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The Phase IVd of Inactivated Enterovirus 71 Vaccine

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ClinicalTrials.gov Identifier: NCT03296410
Recruitment Status : Unknown
Verified September 2017 by Qihan Li, Chinese Academy of Medical Sciences.
Recruitment status was:  Enrolling by invitation
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Guangdong Center for Disease Prevention and Control
Information provided by (Responsible Party):
Qihan Li, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE September 1, 2017
First Posted Date  ICMJE September 28, 2017
Last Update Posted Date September 28, 2017
Actual Study Start Date  ICMJE September 14, 2017
Estimated Primary Completion Date September 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Phase IVd of Inactivated Enterovirus 71 Vaccine
Official Title  ICMJE 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)
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hand, Foot and Mouth Disease (HFMD)
Intervention  ICMJE
  • 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.
  • 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.
  • Biological: two measles attenuated live vaccine
    infants vaccined with one dose two measles attenuated live vaccine at 8 months old.
  • Biological: live attenuated Japanese encephalitis vaccine
    infants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 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).
Study Arms  ICMJE
  • 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.
    Intervention: Biological: EV71 and two measles attenuated live vaccine
  • 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.
    Intervention: Biological: EV71 and attenuated Japanese encephalitis vaccine
  • Active Comparator: two measles attenuated live vaccine
    infants vaccinated with two measles attenuated live vaccine at 8 months old
    Intervention: Biological: two measles attenuated live vaccine
  • Active Comparator: live attenuated Japanese encephalitis vaccine
    infants vaccinated with live attenuated Japanese encephalitis vaccine at 8 months old
    Intervention: Biological: live attenuated Japanese encephalitis vaccine
  • 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.
    Intervention: Biological: EV71 vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 27, 2017)
1220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2, 2019
Estimated Primary Completion Date September 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Months to 9 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03296410
Other Study ID Numbers  ICMJE 20170710
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qihan Li, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Guangdong Center for Disease Prevention and Control
Investigators  ICMJE Not Provided
PRS Account Chinese Academy of Medical Sciences
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP