Healthy VolunteersPhase 1NCT06350058
Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old
A Phase 1 study testing Inactivated rotavirus vaccine (low dose) and Inactivated rotavirus vaccine (high dose) in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity. Read more about this study
- Who is it for?
- Ages 6 weeks to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Inactivated rotavirus vaccine (low dose) and Inactivated rotavirus vaccine (high dose)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2021to 31 Oct 2024
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects aged 6-12 weeks, 1-5 years old, 18-49 years old, able to provide legal identification;
- The subjects or the legal guardians of the subject have the ability to understand the research procedure, agree to participate in the study (or the legal guardian of the subject agrees to the child's participation in the study), and signs an informed consent form;
- The subjects or their legals guardian are able to participate in all planned follow-up visits;
- On the day of enrollment, the axillary body temperature was ≤ 37.0 ℃;
- Standards for certain groups of people:
- Subjects aged ≥ 1 year: Laboratory test indicators (as specified in the protocol) within the normal range, or those with abnormalities but no clinical significance (evaluated by clinical doctors); Female participants of childbearing age: non pregnant, non lactating, and agreed to take effective contraceptive measures within 8 months after participating in the study.
Who cannot join
- Previously received any rotavirus vaccine;
- Previous history of acute gastroenteritis caused by rotavirus;
- Have a history of intussusception, congenital abnormalities in the digestive system, chronic diarrhea, and other diseases in the past;
- Have any history of severe allergies to vaccines or drugs in the past, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthurs reaction);
- Suffering from serious congenital malformations, developmental disorders, and genetic defects that may interfere with the progress or completion of the study (including but not limited to: Down syndrome, thalassemia, etc.);
- Diagnosed with congenital or acquired immunodeficiency, or suspected of having systemic diseases that may interfere with the conduct or completion of the study, such as tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis infection, etc;
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- Having a history or family history of convulsions, epilepsy, encephalopathy, and mental illness;
- Suffering from contraindications for intramuscular injection such as thrombocytopenia, any coagulation disorders, or receiving anticoagulant therapy;
- Recently receiving immunosuppressive therapy, such as systemic glucocorticoid therapy for more than 2 weeks continuously after birth or 6 months before vaccination, such as prednisone or similar drugs using >5mg/day (note: local and inhaled/nebulized steroids can be used);
- Any absence of spleen or splenectomy, functional absence of spleen caused by any circumstances;
- Hypertensive subjects (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, suitable for adults);
- Three days prior to the first dose of the vaccine, there was an acute illness or a period of acute exacerbation of a chronic disease;
- Received inactivated vaccine within 7 days before enrollment and attenuated live vaccine within 14 days;
- Have received blood or blood related products or immunoglobulin (acceptable for hepatitis B immunoglobulin) within 3 months prior to enrollment;
- Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
- The researchers believe that there are any conditions in the subjects that may interfere with the evaluation of the research objectives;
- Standards for certain groups of people:
- Subjects aged 6-12 weeks: single fetus gestational age<37 weeks or>42 weeks, birth weight<2.5kg or>4.0kg; multiple fetuses; abnormal birth process (difficult labor, instrumental midwifery) or a history of asphyxia and neurological damage; children with pathological jaundice.
Trial locations and contacts
1 site in 1 country.
China1 site
Hebei Provincial Center for Disease Control and Prevention
Shijiangzhuang, Hebei, 050021
About this study
Official title: A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evalution the Safety, Tolerability of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old
The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.
Read the detailed description
This is a Phase I, single center, randomized, double-blind, placebo-controlled, dose escalation clinical trial conducted in Hebei Province, China. The purpose of this study is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.
- Conditions
- Healthy Volunteers
- Being tested
- Inactivated rotavirus vaccine (low dose), Inactivated rotavirus vaccine (high dose), Placebo
- Keywords
- Inactivated Rotavirus Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated rotavirus vaccine (low dose)Biological
The protein content of each dose is 2.5 μg. The antigen content shall not be less than 2000U, and each person shall receive one dose of 0.5ml.
Inactivated rotavirus vaccine (high dose)Biological
The protein content of each dose is 5 μg. The antigen content shall not be less than 4000U, and each person shall receive one dose of 0.5ml.
PlaceboBiological
Aluminum hydroxide adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| Age group of 18-49 years old | Experimental | Using a dose escalation trial, divided into 2 dose groups with 25 participants in each group. Receives: Biological: Inactivated rotavirus vaccine (low dose); Biological: Inactivated rotavirus vaccine (high dose); Biological: Placebo |
| Age group of 1-5 years old | Experimental | Using a dose escalation trial, divided into 2 dose groups with 25 participants in each group. Receives: Biological: Inactivated rotavirus vaccine (low dose); Biological: Inactivated rotavirus vaccine (high dose); Biological: Placebo |
| Age group of 6-12 months old | Experimental | Using a dose escalation trial, divided into 2 dose groups with 25 participants in each group.
