Hand, Foot and Mouth DiseasePhase 4NCT06209398
Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine
A Phase 4 study testing Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ), Recombinant Hepatitis B Vaccine and Group A meningococcal polysaccharide vaccine in people with Hand, Foot and Mouth Disease, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the immunogenicity and safety of inactivated enterovirus type 71 vaccine combined with recombinant hepatitis B vaccine or Group a meningococcal polysaccharide vaccine. Read more about this study
- Who is it for?
- Ages 6 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ), Recombinant Hepatitis B Vaccine and Group A meningococcal polysaccharide vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2018to 31 Dec 2025
- Phase
- Phase 4
- 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 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 6-7 months with no history of vaccination within the past month and normal intelligence.
- Healthy individuals determined by researchers after inquiring about medical history and physical examination.
- The recipients are able to comply with the requirements of the research protocol and undergo immunogenicity testing.
- Individuals without contraindications.
- Underarm temperature ≤ 37 ℃.
- Obtain informed consent from the recipient's guardian and sign an informed consent form.
Who cannot join
- Individuals with any serious illness.
- Individuals who are allergic to any ingredient in the research vaccine.
- Individuals with a history of neurological symptoms or signs.
- Individuals with bleeding constitution or prolonged bleeding time.
- Individuals who have had hand, foot, and mouth disease, hepatitis B, and epidemic cerebrospinal meningitis in the past.
- Individuals who have received other vaccines or immunoglobulin injections or any investigational drugs within the past 4 weeks.
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- Infected individuals who have had any acute illness or require systemic antibiotic or antiviral treatment within the past 7 days.
- Individuals who have experienced fever (axillary temperature ≥ 38 ℃) within the past 3 days.
- Participating in another researcher.
- Individuals with a history or family history of allergies, seizures, epilepsy, encephalopathy, and mental illness.
- Patients with thrombocytopenia or other coagulation disorders that may cause contraindications for intramuscular injection.
- Patients with severe chronic diseases.
- Known or suspected concurrent diseases include: respiratory system diseases, acute or chronic disease activity period, HIV infection in the mother or research subject of the child, cardiovascular disease, severe hypertension, malignant tumor treatment period, and skin disease patients.
- Endemic disease patients.
- Those who plan to leave their place of residence before the end of the study.
- Researchers believe that any situation that may affect observation and evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Province Centers for Disease Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: Study on the Immunogenicity and Safety of Inactivated Enterovirus Type 71 Vaccine Combined Administration With Recombinant Hepatitis B and Group A Meningococcal Vaccine
The main purpose of this study is to evaluate the immunogenicity and safety of inactivated enterovirus type 71 vaccine combined with recombinant hepatitis B vaccine or Group a meningococcal polysaccharide vaccine.
Read the detailed description
This study conducts a randomized, controlled design, enrolled infants over 6 months old as the participant, and setting up three parallel groups. Participants are randomly assigned to three groups. The first group is the inactivated enterovirus type 71 Vaccine (EV71 vaccine), Recombinant hepatitis B vaccine and Group A meningococcal polysaccharide vaccine combined administration group. The first dose of inactivated EV71 vaccine and Recombinant hepatitis B vaccine are combined administration on day 0, and the second dose of inactivated EV71 vaccine and Group A meningococcal polysaccharide vaccine are combined administration on day 30. The second group is the inactivated EV71 vaccine single administration group, with two doses of inactivated EV71 vaccine administered on day 0 and day 30 respectively. The third group is Recombinant hepatitis B vaccine and Group A meningococcal polysaccharide vaccine administration group, the Recombinant hepatitis B vaccine is administered on day 0, and the Group A meningococcal polysaccharide vaccine is administered on day 30. Each participant will be followed up 30 minutes, 24 hours, 48 hours, and 72 hours after each vaccination actively, and will be reported for 4-30 days to collect adverse reactions/events passively. All participants collect serum samples before administration (day 0) and second dose of administration (day 30), 30 days and 1 year after full-term administration (day 60 and 1 year). The serum samples of participants will be collected 5 years after full-term administration at the first and second group. The immunogenicity of the inactivated EV71 vaccine, Recombinant hepatitis B vaccine, and Group A meningococcal polysaccharide vaccine of three groups participants will be detected and analyzed.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ), Recombinant Hepatitis B Vaccine, Group A meningococcal polysaccharide vaccine
- Medical subject headings
- Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell )Biological
Used for EV71 virus susceptible individuals aged 6 months to 5 years. Each bottle (bottle) contains 0.5ml of neutralizing antibody with a potency of no less than 3.0EU for the inactivated 71 type intestinal disease vaccine. Intramuscular injection into the deltoid muscle of the upper arm. The immunization program consists of 2 doses with 1-month interval.
