Healthy VolunteersPhase 2NCT05913024
Immunogenicity and Safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in Volunteers Aged From 6 to 71 Months
A Phase 2 study testing Enterovirus Type 71 Vaccine in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months. Read more about this study
- Who is it for?
- Ages 6 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Enterovirus Type 71 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2021to 24 Oct 2022
- Phase
- Phase 2
- 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 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-71 months, valid identification;
- Infants aged 6-11 months should be full-term (37-42 weeks gestation) and have a birth weight (2500g≤ weight ≤4000g);
- The subject's guardian voluntarily consented to the child's participation in the study and signed an informed consent form;
- The subject's guardian had the ability to learn about the study procedure and was able to participate in all planned follow-ups;
- Pre-enrollment axillary body temperature < 37.5°C.
Who cannot join
- Have received any previous HFMD vaccine;
- Previous history of hand, foot and mouth disease；
- History of allergies to any component of the study vaccine or substances used in the preparation process，or a history of severe adverse effects of vaccine/drug；
- Have a serious congenital malformation or chronic medical condition that may interfere with the conduct or completion of the study；
- History of seizures, epilepsy, encephalopathy, and psychosis (including family history)；
- Have contraindications to intramuscular injections such as thrombocytopenia, any coagulopathy, or being treated with anticoagulants；
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- Have an infectious disease with clinical or serological evidence；
- Patients with asplenia, splenectomy, or functional asplenia due to any condition；
- Patients with congenital or acquired immunodeficiency; or receive systemic corticosteroids within 3 months prior to enrollment, or be on other immunosuppressants prior to enrollment；
- Have received treatment with blood or blood-related products within 3 months prior to enrollment；
- Have acute illness or are in an acute exacerbation of chronic disease within 3 days prior to the first dose of vaccination, or antipyretic, analgesic, and antiallergic medications have been used；
- Have received any inactivated vaccine within 7 days before the first dose, and any live attenuated vaccine within 14 days prior to vaccination；
- Severely abnormal labor (dystocia at birth, instrumental delivery, excluding caesarean section) or history of asphyxia, neurological damage, IVF or multiple births, pathological jaundice (only for infants 6 to 11 months of age)；
- Those who plan to move before the end of the study visit or who are away from the local area for an extended period of time during the scheduled study visit；
- Ongoing or planned participation in clinical trials of other drugs；
- The investigators considered that the participants had any conditions that might interfere with the assessment of the purpose of the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 410005
About this study
Official title: A Single-center, Randomized, Blinded, Different Doses, Positive Control, Phase II to Evaluate the Inactivated EV71 Vaccine Immunogenicity and Safety in Healthy Volunteers Aged 6 to 71 Months
The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.
Read the detailed description
The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.
Qualified subjects were screened and randomly divided into low-dose group, high-dose group, and control group according to the ratio of 2:2:1. The experimental group was vaccinated with the experimental vaccine (low-dose or high-dose enterovirus 71 inactivated vaccine from Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd.), and the control group was vaccinated with the control vaccine (enterovirus 71 inactivated vaccine produced by the Institute of Medical Biology of the Chinese Academy of Medical Sciences). All participants received two doses of the vaccine 28 days apart.
- Conditions
- Healthy Volunteers
- Being tested
- Enterovirus Type 71 Vaccine
- Keywords
- Enterovirus Type 71 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterovirus Type 71 VaccineBiological
Participants received two doses of the vaccine, 28 days apart
| Study group | Role | What they receive |
|---|---|---|
| Enterovirus Type 71 Vaccine,Inactivated(Vero Cells),high dose | Experimental | Participants received two doses of the vaccine, 28 days apart Receives: Biological: Enterovirus Type 71 Vaccine |
| Enterovirus Type 71 Vaccine,Inactivated(Vero Cells),low dose | Experimental | Participants received two doses of the vaccine, 28 days apart Receives: Biological: Enterovirus Type 71 Vaccine |
| Enterovirus Type 71 Vaccine,Inactivated(Human Diploid Cell) | Active comparator | Participants received two doses of the vaccine, 28 days apart Receives: Biological: Enterovirus Type 71 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-EV71 serum neutralizing antibody positive conversion rate at 28 days after immunization
to evaluate immunogenicity of Enterovirus Type 71 Vaccine
Measured: 28 days after two doses of vaccination
Geometric mean titer (GMT) and growth factor of anti-EV71 serum neutralizing antibody 28 days after immunization
to evaluate immunogenicity of Enterovirus Type 71 Vaccine
Measured: 28 days after two doses of vaccination
Ratio of subjects with anti-EV71 serum neutralizing antibody titer ≥ 1:8 28 days after immunization
to evaluate immunogenicity of Enterovirus Type 71 Vaccine
Measured: 28 days after two doses of vaccination
Adverse events within 0-28 days after each dose of vaccination
to evaluate Safety of Enterovirus Type 71 Vaccine
Measured: 28 days after each dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start19 Oct 2021
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Du lin, master, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913024
- Sponsor's protocol ID
- 202101025
- Status last verified
- Jul 2023
- First submitted
- 12 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Blinded, Different Doses, Positive Control, Phase II to Evaluate the Inactivated EV71 Vaccine Immunogenicity and Safety in Healthy Volunteers Aged 6 to 71 Months
- ClinicalTrials.gov ID
- NCT05913024
- Acronym / sponsor ID
- 202101025
- Conditions
- Healthy Volunteers
- Keywords
- Enterovirus Type 71 Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 22 Jun 2023 (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 goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.
