MedTrace Logo

Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects

NCT05805618 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-28

No results posted yet for this study

Summary

To evaluate the safety and immunogenicity of different dose levels of the Recombinant Norovirus Hexavalent Vaccine in healthy subjects aged 18-59 years given three doses of the vaccine at 28-day intervals.

Conditions

Interventions

BIOLOGICAL

Recombinant Norovirus Hexavalent Vaccine

To prevent acute gastroenteritis caused by norovirus of genotypes GI.1, GII.2, GII.3, GII.4, GII.6, and GII.17

OTHER

Matching Placebo

matching placebo for Recombinant Norovirus Hexavalent Vaccine / KH002

Sponsors & Collaborators

  • Chengdu Kanghua Biological Products Co., Ltd

    collaborator INDUSTRY

  • Syneos Health

    lead OTHER

Principal Investigators

  • Kristi McLendon, Dr · Q-Pharm Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-11-01
Completion
2024-11-01

More Related Trials

Entities

Diseases
Companies

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 NCT05805618 on ClinicalTrials.gov