The Phase IVd of Inactivated Enterovirus 71 Vaccine

NCT03296410 | Unknown Phase 4 DMC

• 1 other identifier: 20170710
• Study Type: interventional
• Target: 1,220
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand, Foot and Mouth Disease (HFMD)

Keywords

Hand, Foot and Mouth Disease (HFMD); immunogenicity; safety

Outcome Measures

Primary Outcomes (8)

• Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (6)

• Evaluate the antibody titers of anti-EV71 antibodies in serum of children

  at 56 days after finishing 1st doses immunization

• Evaluate the antibody titers of anti-EBV antibodies in serum of children

  at 56 days after finishing 1st doses immunization

• Evaluate the antibody titers of anti-measles virus antibodies in serum of children

  at 56 days after finishing 1st doses immunization

• Evaluate the antibody titers of anti-Rubella virus antibodies in serum of children

  at 56 days after finishing 1st doses immunization

• Incidence of treatment adverse events finishing 1st doses immunization

  within 28 days after finishing 1st doses immunization

Study Arms (5)

EV71 and two measles attenuated live vaccine

EXPERIMENTAL

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

EV71 and attenuated Japanese encephalitis vaccine

EXPERIMENTAL

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

two measles attenuated live vaccine

ACTIVE COMPARATOR

infants vaccinated with two measles attenuated live vaccine at 8 months old

Biological: two measles attenuated live vaccine

live attenuated Japanese encephalitis vaccine

ACTIVE COMPARATOR

infants vaccinated with live attenuated Japanese encephalitis vaccine at 8 months old

Biological: live attenuated Japanese encephalitis vaccine

EV71 vaccine

ACTIVE COMPARATOR

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

Interventions

EV71 and two measles attenuated live vaccine BIOLOGICAL

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.

EV71 and two measles attenuated live vaccine

EV71 and attenuated Japanese encephalitis vaccine BIOLOGICAL

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.

EV71 and attenuated Japanese encephalitis vaccine

two measles attenuated live vaccine BIOLOGICAL

infants vaccined with one dose two measles attenuated live vaccine at 8 months old.

two measles attenuated live vaccine

live attenuated Japanese encephalitis vaccine BIOLOGICAL

infants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 months old.

live attenuated Japanese encephalitis vaccine

EV71 vaccine BIOLOGICAL

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).

EV71 vaccine

Eligibility Criteria

• Age: 8 Months - 9 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Guangdong Center for Disease Prevention and Control: collaborator

Study Sites (1)

Guangdong Province Center for Diseases Control and Prevention

Guangzhou, Guangdong, 511430, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 28, 2017
• Study Start: September 14, 2017
• Primary Completion: September 2, 2019
• Study Completion: September 2, 2019
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

CN (1)