In addition, a dose exploration trial was conducted, with a total of 225 subjects aged 6-12 weeks enrolled, with 100 participants in both high-dose and low-dose groups, and 25 participants in the placebo control group Receives: Biological: Inactivated rotavirus vaccine (low dose); Biological: Inactivated rotavirus vaccine (high dose); Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of AE
The incidence of all adverse events within 0-30 days after each dose of vaccination
Measured: 0~30 day after vaccination
Incidence rate of SAE
The incidence of all SAE from the start of the first dose of vaccination to the 6 months after achieving the entire immunization process
Measured: From the first dose of vaccination to the 6 months after achieving the entire immunization process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start3 Aug 2021
- Primary completion30 Nov 2023
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Du, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350058
- Sponsor's protocol ID
- 202012005
- Status last verified
- Mar 2024
- First submitted
- 1 Apr 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evalution the Safety, Tolerability of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old
- ClinicalTrials.gov ID
- NCT06350058
- Acronym / sponsor ID
- 202012005
- Conditions
- Healthy Volunteers
- Keywords
- Inactivated Rotavirus Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 5 Apr 2024 (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 research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.
Detailed description
This is a Phase I, single center, randomized, double-blind, placebo-controlled, dose escalation clinical trial conducted in Hebei Province, China. The purpose of this study is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity.
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 |
|---|---|---|
| Age group of 18-49 years old | Experimental | Biological: Inactivated rotavirus vaccine (low dose), Biological: Inactivated rotavirus vaccine (high dose), Biological: PlaceboUsing a dose escalation trial, divided into 2 dose groups with 25 participants in each group. |
| Age group of 1-5 years old | Experimental | Biological: Inactivated rotavirus vaccine (low dose), Biological: Inactivated rotavirus vaccine (high dose), Biological: PlaceboUsing a dose escalation trial, divided into 2 dose groups with 25 participants in each group. |
| Age group of 6-12 months old | Experimental | Biological: Inactivated rotavirus vaccine (low dose), Biological: Inactivated rotavirus vaccine (high dose), Biological: PlaceboUsing a dose escalation trial, divided into 2 dose groups with 25 participants in each group. In addition, a dose exploration trial was conducted, with a total of 225 subjects aged 6-12 weeks enrolled, with 100 participants in both high-dose and low-dose groups, and 25 participants in the placebo control group |
Who may qualify
- Ages
- 6 weeks to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Subjects aged 6-12 weeks, 1-5 years old, 18-49 years old, able to provide legal identification;
- The subjects or the legal guardians of the subject have the ability to understand the research procedure, agree to participate in the study (or the legal guardian of the subject agrees to the child's participation in the study), and signs an informed consent form;
- The subjects or their legals guardian are able to participate in all planned follow-up visits;
- On the day of enrollment, the axillary body temperature was ≤ 37.0 ℃;
- Standards for certain groups of people:
Key exclusion criteria (18 listed)
- Previously received any rotavirus vaccine;
- Previous history of acute gastroenteritis caused by rotavirus;
- Have a history of intussusception, congenital abnormalities in the digestive system, chronic diarrhea, and other diseases in the past;
- Have any history of severe allergies to vaccines or drugs in the past, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthurs reaction);
- Suffering from serious congenital malformations, developmental disorders, and genetic defects that may interfere with the progress or completion of the study (including but not limited to: Down syndrome, thalassemia, etc.);
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 |
|---|---|---|
| Inactivated rotavirus vaccine (low dose)The protein content of each dose is 2.5 μg. The antigen content shall not be less than 2000U, and each person shall receive one dose of 0.5ml. | Biological | Age group of 1-5 years old, Age group of 18-49 years old, Age group of 6-12 months old |
| Inactivated rotavirus vaccine (high dose)The protein content of each dose is 5 μg. The antigen content shall not be less than 4000U, and each person shall receive one dose of 0.5ml. | Biological | Age group of 1-5 years old, Age group of 18-49 years old, Age group of 6-12 months old |
| PlaceboAluminum hydroxide adjuvant. | Biological | Age group of 1-5 years old, Age group of 18-49 years old, Age group of 6-12 months old |
Primary outcome
Incidence rate of AE
Time frame: 0~30 day after vaccination
The incidence of all adverse events within 0-30 days after each dose of vaccination
Incidence rate of SAE
Time frame: From the first dose of vaccination to the 6 months after achieving the entire immunization process
The incidence of all SAE from the start of the first dose of vaccination to the 6 months after achieving the entire immunization process
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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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.
Lin Du study chair
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
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 Inactivated rotavirus vaccine (low dose) and Inactivated rotavirus vaccine (high dose) in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical 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 6 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. 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 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?
Results are not available in the source record.
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?
Incidence rate of AE (time frame: 0~30 day after vaccination). 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 5 Apr 2024.