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

NCT06967272 | Recruiting Phase 2

• 1 other identifier: PRO-RV-2001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Phase II; Immunogenicity; Safety; Randomized Controlled Trial; Rotavirus gastroenteritis; Vaccine

Outcome Measures

Primary Outcomes (2)

• Evaluate the immunogenicity of the investigational vaccine at different doses

  The seroconversion rate of IgA antibodies against vaccine-type rotavirus in serum

  28 days after the full vaccination course

• Evaluate the safety of the investigational vaccine at different dose

  Incidence of adverse events/reactions

  0 day after the first dose till 42 days after the last dose

Secondary Outcomes (11)

• Evaluate the immunogenicity of the investigational vaccine at different doses

  28 days after the full vaccination course

• Evaluate the immunogenicity of the investigational vaccine at different doses

  28 days after the full vaccination course

• Evaluate the immunogenicity of the investigational vaccine at different doses

  28 days after the full vaccination course

• Evaluate the immunogenicity persistence of the investigational vaccine at different doses

  12 months after the full vaccination course

• Evaluate the immunogenicity persistence of the investigational vaccine at different doses

  12 months after the full vaccination course

Study Arms (3)

Low dose

EXPERIMENTAL

The experimental vaccine will be administered in three doses, with a 28-day interval between each dose.

Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine

High dose

EXPERIMENTAL

The experimental vaccine will be administered in three doses, with a 28-day interval between each dose.

Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine

Control

ACTIVE COMPARATOR

The controlled vaccine will be administered in three doses, with a 28-day interval between each dose.

Biological: Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled)

Interventions

Oral hexavalent reassortant rotavirus attenuated live vaccine BIOLOGICAL

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

Low dose

Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled) BIOLOGICAL

The controlled vaccine three doses administered orally

Control

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants aged 6 to 12 weeks.
• The legal guardian(s) is/are capable of understanding and voluntarily signing the informed consent form.
• The legal guardian(s) is/are willing and able to comply with all follow-up visits, sample collection, vaccination, and other study procedures.
• Able to provide valid legal identification documents.

You may not qualify if:

• Previous vaccination with any rotavirus vaccine.
• History of rotavirus infection.
• Gestational age \<37 weeks or ≥42 weeks at birth.
• History of dystocia, neonatal asphyxia requiring resuscitation, or neurological impairment at birth.
• Known hypersensitivity to any vaccine component (e.g., urticaria, dyspnea, angioedema).
• Current diarrhea, vomiting, or other gastrointestinal disorders; gastroenteritis or any acute/chronic illness exacerbation within 7 days prior to vaccination; ongoing antibiotic/antiviral therapy.
• History of intussusception or chronic gastrointestinal diseases, including congenital malformations predisposing to intussusception (e.g., Meckel's diverticulum).
• Congenital malformations, developmental disorders, genetic defects, severe malnutrition, malignancies, or significant chronic conditions (e.g., Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome).
• Autoimmune or immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection).
• Household members with immunodeficiency/immunosuppression or undergoing/scheduled for immunosuppressive/cytotoxic therapy.
• Coagulation disorders (e.g., clotting factor deficiencies, platelet abnormalities).
• Immunosuppressive therapy for ≥14 days post-birth (prednisone ≥2mg/kg/day or equivalent), immunomodulatory/cytotoxic therapy, or planned use during the study.
• History of severe neurological/psychiatric disorders (e.g., epilepsy, non-febrile seizures, convulsions) or relevant family history.
• Postnatal administration of immunoglobulins/blood products (except hepatitis B immunoglobulin) or planned use during the study.
• Previous participation in other investigational drug/vaccine studies or planned use during this study.

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, 430079, China

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Yeqing Tong

CONTACT

+86-13971078410; 63382251@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: May 13, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

CN (1)