MedTrace Logo

PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)

NCT06967272 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-08-22

No results posted yet for this study

Summary

The Phase II clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in infants aged 6 to 12 weeks. This study will evaluate the immunogenicity and safety of the investigational vaccine in healthy infants through a randomized, double-blind, active-controlled trial.

Conditions

  • Rotavirus Gastroenteritis

Interventions

BIOLOGICAL

Oral hexavalent reassortant rotavirus attenuated live vaccine

Oral hexavalent reassortant rotavirus attenuated live vaccine (low-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 pentavalent reassortant rotavirus attenuated live vaccine (controlled)

The controlled vaccine three doses administered orally

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2026-06-15
Completion
2026-11-15

Countries

  • China

Study Locations

More Related Trials

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 NCT06967272 on ClinicalTrials.gov