Enterovirus 71 Inactivated VaccinePhase 4NCT03519568
Clinical Study on Combined Immune Effect of EV71 Inactivated Vaccine
A Phase 4 study testing EV71 (inoculation vaccine) in people with Enterovirus 71 Inactivated Vaccine and HFMD, run by Shandong Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
Background: To prevent and control the epidemic of HFMD and related diseases caused by EV71 infection, the development of EV71 vaccine has been developed in many countries or regions. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Enterovirus 71 Inactivated Vaccine, HFMD
- What is being tested?
- EV71 (inoculation vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,944 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2018to Apr 2019
- 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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged ≥ 6 months
- sign the informed consent form
- the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
- the subjects have completed the basic immunization of 2 needle recombinant hepatitis B vaccine, there is no inoculation history of EV71 vaccine, and no history of EV71 infection
- the last vaccination intervals ≥ 14 days
- temperature ≤ 37℃
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- Inclusion criteria for group Ⅱ（MPSV-A:1+EV71）were as follows:
- aged ≥ 6 months
- sign the informed consent form
- the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
- there is no inoculation history of EV71 vaccine, and there is no history of EV71 infection
- the last vaccination intervals ≥ 14 days
- temperature ≤ 37℃
- aged ≥ 8 months
- sign the informed consent form
- the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
- there is no inoculation history of EV71 vaccine, and there is no history of EV71 infection
- the last vaccination intervals ≥ 14 days and the last attenuated live vaccine intervals≥28days
- temperature ≤ 37℃
- aged ≥ 8 months
- sign the informed consent form
- the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
- there is no inoculation history of EV71 vaccine, and there is no history of EV71 infection
- the last vaccination intervals ≥ 14 days and the last attenuated live vaccine intervals ≥ 28 days
- temperature ≤ 37℃
Who cannot join
- the history or family history of anaphylaxis, convulsion, epilepsy, encephalopathy and psychosis
- the history of severe inoculation allergies
- patients with immunodeficiency and malignant tumors during the treatment period, receiving immunosuppressive therapy (oral steroid) or HIV due to low immunity, or family members have congenital immune disease
- Nonspecific immunoglobulin was injected within one month
- temperature≥37.1℃ and infectious diseases
- the history of thrombocytopenia or other thrombocytopenia with a definite diagnosis
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- respiratory disease, acute infection or chronic disease activity period
- severe cardiovascular disease, liver and kidney disease, and complications of diabetes
- infectious, suppurative and allergic dermatosis
- other conditions that may affect the evaluation of the trail
- any serious adverse events that have a causal relationship with the inoculation of the upper dose of the vaccine
- the abnormality of 4 levels (local, systemic adverse reactions and vital signs) was judged to be related to vaccination
- other new standards of exclusion criteria for first needle
- other conditions that may affect the evaluation of the trail
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Center for Disease Control and Prevention
Jinan, Shandong
Qing Xu, 86-531-82679623, sdcdc@vip.163.com
About this study
Official title: Evaluating Immunogenicity and Safety Effect on Combined Immune Effect of EV71 Inactivated Vaccine and HepB、MPSV-A、MR、JE-L：A Multi-center Randomized Controlled Trial
Background: To prevent and control the epidemic of HFMD and related diseases caused by EV71 infection, the development of EV71 vaccine has been developed in many countries or regions. According to the requirements of drug registration approval, we need to evaluate immunogenicity and safety effect on combined immune effect of EV71 inactivated vaccine and other vaccines (HepB、MPSV-A、MR、JE-L).
Method: Four experimental groups (HepB:3+EV71, MPSV-A:1+EV71, MR+EV71, JE-L+EV71) were included in this clinical trail. In addition to the meningococcal vaccine research group, the other three groups were followed up for the 4 times. The initial blood samples were collected, and the first dose vaccine was inoculated at the same time. EV71 second doses of vaccine were inoculated at 30 day, the blood was collected after 30 days of immunization with second doses. 6 months of safety follow-up was carried out in the whole clinical trial after vaccination. The meningococcal vaccine research group increased 1 follow-up after the second dose of MPSV-A vaccine. The index of immunogenicity and safety effect in four experimental groups need to be evaluated.
