Rotavirus GastroenteritisPhase 1NCT06950645
The Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
A Phase 1 study testing Oral hexavalent reassortant rotavirus attenuated live vaccine in people with Rotavirus Gastroenteritis, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
Trial summary
The Phase I clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in a population ranging from 6 weeks to 59 years of age. Read more about this study
- Who is it for?
- Ages 6 weeks to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Gastroenteritis
- What is being tested?
- Oral hexavalent reassortant rotavirus attenuated live vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2024to 18 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The participant and/or their guardian is willing and able to comply with all study procedures, sign the informed consent form, and remain contactable throughout the study period.
- Provide legal identification.
- Male or female, aged 6 to 12 weeks, or 2 to 6 years, or 18 to 59 years, and in good health.
- Fertile participants have no plans for pregnancy from the time of signing the informed consent form until 3 months after the last dose of the study vaccine and agree to use effective contraception, and have no plans for sperm or egg donation.
Who cannot join
- Known allergy to the vaccine or its components, such as urticaria, dyspnea, angioedema, etc.
- Current diarrhea or vomiting, or other gastrointestinal diseases, or having experienced gastroenteritis or any acute illness or acute exacerbation of chronic disease within the past 7 days, or those currently using antibiotics or antiviral therapy.
- History of intussusception or chronic gastrointestinal disease, including gastrointestinal congenital anomalies that can easily cause intussusception (e.g., Meckel's diverticulum).
- For infant and pediatric participants: congenital malformations or developmental disabilities, genetic defect diseases, severe malnutrition, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome); For adult participants: uncontrolled chronic diseases or severe disease history, including but not limited to cardiovascular diseases (such as drug-uncontrolled hypertension, i.e., systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), hematologic diseases, hepatic and renal diseases, gastrointestinal diseases, respiratory diseases, malignant tumors, history of major organ transplantation, or any other disease or medical condition that the investigator believes may interfere with the trial results.
- Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection).
- Household members living with the participant are in an immunodeficient or immunosuppressed state or are currently/soon to be receiving immunosuppressive therapy, cytotoxic therapy, etc.
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- Presence of coagulation dysfunction (such as deficiency of coagulation factors, abnormal platelets).
- Received >14 days of immunosuppressive therapy or other immunomodulatory therapy, cytotoxic therapy within the past 6 months (for adult and pediatric participants) or since birth (for infant participants), or planned to receive such treatment during the study period.
- Chronic alcoholism [weekly alcohol consumption >14 drinking units (1 drinking unit = 14 grams of 100% alcohol = 360 mL beer, or 150 mL wine, or 45 mL distilled spirits/liquor)] or history of drug abuse (repeated, excessive use of narcotic drugs, psychotropic substances, volatile organic solvents, etc.) (for adult participants).
- Suffering from/having suffered from severe neurological diseases (epilepsy, convulsions or seizures) or mental illness, or having a family history of the same.
- Received immunoglobulin or other blood products within 6 months before receiving the trial vaccine (for adult and pediatric groups) or in the past (for infant group), or planned to receive such treatment during the study period.
- Received other investigational drugs or vaccines within the past 30 days, or planned to receive such drugs or vaccines during the study period.
- Received live attenuated vaccines or COVID-19 vaccines within the past 14 days, or subunit or inactivated vaccines and other process vaccines within the past 7 days.
- Had axillary temperature ≥38.0℃ within the past 3 days.
- On the day planned for vaccination with the trial vaccine, having a fever with axillary temperature >37.0℃.
- Clinical laboratory tests showing laboratory abnormalities beyond the reference range that are clinically significant (for adult and pediatric groups):
- Hematology test indicators: white blood cell count, hemoglobin, platelet count.
- Biochemical blood test indicators: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose (Glu).
- Urinalysis test indicators: urine protein (PRO).
- Fertile women with positive urine pregnancy test or breastfeeding.
- 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.
- Additional Exclusion Criteria for Infants Aged 6 to 12 Weeks
- Previously received rotavirus vaccine.
- History of rotavirus infection.
- Neonatal gestational age <37 weeks or ≥42 weeks.
- Birth weight <2500g.
- History of difficult labor, resuscitation from asphyxia, or neurological damage at birth.
Trial locations and contacts
1 site in 1 country.
China1 site
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, 050021
About this study
Official title: The Open-label Observation of Oral Hexavalent Reassorted Rotavirus Live Attenuated Vaccine (Vero Cell) in Healthy Adults and Children, as Well as the Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity in Healthy Infants
The Phase I clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in a population ranging from 6 weeks to 59 years of age.