Detailed description
The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.
Qualified subjects were screened and randomly divided into low-dose group, high-dose group, and control group according to the ratio of 2:2:1. The experimental group was vaccinated with the experimental vaccine (low-dose or high-dose enterovirus 71 inactivated vaccine from Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd.), and the control group was vaccinated with the control vaccine (enterovirus 71 inactivated vaccine produced by the Institute of Medical Biology of the Chinese Academy of Medical Sciences). All participants received two doses of the vaccine 28 days apart.
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 |
|---|---|---|
| Enterovirus Type 71 Vaccine,Inactivated(Vero Cells),high dose | Experimental | Biological: Enterovirus Type 71 VaccineParticipants received two doses of the vaccine, 28 days apart |
| Enterovirus Type 71 Vaccine,Inactivated(Vero Cells),low dose | Experimental | Biological: Enterovirus Type 71 VaccineParticipants received two doses of the vaccine, 28 days apart |
| Enterovirus Type 71 Vaccine,Inactivated(Human Diploid Cell) | Active comparator | Biological: Enterovirus Type 71 VaccineParticipants received two doses of the vaccine, 28 days apart |
Who may qualify
- Ages
- 6 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6-71 months, valid identification;
- Infants aged 6-11 months should be full-term (37-42 weeks gestation) and have a birth weight (2500g≤ weight ≤4000g);
- The subject's guardian voluntarily consented to the child's participation in the study and signed an informed consent form;
- The subject's guardian had the ability to learn about the study procedure and was able to participate in all planned follow-ups;
- Pre-enrollment axillary body temperature < 37.5°C.
Key exclusion criteria (16 listed)
- Have received any previous HFMD vaccine;
- Previous history of hand, foot and mouth disease；
- History of allergies to any component of the study vaccine or substances used in the preparation process，or a history of severe adverse effects of vaccine/drug；
- Have a serious congenital malformation or chronic medical condition that may interfere with the conduct or completion of the study；
- History of seizures, epilepsy, encephalopathy, and psychosis (including family history)；
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 |
|---|---|---|
| Enterovirus Type 71 VaccineParticipants received two doses of the vaccine, 28 days apart | Biological | Enterovirus Type 71 Vaccine,Inactivated(Human Diploid Cell), Enterovirus Type 71 Vaccine,Inactivated(Vero Cells),high dose, Enterovirus Type 71 Vaccine,Inactivated(Vero Cells),low dose |
Primary outcome
Anti-EV71 serum neutralizing antibody positive conversion rate at 28 days after immunization
Time frame: 28 days after two doses of vaccination
to evaluate immunogenicity of Enterovirus Type 71 Vaccine
Geometric mean titer (GMT) and growth factor of anti-EV71 serum neutralizing antibody 28 days after immunization
Time frame: 28 days after two doses of vaccination
to evaluate immunogenicity of Enterovirus Type 71 Vaccine
Ratio of subjects with anti-EV71 serum neutralizing antibody titer ≥ 1:8 28 days after immunization
Time frame: 28 days after two doses of vaccination
to evaluate immunogenicity of Enterovirus Type 71 Vaccine
Adverse events within 0-28 days after each dose of vaccination
Time frame: 28 days after each dose of vaccination
to evaluate Safety of Enterovirus Type 71 Vaccine
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 5 Jul 2023.
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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.
Du lin, master 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 2 study testing Enterovirus Type 71 Vaccine 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 5 inclusion and 16 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 5 Jul 2023. 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?
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?
Anti-EV71 serum neutralizing antibody positive conversion rate at 28 days after immunization (time frame: 28 days after two doses of vaccination). The study lists 4 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 Jul 2023.