Read the detailed description
Study design and participants The study was conducted in four provinces (Shandong, Shanxi, Shaanxi and Hunan) of China, which contains Haiyang city, Rushan city, Shimen County, Chen Cang District, Qishan County, Taigu County and Qi County. 6/8 months children were recruited in this study, individuals were randomly assigned to experimental group and control group. Demographic information (age, sex, height and weight) was made and blood samples were collected for each individual in the same way.
Vaccine inoculation and follow-up
TestⅠ(HepB:3+EV71):
Experimental group - 6 month old HepB third dose and EV71 first dose were inoculated at the same time, 7 month old EV71 second dose was inoculated, blood samples from the participants were collected at 8 month old; Control group 1- 6 month old HepB third dose was inoculated separately, blood samples from the participants were collected after two months; Control group 2 - 6 month old EV71 first doses was inoculated, 7 month old EV71 second dose was inoculated, blood samples from the participants were collected at 8 month old.
TestⅡ(MPSV-A:1+EV71):
Experimental group - 6 month old MPSV-A first dose and EV71 first dose were inoculated at the same time, 7 month old EV71 second dose was inoculated, 9 month old MPSV-A second dose was inoculated, blood samples from the participants were collected at 10 month old; Control group 1- 6 month old MPSV-A first dose was inoculated separately, 9 month old MPSV-A second dose was inoculated separately, blood samples from the participants were collected at 10 month old; Control group 2 - 6 month old EV71 first doses was inoculated, 7 month old EV71 second dose was inoculated, blood samples from the participants were collected at 10 month old.
TestⅢ (MR+EV71):
Experimental group - 8 month old MR first dose and EV71 first dose were inoculated at the same time, 9 month old EV71 second dose was inoculated, blood samples from the participants were collected at 10 month old.
Control group 1- 8 month old MR first dose was inoculated separately, blood samples from the participants were collected at 10 month old; Control group 2 - 8 month old EV71 first doses was inoculated, 9 month old EV71 second dose was inoculated, blood samples from the participants were collected at 10 month old.
TestⅣ(JE-L+EV71):
Experimental group - 8 month old JE-L first dose and EV71 first dose were inoculated at the same time, 9 month old EV71 second dose was inoculated, blood samples from the participants were collected at 10 month old.
Control group 1- 8month old JE-L first dose was inoculated separately, blood samples from the participants were collected at 10 month old; Control group 2 - 8 month old EV71 first doses was inoculated, 9 month old EV71 second dose was inoculated, blood samples from the participants were collected at 10 month old.
EV71 vaccine 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China; 10μg HepB 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China; 30ug MPSV-A 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China; MR 0.5ml per dose, Beijiing Biological Products Co., Ltd., Beijing, China; JE-L 0.5ml per dose, Chengdu Biological Products Co., Ltd., Chengdu,Sichuan Province, China Immunogenicity end point Detection of serum antibody EV71 vaccine by culture neutralization test, the definition of positive for neutralizing antibody titers of <1:8 before inoculation, inoculation after neutralizing antibody titers than 1:8; or before inoculation neutralizing antibody titer is above 1:8, the titer of neutralizing antibody after vaccination appeared more than 4 times the growth.
Hepatitis B vaccine seroconversion was defined as Anti-HBs<10mIU/ml before inoculation, Anti-HBs after inoculation was more than 10mIU/ml.
Leprosy vaccine using measles rubella immunoglobulin ELISA detection test, measles >200U/ml positive for rubella >20U/ml positive or positive before inoculation; after inoculation, antibody positive growth is more than 4 times.
Japanese encephalitis vaccine serum samples by using PRNT test before immunization antibody titer after inoculation was less than 1:5, at 1:10, or after vaccination antibody titer than before inoculation is no less than 4 times of growth is positive.
Meningococcal vaccine samples A meningococcal bactericidal antibody level in serum by micro bactericidal antibody test, the antibody titer after inoculation than before inoculation is no less than 4 times of growth is positive.