The objective of this study is to evaluate the safety of investigational vaccine in healthy adults and children, as well as its safety tolerability, and immunogenicity in healthy infants.
The study will be an open-label observation in adults and children, and a randomized, double-blind, placebo-controlled clinical trial in infants.
Read the detailed description
The Phase I clinical trial is an open-label observation involving healthy adults and children, as well as a randomized, double-blind, placebo-controlled study in healthy infants to evaluate the safety, tolerability, and immunogenicity of the investigaional vaccine. The investigational vaccine is available in both high-dose and low-dose formulations. The placebo is identical to the trial vaccine in all components except for the rotavirus.
This study will enroll 100 participants, consisting of 20 adults aged 18-59 years, 20 children aged 2-6 years, and 60 infants aged 6-12 weeks. Participants will be enrolled sequentially, starting with adults, followed by children, and then infants. Enrollment for the subsequent group will begin after a 14-day safety observation period and confirmation of acceptable safety in the preceding group. Adult and child participants will receive the investigational vaccine in an open-label manner. The infants will be enrolled into two cohorts of 30 participants each: a low-dose cohort and a high-dose cohort. Within each cohort, the infants will be randomly assigned to two groups at a ratio of 2:1 and will receive either the investigational vaccine or a placebo in a double-blind manner. The immunization schedule for both the vaccine and placebo consists of three doses administered at 28-day intervals.
Adverse events (AE) will be collected for all participants until 42 days after the last dose vaccination. Stool samples will be collected after each vaccination to detect vaccine strain shedding among infant participants. Serious adverse events (SAE) will be observed for 6 months from the last dose for adults and children or 12 months for infants. Blood samples from the infants will be collected at predetermined times to evaluate the immunogenicity of the investigational vaccine.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Oral hexavalent reassortant rotavirus attenuated live vaccine, Placebo
- Keywords
- Phase I, sequential design, safety, tolerability, immunogenicity, Rotavirus gastroenteritis, vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hexavalent reassortant rotavirus attenuated live vaccineBiological
Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
Oral hexavalent reassortant rotavirus attenuated live vaccineBiological
Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
Oral hexavalent reassortant rotavirus attenuated live vaccineBiological
Oral hexavalent reassortant rotavirus attenuated live vaccine (low-dose) three doses administered orally
PlaceboBiological
Placebo of experimental vaccine for infants three doses administered orally
Oral hexavalent reassortant rotavirus attenuated live vaccineBiological
Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
PlaceboBiological
Placebo of experimental vaccine for infants three doses administered orally
| Study group | Role | What they receive |
|---|---|---|
| Adult | Experimental | The experimental vaccine will be administered in three doses, with a 28-day interval between each dose. Receives: Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine |
| Children | Experimental | The experimental vaccine will be administered in three doses, with a 28-day interval between each dose Receives: Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine |
| Infants low-dose 1 | Experimental | They will receive three low-dose experimental vaccine in a double-blind setting, with a 28-day interval between each dose. Receives: Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine |
| Infants low-dose 2 | Placebo comparator | They will receive three doses of the placebo in a double-blind setting, with a 28-day interval between each dose Receives: Biological: Placebo |
| Infants high-dose 1 | Experimental | They will receive three high-dose experimental vaccine in a double-blind setting, with a 28-day interval between each dose Receives: Biological: Oral hexavalent reassortant rotavirus attenuated live vaccine |
| Infants high-dose 2 | Placebo comparator | They will receive three doses of the placebo in a double-blind setting,with a 28-day interval between each dose Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of the investigational vaccine
Incidence of adverse events/reactions
Measured: 0 day after the first dose till 42 days after the last dose
Secondary outcomes (14)
Evaluate the safety of the investigational vaccine
Incidence of adverse events/reactions
Measured: 0-14 days after each dose
Evaluate the safety of the investigational vaccine
Incidence of adverse events/reactions
Measured: 0-30 minutes after each dose
Evaluate the safety of the investigational vaccine in the healthy adults and children groups
Incidence of clinically significant abnormal laboratory parameters on day 3 after each dose in adult and children groups
Measured: day 3 after each dose
Evaluate the safety of the investigational vaccine
Incidence of serious adverse events (SAEs)
Measured: Within 6 months after the last dose
Evaluate the safety of the investigational vaccine in the healthy infant group
Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
Measured: Within 12 months after the last dose in the infant group
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Seroconversion rate of serum IgA antibodies against vaccine serotype rotavirus.
Measured: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Seropositivity rate of serum IgA antibodies against vaccine serotype rotavirus.
Measured: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Geometric mean concentration (GMC) of serum IgA antibodies against vaccine serotype rotavirus.
Measured: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Geometric mean increase (GMI) of serum IgA antibodies against vaccine serotype rotavirus.
Measured: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Seropositivity rate of serum IgA antibodies against vaccine serotype rotavirus
Measured: 6 months and 12 months after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Geometric mean concentration (GMC) of serum IgA antibodies against vaccine serotype rotavirus
Measured: 6 months and 12 months after the full vaccination course
Evaluate the fecal shedding of investigated vaccine strain in healthy infants after vaccination.
The shedding rate of the rotavirus vaccine strain in the stool.
Measured: 0-14 days after each dose
Evaluate the fecal shedding of investigated vaccine strain in healthy infants after vaccination.
The shedding duration of the rotavirus vaccine strain in the stool.
Measured: 0-14 days after each dose
Evaluate the reassortment and reversion of the rotavirus vaccine strain in stool samples of healthy infants after vaccination
The incidence of reassortment and reversion of the rotavirus vaccine strain in stool samples.
Measured: 0-14 days after each dose,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start27 Mar 2024
- Primary completion21 Dec 2024
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study features a single-arm, open-label design for the adult and children groups, and a randomized, double-blind, placebo-controlled design for the infant group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950645
- Sponsor's protocol ID
- PRO-RV-1001
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Open-label Observation of Oral Hexavalent Reassorted Rotavirus Live Attenuated Vaccine (Vero Cell) in Healthy Adults and Children, as Well as the Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity in Healthy Infants
- ClinicalTrials.gov ID
- NCT06950645
- Acronym / sponsor ID
- PRO-RV-1001
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- Phase I, sequential design, safety, tolerability, immunogenicity, Rotavirus gastroenteritis, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 21 Dec 2024 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Phase I clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in a population ranging from 6 weeks to 59 years of age.
The objective of this study is to evaluate the safety of investigational vaccine in healthy adults and children, as well as its safety tolerability, and immunogenicity in healthy infants.
The study will be an open-label observation in adults and children, and a randomized, double-blind, placebo-controlled clinical trial in infants.
Detailed description
The Phase I clinical trial is an open-label observation involving healthy adults and children, as well as a randomized, double-blind, placebo-controlled study in healthy infants to evaluate the safety, tolerability, and immunogenicity of the investigaional vaccine. The investigational vaccine is available in both high-dose and low-dose formulations. The placebo is identical to the trial vaccine in all components except for the rotavirus.
This study will enroll 100 participants, consisting of 20 adults aged 18-59 years, 20 children aged 2-6 years, and 60 infants aged 6-12 weeks. Participants will be enrolled sequentially, starting with adults, followed by children, and then infants. Enrollment for the subsequent group will begin after a 14-day safety observation period and confirmation of acceptable safety in the preceding group. Adult and child participants will receive the investigational vaccine in an open-label manner. The infants will be enrolled into two cohorts of 30 participants each: a low-dose cohort and a high-dose cohort. Within each cohort, the infants will be randomly assigned to two groups at a ratio of 2:1 and will receive either the investigational vaccine or a placebo in a double-blind manner. The immunization schedule for both the vaccine and placebo consists of three doses administered at 28-day intervals.
Adverse events (AE) will be collected for all participants until 42 days after the last dose vaccination. Stool samples will be collected after each vaccination to detect vaccine strain shedding among infant participants. Serious adverse events (SAE) will be observed for 6 months from the last dose for adults and children or 12 months for infants. Blood samples from the infants will be collected at predetermined times to evaluate the immunogenicity of the investigational vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- This study features a single-arm, open-label design for the adult and children groups, and a randomized, double-blind, placebo-controlled design for the infant group.