Recombinant Hepatitis B VaccineBiological
Each vaccine bottle (tube) is 0.5ml, containing 10ug of HBsAg and inject into the upper deltoid muscle. The immunization program consists of three doses, administered at 0, 1, and 6 months respectively. Newborns are given the first dose within 24 hours after birth, with one dose of vaccine administered each time.
Group A meningococcal polysaccharide vaccineBiological
This product is made by lyophilizing the purified polysaccharide antigen obtained from Group A meningococcus liquid culture. The vaccination targets children aged 6 months to 15 years old, and the initial immunization age starts from 6 months old. Infants and young children aged 6 to 12 months old are vaccinated with 2 doses of 30 micrograms, with an interval of 3 months. Subcutaneously inject 0.5ml into the lateral deltoid muscle of the upper arm at a dose of 30 μg of polysaccharide antigen (0.5ml).
| Study group | Role | What they receive |
|---|---|---|
| Combined immunization Group | Experimental | The first dose of inactivated EV71 vaccine and the third dose of hepatitis B vaccine were combined administered on day 0, and the second dose of EV71 vaccine and Group A meningococcal polysaccharide vaccine were jointly administered on day 30. Receives: Biological: Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ); Biological: Recombinant Hepatitis B Vaccine; Biological: Group A meningococcal polysaccharide vaccine |
| Single immunization Group | Active comparator | On the 0th and 30th day, receive two doses of inactivated EV71 vaccine respectively. On the 60th day, both hepatitis B vaccine and Group A meningococcal polysaccharide vaccine were administrated. Receives: Biological: Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ) |
| hepatitis B and Group A meningococcal polysaccharide vaccine Group | Active comparator | Administrate hepatitis B vaccine on day 0, and Group A meningococcal polysaccharide vaccine on day 30. Receives: Biological: Recombinant Hepatitis B Vaccine; Biological: Group A meningococcal polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of inactived Enterovirus type 71 Vaccine Combined With Hepatitis B andGroup A meningococcal polysaccharide vaccine
To analyze the immunogenicity after inactived EV71 vaccine, hepatitis B vaccine, Group A meningococcal polysaccharide vaccine were adminisataed after combined use and single vaccination
Measured: 1 month, 1 years and 5 years after full term immunization.
Safety of Enterovirus type 71 Vaccine Combined With Hepatitis B and Group A meningococcal polysaccharide vaccine
To compare the adverse reactions of inactived EV71 vaccine, hepatitis B vaccine and Group A meningococcal polysaccharide vaccine after combined use and single vaccination.
Measured: 30 minutes, 24 hours, 48 hours, and 72 hours of active follow-up, with passive reporting for 4-30 days。
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start24 May 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth DiseaseStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 510 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209398
- Sponsor's protocol ID
- JSEPI-005
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Immunogenicity and Safety of Inactivated Enterovirus Type 71 Vaccine Combined Administration With Recombinant Hepatitis B and Group A Meningococcal Vaccine
- ClinicalTrials.gov ID
- NCT06209398
- Acronym / sponsor ID
- JSEPI-005
- Conditions
- Hand, Foot and Mouth Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Institute of Medical Biology, Chinese Academy of Medical Sciences
- Study start
- 24 May 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jan 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 main purpose of this study is to evaluate the immunogenicity and safety of inactivated enterovirus type 71 vaccine combined with recombinant hepatitis B vaccine or Group a meningococcal polysaccharide vaccine.
Detailed description
This study conducts a randomized, controlled design, enrolled infants over 6 months old as the participant, and setting up three parallel groups. Participants are randomly assigned to three groups. The first group is the inactivated enterovirus type 71 Vaccine (EV71 vaccine), Recombinant hepatitis B vaccine and Group A meningococcal polysaccharide vaccine combined administration group. The first dose of inactivated EV71 vaccine and Recombinant hepatitis B vaccine are combined administration on day 0, and the second dose of inactivated EV71 vaccine and Group A meningococcal polysaccharide vaccine are combined administration on day 30. The second group is the inactivated EV71 vaccine single administration group, with two doses of inactivated EV71 vaccine administered on day 0 and day 30 respectively. The third group is Recombinant hepatitis B vaccine and Group A meningococcal polysaccharide vaccine administration group, the Recombinant hepatitis B vaccine is administered on day 0, and the Group A meningococcal polysaccharide vaccine is administered on day 30. Each participant will be followed up 30 minutes, 24 hours, 48 hours, and 72 hours after each vaccination actively, and will be reported for 4-30 days to collect adverse reactions/events passively. All participants collect serum samples before administration (day 0) and second dose of administration (day 30), 30 days and 1 year after full-term administration (day 60 and 1 year). The serum samples of participants will be collected 5 years after full-term administration at the first and second group. The immunogenicity of the inactivated EV71 vaccine, Recombinant hepatitis B vaccine, and Group A meningococcal polysaccharide vaccine of three groups participants will be detected and analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined immunization Group | Experimental | Biological: Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ), Biological: Recombinant Hepatitis B Vaccine, Biological: Group A meningococcal polysaccharide vaccineThe first dose of inactivated EV71 vaccine and the third dose of hepatitis B vaccine were combined administered on day 0, and the second dose of EV71 vaccine and Group A meningococcal polysaccharide vaccine were jointly administered on day 30. |
| Single immunization Group | Active comparator | Biological: Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell )On the 0th and 30th day, receive two doses of inactivated EV71 vaccine respectively. On the 60th day, both hepatitis B vaccine and Group A meningococcal polysaccharide vaccine were administrated. |
| hepatitis B and Group A meningococcal polysaccharide vaccine Group | Active comparator | Biological: Recombinant Hepatitis B Vaccine, Biological: Group A meningococcal polysaccharide vaccineAdministrate hepatitis B vaccine on day 0, and Group A meningococcal polysaccharide vaccine on day 30. |
Who may qualify
- Ages
- 6 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy children aged 6-7 months with no history of vaccination within the past month and normal intelligence.