Safety assessment Safety assessment Participants were provided with diary cards to record the occurrence and severity of solicited local reactions at the injection site (pain, induration, erythema, edema, pruritus) during 7 days after vaccination, solicited systemic reactions (fever, headache, fatigued, cough, myalgia, asthenia, vertigo, diarrhea), and any unsolicited adverse during 29 days after vaccination.
Statistical analyses The quantitative index lists the standard deviation, the median, the maximum and the minimum, and the qualitative index or the grade index list the frequency distribution table. The antibody titers of immunogenicity index should be represented by geometric mean, median, maximum and minimum value and 95% confidence interval. The antibody titer should be analyzed by logarithmic transformation.
A list of the total population, susceptible and non susceptible seroconversion rate and 95% confidence interval, and calculation (test group and control group) rate difference and 95% confidence interval, non-inferiority test; the test group and the control group between the antibody geometric mean (GMT/GMC) compared with the t test after logarithmic transformation P, with less than 0.05 as there were statistically significant differences in the standard
- Conditions
- Enterovirus 71 Inactivated Vaccine, HFMD
- Being tested
- EV71 (inoculation vaccine)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV71 (inoculation vaccine)Biological
EV71 vaccine 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 10μg HepB 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 30ug MPSV-A 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China MR 0.5ml per dose, Beijiing Biological Products Co., Ltd., Beijing, China JE-L 0.5ml per dose, Chengdu Biological Products Co., Ltd., Chengdu,Sichuan Province, China
| Study group | Role | What they receive |
|---|---|---|
| Combination inoculation group | Experimental | GroupⅠ: HepB:3 and EV71 were injected at 6 months old, EV71 second dose was injected at 7 months old GroupⅡ: MPSV-A:1 and EV71 were injected at 6 months old, EV71 second dose was injected at 7 months old, MPSV-A:1 second dose was injected at 9 months old GroupⅢ: MR and EV71 were injected at 8 months old, EV71 second dose was injected at 9 months old GroupⅣ: JE-Land EV71 were injected at 8 months old, EV71 second dose was injected at 9 months old Receives: Biological: EV71 (inoculation vaccine) |
| Separate inoculation control group | Active comparator | GroupⅠ: HepB:3 third dose was injected at 6 months old GroupⅡ: MPSV-A:1 was injected at 6 months old, then MPSV-A:1 second dose was injected at 9 months old GroupⅢ: MR was injected at 8 months old GroupⅣ: JE-L was injected at 8 months old Receives: Biological: EV71 (inoculation vaccine) |
| EV71 inoculation control group | Active comparator | GroupⅠ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old GroupⅡ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old GroupⅢ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old GroupⅣ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old Receives: Biological: EV71 (inoculation vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody positive rate to vaccinations
The definition of EV71 vaccine positive for antibody titers <1:8 before inoculation, antibody titers ≥ 1:8 after inoculation; or before inoculation antibody titer is above 1:8,the titer after vaccination appeared more than 4 times growth.Hepatitis B vaccine seroconversion was defined as Anti-HBs<10mIU/ml before inoculation, Anti-HBs after inoculation was more than 10mIU/ml.Leprosy vaccine using ELISA detection test, measles >200U/ml positive for rubella >20U/ml positive or positive before inoculation, antibody positive growth is more than 4 times.Japanese encephalitis vaccine using PRNT test before immunization antibody titer after inoculation was less than 1:5, at 1:10, or after vaccination antibody titer than before inoculation is no less than 4 times of growth is positive. A meningococcal bactericidal antibody level in serum by micro bactericidal antibody test, the antibody titer after inoculation than before inoculation is more than 4 times growth is positive.
Measured: within 90 days after the last vaccination
Antibody titer / concentration to vaccination
Blood samples from the participants were collected before and after vaccination, the changes of serum concentration and titer were determined by serum test.
Measured: within 90 days after the last vaccination
Secondary outcomes (1)
Number of Participants at the Injection Site, Solicited Systemic Reactions, or Any Unsolicited Adverse Events
Participants were provided with diary cards to record the occurrence and severity of solicited local reactions at the injection site (pain, induration, erythema, edema, pruritus) during 7 days after vaccination, solicited systemic reactions (fever, headache, fatigued, cough, myalgia, asthenia, vertigo, diarrhea), and any unsolicited adverse during 29 days after vaccination.