| Arm | Type | Receives |
|---|---|---|
| Adult | Experimental | Biological: Oral hexavalent reassortant rotavirus attenuated live vaccineThe experimental vaccine will be administered in three doses, with a 28-day interval between each dose. |
| Children | Experimental | Biological: Oral hexavalent reassortant rotavirus attenuated live vaccineThe experimental vaccine will be administered in three doses, with a 28-day interval between each dose |
| Infants low-dose 1 | Experimental | Biological: Oral hexavalent reassortant rotavirus attenuated live vaccineThey will receive three low-dose experimental vaccine in a double-blind setting, with a 28-day interval between each dose. |
| Infants low-dose 2 | Placebo comparator | Biological: PlaceboThey will receive three doses of the placebo in a double-blind setting, with a 28-day interval between each dose |
| Infants high-dose 1 | Experimental | Biological: Oral hexavalent reassortant rotavirus attenuated live vaccineThey will receive three high-dose experimental vaccine in a double-blind setting, with a 28-day interval between each dose |
| Infants high-dose 2 | Placebo comparator | Biological: PlaceboThey will receive three doses of the placebo in a double-blind setting,with a 28-day interval between each dose |
Who may qualify
- Ages
- 6 weeks to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- The participant and/or their guardian is willing and able to comply with all study procedures, sign the informed consent form, and remain contactable throughout the study period.
- Provide legal identification.
- Male or female, aged 6 to 12 weeks, or 2 to 6 years, or 18 to 59 years, and in good health.
- Fertile participants have no plans for pregnancy from the time of signing the informed consent form until 3 months after the last dose of the study vaccine and agree to use effective contraception, and have no plans for sperm or egg donation.
Key exclusion criteria (28 listed)
- Known allergy to the vaccine or its components, such as urticaria, dyspnea, angioedema, etc.
- Current diarrhea or vomiting, or other gastrointestinal diseases, or having experienced gastroenteritis or any acute illness or acute exacerbation of chronic disease within the past 7 days, or those currently using antibiotics or antiviral therapy.
- History of intussusception or chronic gastrointestinal disease, including gastrointestinal congenital anomalies that can easily cause intussusception (e.g., Meckel's diverticulum).
- For infant and pediatric participants: congenital malformations or developmental disabilities, genetic defect diseases, severe malnutrition, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome); For adult participants: uncontrolled chronic diseases or severe disease history, including but not limited to cardiovascular diseases (such as drug-uncontrolled hypertension, i.e., systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), hematologic diseases, hepatic and renal diseases, gastrointestinal diseases, respiratory diseases, malignant tumors, history of major organ transplantation, or any other disease or medical condition that the investigator believes may interfere with the trial results.
- Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral hexavalent reassortant rotavirus attenuated live vaccineOral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally | Biological | Adult |
| Oral hexavalent reassortant rotavirus attenuated live vaccineOral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally | Biological | Children |
| Oral hexavalent reassortant rotavirus attenuated live vaccineOral hexavalent reassortant rotavirus attenuated live vaccine (low-dose) three doses administered orally | Biological | Infants low-dose 1 |
| PlaceboPlacebo of experimental vaccine for infants three doses administered orally | Biological | Infants low-dose 2 |
| Oral hexavalent reassortant rotavirus attenuated live vaccineOral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally | Biological | Infants high-dose 1 |
| PlaceboPlacebo of experimental vaccine for infants three doses administered orally | Biological | Infants high-dose 2 |
Primary outcome
Evaluate the safety of the investigational vaccine
Time frame: 0 day after the first dose till 42 days after the last dose
Incidence of adverse events/reactions
14 secondary outcomes
Evaluate the safety of the investigational vaccine
Time frame: 0-14 days after each dose
Evaluate the safety of the investigational vaccine
Time frame: 0-30 minutes after each dose
Evaluate the safety of the investigational vaccine in the healthy adults and children groups
Time frame: day 3 after each dose
Evaluate the safety of the investigational vaccine
Time frame: Within 6 months after the last dose
Evaluate the safety of the investigational vaccine in the healthy infant group
Time frame: Within 12 months after the last dose in the infant group
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Time frame: 6 months and 12 months after the full vaccination course
Evaluate the immunogenicity and immune persistence of the investigated vaccine in healthy infants.
Time frame: 6 months and 12 months after the full vaccination course
Evaluate the fecal shedding of investigated vaccine strain in healthy infants after vaccination.
Time frame: 0-14 days after each dose
Evaluate the fecal shedding of investigated vaccine strain in healthy infants after vaccination.
Time frame: 0-14 days after each dose
Evaluate the reassortment and reversion of the rotavirus vaccine strain in stool samples of healthy infants after vaccination
Time frame: 0-14 days after each dose,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral hexavalent reassortant rotavirus attenuated live vaccine in people with Rotavirus Gastroenteritis, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of the investigational vaccine (time frame: 0 day after the first dose till 42 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.