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The Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)

NCT06950645 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-20

No results posted yet for this study

Summary

The Phase I clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in a population ranging from 6 weeks to 59 years of age.

The objective of this study is to evaluate the safety of investigational vaccine in healthy adults and children, as well as its safety tolerability, and immunogenicity in healthy infants.

The study will be an open-label observation in adults and children, and a randomized, double-blind, placebo-controlled clinical trial in infants.

Conditions

  • Rotavirus Gastroenteritis

Interventions

BIOLOGICAL

Oral hexavalent reassortant rotavirus attenuated live vaccine

Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally

BIOLOGICAL

Oral hexavalent reassortant rotavirus attenuated live vaccine

Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally

BIOLOGICAL

Oral hexavalent reassortant rotavirus attenuated live vaccine

Oral hexavalent reassortant rotavirus attenuated live vaccine (low-dose) three doses administered orally

BIOLOGICAL

Placebo

Placebo of experimental vaccine for infants three doses administered orally

BIOLOGICAL

Oral hexavalent reassortant rotavirus attenuated live vaccine

Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally

BIOLOGICAL

Placebo

Placebo of experimental vaccine for infants three doses administered orally

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2024-12-21
Completion
2025-12-18

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 NCT06950645 on ClinicalTrials.gov