Measured: within 90 days after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start1 Mar 2018
- Primary completionDec 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enterovirus 71 Inactivated VaccineStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,944 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Province Centers for Disease Control and Prevention
- Sponsor type
- University, hospital or other
- Collaborators
- Hunan Provincial Center for Disease Control and Prevention, Shaanxi Provincial Center for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519568
- Sponsor's protocol ID
- ShandongCDCP
- Status last verified
- Apr 2018
- First submitted
- 25 Mar 2018
- Last updated
- 9 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu X, Chang S, Wang R, Xiao Y, Li F, Xu Q, Zhang S, Chen X, Zhang S, Zhang M, Chen X, Cao Q, Liu X, Wang H, Zhan D, Chen H, Chen W, Jiang J, Zhang C, Wang H, Gao L, Shi X, Yang X, Xu A. Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China. Vaccines (Basel). 2022 Jun 2;10(6):895. doi: 10.3390/vaccines10060895.
PubMed 35746502
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Immunogenicity and Safety Effect on Combined Immune Effect of EV71 Inactivated Vaccine and HepB、MPSV-A、MR、JE-L：A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03519568
- Acronym / sponsor ID
- ShandongCDCP
- Conditions
- Enterovirus 71 Inactivated Vaccine, HFMD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,944 participants (estimated)
- Lead sponsor
- Shandong Province Centers for Disease Control and PreventionUniversity, hospital or other
- Collaborators
- Hunan Provincial Center for Disease Control and Prevention, Shaanxi Provincial Center for Disease Control and Prevention
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 9 May 2018 (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.
Background: To prevent and control the epidemic of HFMD and related diseases caused by EV71 infection, the development of EV71 vaccine has been developed in many countries or regions. According to the requirements of drug registration approval, we need to evaluate immunogenicity and safety effect on combined immune effect of EV71 inactivated vaccine and other vaccines (HepB、MPSV-A、MR、JE-L).
Method: Four experimental groups (HepB:3+EV71, MPSV-A:1+EV71, MR+EV71, JE-L+EV71) were included in this clinical trail. In addition to the meningococcal vaccine research group, the other three groups were followed up for the 4 times. The initial blood samples were collected, and the first dose vaccine was inoculated at the same time. EV71 second doses of vaccine were inoculated at 30 day, the blood was collected after 30 days of immunization with second doses. 6 months of safety follow-up was carried out in the whole clinical trial after vaccination. The meningococcal vaccine research group increased 1 follow-up after the second dose of MPSV-A vaccine. The index of immunogenicity and safety effect in four experimental groups need to be evaluated.
Detailed description
Study design and participants The study was conducted in four provinces (Shandong, Shanxi, Shaanxi and Hunan) of China, which contains Haiyang city, Rushan city, Shimen County, Chen Cang District, Qishan County, Taigu County and Qi County. 6/8 months children were recruited in this study, individuals were randomly assigned to experimental group and control group. Demographic information (age, sex, height and weight) was made and blood samples were collected for each individual in the same way.
Vaccine inoculation and follow-up
TestⅠ(HepB:3+EV71):
Experimental group - 6 month old HepB third dose and EV71 first dose were inoculated at the same time, 7 month old EV71 second dose was inoculated, blood samples from the participants were collected at 8 month old; Control group 1- 6 month old HepB third dose was inoculated separately, blood samples from the participants were collected after two months; Control group 2 - 6 month old EV71 first doses was inoculated, 7 month old EV71 second dose was inoculated, blood samples from the participants were collected at 8 month old.
TestⅡ(MPSV-A:1+EV71):
Experimental group - 6 month old MPSV-A first dose and EV71 first dose were inoculated at the same time, 7 month old EV71 second dose was inoculated, 9 month old MPSV-A second dose was inoculated, blood samples from the participants were collected at 10 month old; Control group 1- 6 month old MPSV-A first dose was inoculated separately, 9 month old MPSV-A second dose was inoculated separately, blood samples from the participants were collected at 10 month old; Control group 2 - 6 month old EV71 first doses was inoculated, 7 month old EV71 second dose was inoculated, blood samples from the participants were collected at 10 month old.
