGICAL

23-Valent pneumococcal polysaccharide vaccine

As a control group. The effective ingredients of 23-valent pneumococcal polysaccharide vaccine are 23 serotypes of pneumococcal capsular polysaccharides. Administer one dose of 0.5mL each time.

BIOLOGICAL

13-Valent pneumococcal conjugate vaccine

As a control group. The active ingredient of 13-valent pneumococcal conjugate vaccine is the capsular polysaccharide of 13 pneumococcal serotypes conjugated to the tetanus toxoid carrier protein. Administer one dose of 0.5mL each time.

Sponsors & Collaborators

  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-17
Primary Completion
2025-08-05
Completion
2026-02-05

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 NCT06703203 on ClinicalTrials.gov