Rotavirus GastroenteritisPhase 2NCT06967272
PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
A Phase 2 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 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… Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy 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?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 15 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, 430079
Yeqing Tong, +86-13971078410, 63382251@qq.com
About this study
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.
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.
Read the detailed description
The Phase II clinical trial is a randomized, double-blind, active-controlled study conducted in healthy infants to evaluate the immunogenicity and safety of the investigational vaccine. The investigational vaccine is available in both high-dose and low-dose formulations. The control vaccine is the orally administered pentavalent reassortant rotavirus attenuated live vaccine (Vero Cells) produced by Merck Sharp \& Dohme Corp.
This study plans to recruit 400 infants aged 6 to 12 weeks. All participants will be randomly assigned to the low-dose investigational group, high-dose investigational group, and active-controlled group, respectively.The immunization schedule for both the investigational vaccine and controlled vaccine consists of three doses administered at 28-day intervals.
Blood samples will be collected at predefined time points to evaluate the immunogenicity of the investigational vaccine. Adverse events (AEs) will be collected for all participants from the first vaccination until 42 days after the last dose, while serious adverse events (SAEs) and adverse events of special interest (AESIs) will be monitored for 12 months.
A safety monitoring sub-cohort will be established, with stool samples collected daily for 14 days after each vaccination to assess vaccine virus shedding, duration and patterns of viral shedding, potential reassortment and reversion to virulence of the rotavirus vaccine strains
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Oral hexavalent reassortant rotavirus attenuated live vaccine, Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled)
- Keywords
- Phase II, Immunogenicity, Safety, Randomized Controlled Trial, 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 (low-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 pentavalent reassortant rotavirus attenuated live vaccine (controlled)Biological
The controlled vaccine three doses administered orally
| Study group | Role | What they receive |
|---|---|---|
| Low dose | 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 |
| High dose | 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 |
| Control | Active comparator | The controlled vaccine will be administered in three doses, with a 28-day interval between each dose. Receives: Biological: Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the immunogenicity of the investigational vaccine at different doses
The seroconversion rate of IgA antibodies against vaccine-type rotavirus in serum
Measured: 28 days after the full vaccination course
Evaluate the safety of the investigational vaccine at different dose
Incidence of adverse events/reactions
Measured: 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
The positivity rate of serum anti-vaccine-type rotavirus IgA antibodies
Measured: 28 days after the full vaccination course
Evaluate the immunogenicity of the investigational vaccine at different doses
The geometric mean concentration (GMC) of serum anti-vaccine-type rotavirus IgA antibodies
Measured: 28 days after the full vaccination course
Evaluate the immunogenicity of the investigational vaccine at different doses
The geometric mean increase (GMI) of serum anti-vaccine-type rotavirus IgA antibodies
Measured: 28 days after the full vaccination course
Evaluate the immunogenicity persistence of the investigational vaccine at different doses
The geometric mean concentration (GMC) of serum anti-vaccine-type rotavirus IgA antibodies
Measured: 12 months after the full vaccination course
Evaluate the immunogenicity persistence of the investigational vaccine at different doses
The positivity rate of serum anti-vaccine-type rotavirus IgA antibodies
Measured: 12 months after the full vaccination course
Evaluate the safety of the investigational vaccine at different dose
Incidence of adverse events/reactions
Measured: 0-30 minutes after each dose
Evaluate the safety of the investigational vaccine at different dose
Incidence of adverse events/reactions
Measured: 0-14 days after each dose
Evaluate the safety of the investigational vaccine at different dose
Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
Measured: The first dose to 12 months after full vaccination
Evaluate the fecal shedding of investigated vaccine strain 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 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 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 posted13 May 2025
- Study start20 Jan 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
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
- NCT06967272
- Sponsor's protocol ID
- PRO-RV-2001
- Status last verified
- Aug 2025
- First submitted
- 26 Apr 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06967272
- Acronym / sponsor ID
- PRO-RV-2001
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- Phase II, Immunogenicity, Safety, Randomized Controlled Trial, Rotavirus gastroenteritis, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sinovac Life Sciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 13 May 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 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.
Detailed description
The Phase II clinical trial is a randomized, double-blind, active-controlled study conducted in healthy infants to evaluate the immunogenicity and safety of the investigational vaccine. The investigational vaccine is available in both high-dose and low-dose formulations. The control vaccine is the orally administered pentavalent reassortant rotavirus attenuated live vaccine (Vero Cells) produced by Merck Sharp \& Dohme Corp.
This study plans to recruit 400 infants aged 6 to 12 weeks. All participants will be randomly assigned to the low-dose investigational group, high-dose investigational group, and active-controlled group, respectively.The immunization schedule for both the investigational vaccine and controlled vaccine consists of three doses administered at 28-day intervals.
Blood samples will be collected at predefined time points to evaluate the immunogenicity of the investigational vaccine. Adverse events (AEs) will be collected for all participants from the first vaccination until 42 days after the last dose, while serious adverse events (SAEs) and adverse events of special interest (AESIs) will be monitored for 12 months.
A safety monitoring sub-cohort will be established, with stool samples collected daily for 14 days after each vaccination to assess vaccine virus shedding, duration and patterns of viral shedding, potential reassortment and reversion to virulence of the rotavirus vaccine strains
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | 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. |
| High dose | 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. |
| Control | Active comparator | Biological: Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled)The controlled vaccine will be administered in three doses, with a 28-day interval between each dose. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
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 (low-dose) three doses administered orally | Biological | Low dose |
| Oral hexavalent reassortant rotavirus attenuated live vaccineOral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally | Biological | High dose |
| Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled)The controlled vaccine three doses administered orally | Biological | Control |
Primary outcome
Evaluate the immunogenicity of the investigational vaccine at different doses
Time frame: 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
Time frame: 0 day after the first dose till 42 days after the last dose
Incidence of adverse events/reactions
11 secondary outcomes
Evaluate the immunogenicity of the investigational vaccine at different doses
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity of the investigational vaccine at different doses
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity of the investigational vaccine at different doses
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity persistence of the investigational vaccine at different doses
Time frame: 12 months after the full vaccination course
Evaluate the immunogenicity persistence of the investigational vaccine at different doses
Time frame: 12 months after the full vaccination course
Evaluate the safety of the investigational vaccine at different dose
Time frame: 0-30 minutes after each dose
Evaluate the safety of the investigational vaccine at different dose
Time frame: 0-14 days after each dose
Evaluate the safety of the investigational vaccine at different dose
Time frame: The first dose to 12 months after full vaccination
Evaluate the fecal shedding of investigated vaccine strain after vaccination
Time frame: 0-14 days after each dose
Evaluate the fecal shedding of investigated vaccine strain after vaccination
Time frame: 0-14 days after each dose
Evaluate the reassortment and reversion of the rotavirus vaccine strain in stool samples after vaccination
Time frame: 0-14 days after each dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 20 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeqing Tong (+86-13971078410, 63382251@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the immunogenicity of the investigational vaccine at different doses (time frame: 28 days after the full vaccination course). The study lists 2 primary outcomes in all. 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 22 Aug 2025.