TestⅢ (MR+EV71):
Experimental group - 8 month old MR first dose and EV71 first dose were inoculated at the same time, 9 month old EV71 second dose was inoculated, blood samples from the participants were collected at 10 month old.
Control group 1- 8 month old MR first dose was inoculated separately, blood samples from the participants were collected at 10 month old; Control group 2 - 8 month old EV71 first doses was inoculated, 9 month old EV71 second dose was inoculated, blood samples from the participants were collected at 10 month old.
TestⅣ(JE-L+EV71):
Experimental group - 8 month old JE-L first dose and EV71 first dose were inoculated at the same time, 9 month old EV71 second dose was inoculated, blood samples from the participants were collected at 10 month old.
Control group 1- 8month old JE-L first dose was inoculated separately, blood samples from the participants were collected at 10 month old; Control group 2 - 8 month old EV71 first doses was inoculated, 9 month old EV71 second dose was inoculated, blood samples from the participants were collected at 10 month old.
EV71 vaccine 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China; 10μg HepB 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China; 30ug MPSV-A 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China; MR 0.5ml per dose, Beijiing Biological Products Co., Ltd., Beijing, China; JE-L 0.5ml per dose, Chengdu Biological Products Co., Ltd., Chengdu,Sichuan Province, China Immunogenicity end point Detection of serum antibody EV71 vaccine by culture neutralization test, the definition of positive for neutralizing antibody titers of <1:8 before inoculation, inoculation after neutralizing antibody titers than 1:8; or before inoculation neutralizing antibody titer is above 1:8, the titer of neutralizing antibody after vaccination appeared more than 4 times the growth.
Hepatitis B vaccine seroconversion was defined as Anti-HBs<10mIU/ml before inoculation, Anti-HBs after inoculation was more than 10mIU/ml.
Leprosy vaccine using measles rubella immunoglobulin ELISA detection test, measles >200U/ml positive for rubella >20U/ml positive or positive before inoculation; after inoculation, antibody positive growth is more than 4 times.
Japanese encephalitis vaccine serum samples by using PRNT test before immunization antibody titer after inoculation was less than 1:5, at 1:10, or after vaccination antibody titer than before inoculation is no less than 4 times of growth is positive.
Meningococcal vaccine samples A meningococcal bactericidal antibody level in serum by micro bactericidal antibody test, the antibody titer after inoculation than before inoculation is no less than 4 times of growth is positive.
Safety assessment Safety assessment Participants were provided with diary cards to record the occurrence and severity of solicited local reactions at the injection site (pain, induration, erythema, edema, pruritus) during 7 days after vaccination, solicited systemic reactions (fever, headache, fatigued, cough, myalgia, asthenia, vertigo, diarrhea), and any unsolicited adverse during 29 days after vaccination.
Statistical analyses The quantitative index lists the standard deviation, the median, the maximum and the minimum, and the qualitative index or the grade index list the frequency distribution table. The antibody titers of immunogenicity index should be represented by geometric mean, median, maximum and minimum value and 95% confidence interval. The antibody titer should be analyzed by logarithmic transformation.
A list of the total population, susceptible and non susceptible seroconversion rate and 95% confidence interval, and calculation (test group and control group) rate difference and 95% confidence interval, non-inferiority test; the test group and the control group between the antibody geometric mean (GMT/GMC) compared with the t test after logarithmic transformation P, with less than 0.05 as there were statistically significant differences in the standard
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination inoculation group | Experimental | Biological: EV71 (inoculation vaccine)GroupⅠ: HepB:3 and EV71 were injected at 6 months old, EV71 second dose was injected at 7 months old GroupⅡ: MPSV-A:1 and EV71 were injected at 6 months old, EV71 second dose was injected at 7 months old, MPSV-A:1 second dose was injected at 9 months old GroupⅢ: MR and EV71 were injected at 8 months old, EV71 second dose was injected at 9 months old GroupⅣ: JE-Land EV71 were injected at 8 months old, EV71 second dose was injected at 9 months old |
| Separate inoculation control group | Active comparator | Biological: EV71 (inoculation vaccine)GroupⅠ: HepB:3 third dose was injected at 6 months old GroupⅡ: MPSV-A:1 was injected at 6 months old, then MPSV-A:1 second dose was injected at 9 months old GroupⅢ: MR was injected at 8 months old GroupⅣ: JE-L was injected at 8 months old |
| EV71 inoculation control group | Active comparator | Biological: EV71 (inoculation vaccine)GroupⅠ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old GroupⅡ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old GroupⅢ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old GroupⅣ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (25 listed)
- aged ≥ 6 months
- sign the informed consent form
- the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
- the subjects have completed the basic immunization of 2 needle recombinant hepatitis B vaccine, there is no inoculation history of EV71 vaccine, and no history of EV71 infection
- the last vaccination intervals ≥ 14 days
Key exclusion criteria (14 listed)
- the history or family history of anaphylaxis, convulsion, epilepsy, encephalopathy and psychosis
- the history of severe inoculation allergies
- patients with immunodeficiency and malignant tumors during the treatment period, receiving immunosuppressive therapy (oral steroid) or HIV due to low immunity, or family members have congenital immune disease
- Nonspecific immunoglobulin was injected within one month
- temperature≥37.1℃ and infectious diseases
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 |
|---|---|---|
| EV71 (inoculation vaccine)EV71 vaccine 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 10μg HepB 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 30ug MPSV-A 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China MR 0.5ml per dose, Beijiing Biological Products Co., Ltd., Beijing, China JE-L 0.5ml per dose, Chengdu Biological Products Co., Ltd., Chengdu,Sichuan Province, China | Biological | Combination inoculation group, EV71 inoculation control group, Separate inoculation control group |
Primary outcome
Antibody positive rate to vaccinations
Time frame: within 90 days after the last vaccination
The definition of EV71 vaccine positive for antibody titers <1:8 before inoculation, antibody titers ≥ 1:8 after inoculation; or before inoculation antibody titer is above 1:8,the titer after vaccination appeared more than 4 times growth.Hepatitis B vaccine seroconversion was defined as Anti-HBs<10mIU/ml before inoculation, Anti-HBs after inoculation was more than 10mIU/ml.Leprosy vaccine using ELISA detection test, measles >200U/ml positive for rubella >20U/ml positive or positive before inoculation, antibody positive growth is more than 4 times.Japanese encephalitis vaccine using PRNT test before immunization antibody titer after inoculation was less than 1:5, at 1:10, or after vaccination antibody titer than before inoculation is no less than 4 times of growth is positive. A meningococcal bactericidal antibody level in serum by micro bactericidal antibody test, the antibody titer after inoculation than before inoculation is more than 4 times growth is positive.
Antibody titer / concentration to vaccination
Time frame: within 90 days after the last vaccination
Blood samples from the participants were collected before and after vaccination, the changes of serum concentration and titer were determined by serum test.
1 secondary outcome
Number of Participants at the Injection Site, Solicited Systemic Reactions, or Any Unsolicited Adverse Events
Time frame: within 90 days after the last vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Derived from this study: PubMed 35746502Liu X, Chang S, Wang R, Xiao Y, Li F, Xu Q, Zhang S, Chen X, Zhang S, Zhang M, Chen X, Cao Q, Liu X, Wang H, Zhan D, Chen H, Chen W, Jiang J, Zhang C, Wang H, Gao L, Shi X, Yang X, Xu A. Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China. Vaccines (Basel). 2022 Jun 2;10(6):895. doi: 10.3390/vaccines10060895.
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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.
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 EV71 (inoculation vaccine) in people with Enterovirus 71 Inactivated Vaccine and HFMD, run by Shandong 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 25 inclusion and 14 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 9 May 2018. 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?
Contact Qing Xu (86-531-82679623, sdcdc@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody positive rate to vaccinations (time frame: within 90 days after the last 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?
On the ClinicalTrials.gov record for NCT03519568, which also lists 1 linked publication.
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 9 May 2018.