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Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old

NCT06350058 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2024-04-05

No results posted yet for this study

Summary

The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

Inactivated rotavirus vaccine (low dose)

The protein content of each dose is 2.5 μg. The antigen content shall not be less than 2000U, and each person shall receive one dose of 0.5ml.

BIOLOGICAL

Inactivated rotavirus vaccine (high dose)

The protein content of each dose is 5 μg. The antigen content shall not be less than 4000U, and each person shall receive one dose of 0.5ml.

BIOLOGICAL

Placebo

Aluminum hydroxide adjuvant.

Sponsors & Collaborators

  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lin Du · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2023-11-30
Completion
2024-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06350058 on ClinicalTrials.gov