> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phaseiiclinical-trial-of-oral-hexavalent-reassortant-c85d64bf-fa47-4136-9b18-0c7230b8bf35 > Record changed: 2026-11-04 # PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells) NCT06967272 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) Participants 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) Lead sponsor Sinovac Life Sciences Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) Start date 2025-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Short title** PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Official title** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Dates **Completion date** 2026-11-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **First posted** 2025-05-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Registry last updated** 2025-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Primary completion date** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Start date** 2025-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Size and sites **Participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Planned participants** 400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Lead sponsor** Sinovac Life Sciences Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Identifiers **Registry ID** NCT06967272 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **ClinicalTrials.gov ID** NCT06967272 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Outcomes ### Primary outcomes 1. Evaluate the immunogenicity of the investigational vaccine at different doses Timeframe: 28 days after the full vaccination course The seroconversion rate of IgA antibodies against vaccine-type rotavirus in serum 2. Evaluate the safety of the investigational vaccine at different dose Timeframe: 0 day after the first dose till 42 days after the last dose Incidence of adverse events/reactions ### Secondary outcomes 1. Evaluate the immunogenicity of the investigational vaccine at different doses Timeframe: 28 days after the full vaccination course The positivity rate of serum anti-vaccine-type rotavirus IgA antibodies 2. Evaluate the immunogenicity of the investigational vaccine at different doses Timeframe: 28 days after the full vaccination course The geometric mean concentration (GMC) of serum anti-vaccine-type rotavirus IgA antibodies 3. Evaluate the immunogenicity of the investigational vaccine at different doses Timeframe: 28 days after the full vaccination course The geometric mean increase (GMI) of serum anti-vaccine-type rotavirus IgA antibodies 4. Evaluate the immunogenicity persistence of the investigational vaccine at different doses Timeframe: 12 months after the full vaccination course The geometric mean concentration (GMC) of serum anti-vaccine-type rotavirus IgA antibodies 5. Evaluate the immunogenicity persistence of the investigational vaccine at different doses Timeframe: 12 months after the full vaccination course The positivity rate of serum anti-vaccine-type rotavirus IgA antibodies 6. Evaluate the safety of the investigational vaccine at different dose Timeframe: 0-30 minutes after each dose Incidence of adverse events/reactions 7. Evaluate the safety of the investigational vaccine at different dose Timeframe: 0-14 days after each dose Incidence of adverse events/reactions 8. Evaluate the safety of the investigational vaccine at different dose Timeframe: The first dose to 12 months after full vaccination Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) 9. Evaluate the fecal shedding of investigated vaccine strain after vaccination Timeframe: 0-14 days after each dose The shedding rate of the rotavirus vaccine strain in the stool. 10. Evaluate the fecal shedding of investigated vaccine strain after vaccination Timeframe: 0-14 days after each dose The shedding duration of the rotavirus vaccine strain in the stool. 11. Evaluate the reassortment and reversion of the rotavirus vaccine strain in stool samples after vaccination Timeframe: 0-14 days after each dose The incidence of reassortment and reversion of the rotavirus vaccine strain in stool samples. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 6 Weeks **Maximum age** 12 Weeks **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Sites - Hubei Provincial Center for Disease Control and PreventionWuhan, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06967272) ## Related records ### Drugs (1) - [Rotavirus, live](https://trialight.com/data/asset/rotavirus-live-8b7b385a-1a1e-4351-ba68-1a88e0118ad4.md) ### Lead sponsors (1) - [Sinovac Life Sciences Co., Ltd.](https://trialight.com/data/company/sinovac-life-sciences-co-ltd-d3dbe3ae-1264-4328-a691-a71dbc1efbbc.md) ### Conditions (1) - [Rotavirus infection](https://trialight.com/data/condition/rotavirus-infection-7e79da16-09e8-58fb-861e-f85f158082a6.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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