The Phase IVd of Inactivated Enterovirus 71 Vaccine

September 27, 2017 updated by: Qihan Li, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

The Safety and Immunogenicity of Enterovirus Type 71 Inactivated Vaccine (Human Diploid Cell) With Two Measles Attenuated Live Vaccine and Live Attenuated Japanese Encephalitis Vaccine at the Same Time Point in Infants (8-month-old)

Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage.

Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IVd is to evaluated the immunogenicity and safety of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old) in Guangdong Province, China.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are two parts of phase IVd clinical trials have been performed. First, to evaluate the immunogenicity of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old), within 56-day-post-immunized.

Second, to safety of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old), within 56-day-post-immunized.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 511430
        • Guangdong Province Center for Diseases Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 months to 9 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects (6-71 months old children) as established by medical history and clinical examination
  • The subjects' legal guardian must be aware of this vaccines
  • The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
  • Subjects with temperature ≤ 37.0 ℃
  • The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol
  • Persist for a 14-month visit (and receive blood, stool (or specimens by means of a swab) tests according to program requirements in immunogenicity observation group)

Exclusion Criteria:

  • Allergy or serious side-effects to a vaccine or any ingredient of vaccine
  • Epilepsy, seizures, convulsions, neurological illness
  • Congenital or hereditary immunodeficiency
  • Autoimmune disease
  • Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
  • Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy
  • Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder
  • Acute illness or acute exacerbation of chronic disease in last 7 days
  • Any prior administration of immunodepressant or corticosteroids in last 6 months
  • Any prior administration of blood products in last 3 months
  • Any prior administration of live-attenuated vaccine in last 15 days
  • Any prior administration of subunit or inactivated vaccines in last 7 days
  • Fever before vaccination, axillary temperature ﹥37.0 ℃
  • The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc.
  • Hypertension or hypotension. Systolic blood pressure ﹥140 mmHg and/ or diastolic blood pressure ﹥90 mmHg; systolic blood pressure ﹤90 mmHg and/or diastolic blood pressure ﹤60 mmHg
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
  • take part into other vaccine or drug clinical trials in last half year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: EV71 and two measles attenuated live vaccine
infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and two measles attenuated live vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
Biological: EV71 and two measles attenuated live vaccine
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with two measles attenuated live vaccine at 8 months old.
EXPERIMENTAL: EV71 and attenuated Japanese encephalitis vaccine
infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and live attenuated Japanese encephalitis vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
Biological: EV71 and attenuated Japanese encephalitis vaccine
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with attenuated Japanese encephalitis vaccine at 8 months old.
ACTIVE_COMPARATOR: two measles attenuated live vaccine
infants vaccinated with two measles attenuated live vaccine at 8 months old
Biological: two measles attenuated live vaccine
infants vaccined with one dose two measles attenuated live vaccine at 8 months old.
ACTIVE_COMPARATOR: live attenuated Japanese encephalitis vaccine
infants vaccinated with live attenuated Japanese encephalitis vaccine at 8 months old
Biological: live attenuated Japanese encephalitis vaccine
infants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 months old.
ACTIVE_COMPARATOR: EV71 vaccine
infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
Biological: EV71 vaccine
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination
Time Frame: at 0 day before finishing 1st doses immunization
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-EBV antibodies in serum of children before first vaccination
Time Frame: at 0 day before finishing 1st doses immunization
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-measles virus antibodies in serum of children before first vaccination
Time Frame: at 0 day before finishing 1st doses immunization
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-Rubella virus antibodies in serum of children before first vaccination
Time Frame: at 0 day before finishing 1st doses immunization
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
at 0 day before finishing 1st doses immunization
Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children at 56 days after first vaccination
Time Frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
at 56 days after finishing 1st doses immunization
Evaluate the seroconversion rate of anti-EBV antibodies in serum of children at 56 days after first vaccination
Time Frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
at 56 days after finishing 1st doses immunization
Evaluate the seroconversion rate of anti-measles virus antibodies in serum of children at 56 days after first vaccination
Time Frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
at 56 days after finishing 1st doses immunization
Evaluate the seroconversion rate of anti-Rubella virus antibodies in serum of children at 56 days after first vaccination
Time Frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
at 56 days after finishing 1st doses immunization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate the antibody titers of anti-EV71 antibodies in serum of children
Time Frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-EBV antibodies in serum of children
Time Frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-measles virus antibodies in serum of children
Time Frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-Rubella virus antibodies in serum of children
Time Frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
at 56 days after finishing 1st doses immunization
Incidence of treatment adverse events finishing 1st doses immunization
Time Frame: within 28 days after finishing 1st doses immunization
The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 28 d.p.i. after the 1st injection.
within 28 days after finishing 1st doses immunization
Incidence of treatment adverse events finishing 2nd doses immunization
Time Frame: within 28 days after finishing 2nd doses immunization
The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 28 d.p.i. after injection.
within 28 days after finishing 2nd doses immunization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangdong Center for Disease Prevention and Control

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20170710

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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