Evaluating a new oral rotavirus vaccine in infants

Evaluating the Immunogenicity and Safety of the Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells) in Healthy Infants Via a Randomized, Double-blind, Active-controlled Phase II Clinical Trial.

This study is testing a new oral rotavirus vaccine in healthy infants aged 6 to 12 weeks to see if it is safe and effective at building immunity.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 6 Weeks to 12 Weeks
• Sex: All
• Sponsor: Sinovac Biotech Co., Ltd (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06967272 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial assesses the immunogenicity and safety of an oral hexavalent rotavirus vaccine in healthy infants aged 6 to 12 weeks. The study involves a randomized, double-blind, active-controlled design, comparing the investigational vaccine in both high-dose and low-dose formulations against a control vaccine. Participants will receive three doses of the vaccine at 28-day intervals, with blood samples collected to evaluate immune response and monitoring for adverse events over a 12-month period. Additionally, stool samples will be collected to study vaccine virus shedding and safety.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy infants aged 6 to 12 weeks.

Not a fit: Patients who have previously received any rotavirus vaccine or have a history of rotavirus infection will not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of rotavirus gastroenteritis in infants.

How similar studies have performed: Other studies have shown success with similar rotavirus vaccine approaches, indicating a promising avenue for immunization.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Previous vaccination with any rotavirus vaccine.
2. History of rotavirus infection.
3. Gestational age \<37 weeks or ≥42 weeks at birth.
4. History of dystocia, neonatal asphyxia requiring resuscitation, or neurological impairment at birth.
5. Known hypersensitivity to any vaccine component (e.g., urticaria, dyspnea, angioedema).
6. Current diarrhea, vomiting, or other gastrointestinal disorders; gastroenteritis or any acute/chronic illness exacerbation within 7 days prior to vaccination; ongoing antibiotic/antiviral therapy.
7. History of intussusception or chronic gastrointestinal diseases, including congenital malformations predisposing to intussusception (e.g., Meckel's diverticulum).
8. 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).
9. Autoimmune or immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection).
10. Household members with immunodeficiency/immunosuppression or undergoing/scheduled for immunosuppressive/cytotoxic therapy.
11. Coagulation disorders (e.g., clotting factor deficiencies, platelet abnormalities).
12. Immunosuppressive therapy for ≥14 days post-birth (prednisone ≥2mg/kg/day or equivalent), immunomodulatory/cytotoxic therapy, or planned use during the study.
13. History of severe neurological/psychiatric disorders (e.g., epilepsy, non-febrile seizures, convulsions) or relevant family history.
14. Postnatal administration of immunoglobulins/blood products (except hepatitis B immunoglobulin) or planned use during the study.
15. Previous participation in other investigational drug/vaccine studies or planned use during this study.
16. Receipt of live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment.
17. Axillary temperature ≥38.0°C within the past 3 days.
18. Fever on scheduled vaccination day (axillary temperature \>37.0°C; measured ≥30 minutes post-feeding).
19. Currently or planning to participate in other vaccine or drug clinical trials.
20. Any other factors that the investigator deems unsuitable for participation in the clinical trial.

Where this trial is running

Wuhan, Hubei

• Hubei Provincial Center for Disease Control and Prevention — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Yeqing Tong

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