- Healthy individuals determined by researchers after inquiring about medical history and physical examination.
- The recipients are able to comply with the requirements of the research protocol and undergo immunogenicity testing.
- Individuals without contraindications.
- Underarm temperature ≤ 37 ℃.
Key exclusion criteria (16 listed)
- Individuals with any serious illness.
- Individuals who are allergic to any ingredient in the research vaccine.
- Individuals with a history of neurological symptoms or signs.
- Individuals with bleeding constitution or prolonged bleeding time.
- Individuals who have had hand, foot, and mouth disease, hepatitis B, and epidemic cerebrospinal meningitis in the past.
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 Vaccine, inactivated ( Human Diploid Cell )Used for EV71 virus susceptible individuals aged 6 months to 5 years. Each bottle (bottle) contains 0.5ml of neutralizing antibody with a potency of no less than 3.0EU for the inactivated 71 type intestinal disease vaccine. Intramuscular injection into the deltoid muscle of the upper arm. The immunization program consists of 2 doses with 1-month interval. | Biological | Combined immunization Group, Single immunization Group |
| Recombinant Hepatitis B VaccineEach vaccine bottle (tube) is 0.5ml, containing 10ug of HBsAg and inject into the upper deltoid muscle. The immunization program consists of three doses, administered at 0, 1, and 6 months respectively. Newborns are given the first dose within 24 hours after birth, with one dose of vaccine administered each time. | Biological | Combined immunization Group, hepatitis B and Group A meningococcal polysaccharide vaccine Group |
| Group A meningococcal polysaccharide vaccineThis product is made by lyophilizing the purified polysaccharide antigen obtained from Group A meningococcus liquid culture. The vaccination targets children aged 6 months to 15 years old, and the initial immunization age starts from 6 months old. Infants and young children aged 6 to 12 months old are vaccinated with 2 doses of 30 micrograms, with an interval of 3 months. Subcutaneously inject 0.5ml into the lateral deltoid muscle of the upper arm at a dose of 30 μg of polysaccharide antigen (0.5ml). | Biological | Combined immunization Group, hepatitis B and Group A meningococcal polysaccharide vaccine Group |
Primary outcome
Immunogenicity of inactived Enterovirus type 71 Vaccine Combined With Hepatitis B andGroup A meningococcal polysaccharide vaccine
Time frame: 1 month, 1 years and 5 years after full term immunization.
To analyze the immunogenicity after inactived EV71 vaccine, hepatitis B vaccine, Group A meningococcal polysaccharide vaccine were adminisataed after combined use and single vaccination
Safety of Enterovirus type 71 Vaccine Combined With Hepatitis B and Group A meningococcal polysaccharide vaccine
Time frame: 30 minutes, 24 hours, 48 hours, and 72 hours of active follow-up, with passive reporting for 4-30 days。
To compare the adverse reactions of inactived EV71 vaccine, hepatitis B vaccine and Group A meningococcal polysaccharide vaccine after combined use and single vaccination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
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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 4 study testing Enterovirus Type 71 Vaccine, inactivated ( Human Diploid Cell ), Recombinant Hepatitis B Vaccine and Group A meningococcal polysaccharide vaccine in people with Hand, Foot and Mouth Disease, run by Jiangsu Province Centers for Disease Control and Prevention 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 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: status not confirmed, as of the sponsor's last update on 17 Jan 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Immunogenicity of inactived Enterovirus type 71 Vaccine Combined With Hepatitis B andGroup A meningococcal polysaccharide vaccine (time frame: 1 month, 1 years and 5 years after full term immunization.). 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 17 Jan 2024.