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Phase I Clinical Trial of a Candidate PCV13 in Healthy People

NCT05602480 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2022-11-17

No results posted yet for this study

Summary

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.

This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

0.5mL, Intramuscular

BIOLOGICAL

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

0.5mL, Intramuscular

Sponsors & Collaborators

  • Hunan Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Liaoning Chengda Biotechnology CO., LTD

    collaborator INDUSTRY

  • Wuhan BravoVax Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-06-30
Completion
2024-12-31

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 NCT05602480 on ClinicalTrials.gov