MedTrace Logo

Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine

NCT04087460 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-11-04

No results posted yet for this study

Summary

Infections with Streptococcus pneumoniae often cause serious health problems, especially for infants and the elderly.Failure to cover all polysaccharide types is an even greater problem with adults than with children.

The aim of the study is to preliminary evaluate the safety and immunogenicity of PBPV vaccine compared to placebo,in order to provide a basis for subsequent clinical trial design.

Conditions

  • Pneumonia
  • Respiratory Tract Diseases
  • Respiratory Tract Infections

Interventions

BIOLOGICAL

Protein based pneumococcal vaccine(Low dose)

0.2mL,Intramuscular other name:PBPV

BIOLOGICAL

Protein based pneumococcal vaccine placebo(Low dose)

0.2mL,Intramuscular other name:PBPV placebo

BIOLOGICAL

Protein based pneumococcal vaccine(Middle dose)

0.5mL,Intramuscular other name:PBPV

BIOLOGICAL

Protein based pneumococcal vaccine placebo(Middle dose)

0.5mL,Intramuscular other name:PBPV placebo

BIOLOGICAL

Protein based pneumococcal vaccine(High dose)

1.0mL,Intramuscular other name:PBPV

BIOLOGICAL

Protein based pneumococcal vaccine placebo(High dose)

1.0mL,Intramuscular other name:PBPV placebo

Sponsors & Collaborators

  • Henan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Xia Shengli · Henan Province Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-10
Primary Completion
2021-05-30
Completion
2022-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04087460 on ClinicalTrials.gov