PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
- 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.
- Short title
- PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
- 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.
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-11-15
- First posted
- 2025-05-13
- Registry last updated
- 2025-08-22
- Primary completion date
- 2026-06-15
- Start date
- 2025-01-20
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06967272
- ClinicalTrials.gov ID
- NCT06967272
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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
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
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
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
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
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
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
Evaluate the safety of the investigational vaccine at different dose
Timeframe: 0-30 minutes after each dose
Incidence of adverse events/reactions
Evaluate the safety of the investigational vaccine at different dose
Timeframe: 0-14 days after each dose
Incidence of adverse events/reactions
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)
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.
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.
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.
- Sex
- All
- Age groups
- Children
- Minimum age
- 6 Weeks
- Maximum age
- 12 Weeks
- Healthy volunteers
- Yes
- 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.
- 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.
- Receipt of live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment.
- Axillary temperature ≥38.0°C within the past 3 days.
- Fever on scheduled vaccination day (axillary temperature >37.0°C; measured ≥30 minutes post-feeding).
- Currently or planning to participate in other vaccine or drug clinical trials.
- Any other factors that the investigator deems unsuitable for participation in the clinical trial.
- Hubei Provincial Center for Disease Control and PreventionWuhan, ChinaRecruiting
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Rotavirus infection Primary condition