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Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above

NCT06642558 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 522

Last updated 2025-06-06

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and immunogenicity of two dose levels of the single dose Recombinant RSV vaccine(CHO cells), when administered intramuscularly (IM) in healthy adults aged 18 years and older.

Conditions

  • Respiratory Syncytial Virus (RSV)

Interventions

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose)

0.25 mL per dose.

BIOLOGICAL

Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose)

0.5 mL per dose

BIOLOGICAL

Placebo (Saline solution)

0.5 mL per dose

Sponsors & Collaborators

  • Henan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • MAXVAX Biotechnology Limited Liability Company

    lead INDUSTRY

Principal Investigators

  • Lili Huang · Henan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2025-06-30
Completion
2027-02-28

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 NCT06642558 on ClinicalTrials.gov