Clinical Trials List
Protocol NumberEV-RB1401
2014-03-01 - 2016-03-31
Phase II
Terminated3
Study ended1
ICD-10Z23
Encounter for immunization
ICD-9V05.8
Need for other prophylactic vaccination and inoculation against other specified disease
An Open-Label, Dose-Finding, Phase II Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Paediatric Subjects aged 3 to 6 years and 2 to 35 months old
-
Trial Applicant
QPS
-
Sponsor
Adimmune Corporation
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chun-yi Lu Division of Pediatrics
- 馬瑄吟 Division of Pediatrics
- Luan-Yin Chang Division of Pediatrics
- 吳仲琳 Division of Pediatrics
- 賴貞吟 Division of Pediatrics
- 黃文嬋 Division of Pediatrics
- 林谷龍 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳俊仁 Division of Pediatrics
- Chou-Cheng Lai Division of Pediatrics
- 張羅以 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Cheng-Hsun Chiu Division of Pediatrics
- 郭貞孍 Division of Pediatrics
- 謝育嘉 Division of Pediatrics
- Chi-Long Chen Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- An-Chyi Chen Division of Pediatrics
- Hung-Chih Lin Division of Pediatrics
- Hsiao-chuan Lin Division of Pediatrics
The Actual Total Number of Participants Enrolled
32 Study ended
Condition/Disease
Prevention of Enterovirus 71 infection
Objectives
Enteroviruses (EV) are small, positive-strand RNA (ribonucleic acid) viruses associatedwith several human and mammalian diseases. It can cause outbreaks ofhand-foot-and-mouth disease (HFMD) or herpangina, and is sometimes associated withsevere neurologic complications. Several enterovirus epidemics have been reported inTaiwan, and enterovirus 71 (EV-71) infections were associated with most of the seriousclinical manifestations, including encephalitis, aseptic meningitis, pulmonary edema,myocarditis and so on.The objectives of this study are to evaluate the immune response and safety profiles oftwo injections of EV71 Vaccine administrated with or without adjuvant AlPO4 at 0.5-μg,1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (ifrequired), 0.5-μg, 1-μg and 2-μg (if required) in 2 to 35 months old infants/toddlers.
Test Drug
EV71 vaccine
Active Ingredient
cell-based, formalininactivated, monovalent EV71 whole virion (subtype B4)
Dosage Form
vial
Dosage
0.25、0.5、1、2、5 ; 2 ; 1
Endpoints
Primary endpoint:
♦ The percentage, intensity and relationship to vaccination of local and systemic
signs and symptoms range of (0.25-μg) 0.5-μg, 1-μg and 2-μg (5-μg) dose after
the first and second vaccination, respectively:
o Solicited adverse events: during 7-days follow-up period
o Unsolicited adverse events: during 28-days follow-up period
o The occurrence of overall AEs and SAEs through study period.
Secondary endpoints:
(1) Evaluate the immunogenicity change of IgG titers induced by the EV71 vaccine
(by ELISA) from baseline at range of (0.25-μg) 0.5-μg, 1-μg and 2-μg (5-μg)
dose on Day 28, Day 56 and Day 196.
(2) Evaluate the immunogenicity change of serum neutralizing antibody titers
induced by the EV71 vaccine from baseline at range of (0.25-μg) 0.5-μg, 1-μg
and 2-μg (5-μg) dose on Day 28, Day 56 and Day 196.
(3) Evaluate the immunogenicity change of seroconversion rate* (SCR) from
baseline at range of (0.25-μg) 0.5-μg, 1-μg and 2-μg (5-μg) dose on Day 28,
Day 56 and Day 196
* SCR define as the percentage of subjects achieving either a pre-vaccination
neutralizing antibody titer <1:8 and a post-vaccination neutralizing antibody titer ≥1:32
OR a pre-vaccination neutralizing antibody titer ≥1:8 and a minimum 4-fold increase in
post-vaccination neutralizing antibody titer
(4) The change in the laboratory results in each visit:
o Hematology
o Biochemistry
(5) The change in vital signs in each visit:
o Heart rate (HR)
o Blood pressure (BP)
♦ The percentage, intensity and relationship to vaccination of local and systemic
signs and symptoms range of (0.25-μg) 0.5-μg, 1-μg and 2-μg (5-μg) dose after
the first and second vaccination, respectively:
o Solicited adverse events: during 7-days follow-up period
o Unsolicited adverse events: during 28-days follow-up period
o The occurrence of overall AEs and SAEs through study period.
Secondary endpoints:
(1) Evaluate the immunogenicity change of IgG titers induced by the EV71 vaccine
(by ELISA) from baseline at range of (0.25-μg) 0.5-μg, 1-μg and 2-μg (5-μg)
dose on Day 28, Day 56 and Day 196.
(2) Evaluate the immunogenicity change of serum neutralizing antibody titers
induced by the EV71 vaccine from baseline at range of (0.25-μg) 0.5-μg, 1-μg
and 2-μg (5-μg) dose on Day 28, Day 56 and Day 196.
(3) Evaluate the immunogenicity change of seroconversion rate* (SCR) from
baseline at range of (0.25-μg) 0.5-μg, 1-μg and 2-μg (5-μg) dose on Day 28,
Day 56 and Day 196
* SCR define as the percentage of subjects achieving either a pre-vaccination
neutralizing antibody titer <1:8 and a post-vaccination neutralizing antibody titer ≥1:32
OR a pre-vaccination neutralizing antibody titer ≥1:8 and a minimum 4-fold increase in
post-vaccination neutralizing antibody titer
(4) The change in the laboratory results in each visit:
o Hematology
o Biochemistry
(5) The change in vital signs in each visit:
o Heart rate (HR)
o Blood pressure (BP)
Inclution Criteria
(1) Healthy children aged from 3 to 6 years old for Part A; from 2 to 35 months old
for Part B at the time of first vaccination.
(2) Subject’s guardians are able and willing to comply with study procedures and give written informed consent.
(3) Subject is able and can comply with the requirements of the protocol.
(4) Subject with ear temperature ≤37.5℃
for Part B at the time of first vaccination.
(2) Subject’s guardians are able and willing to comply with study procedures and give written informed consent.
(3) Subject is able and can comply with the requirements of the protocol.
(4) Subject with ear temperature ≤37.5℃
Exclusion Criteria
(1) Subject with previous known exposure to Enterovirus 71 (EV71).
(2) Subject with a history of herpangina, hand-foot-mouth disease, acute
hemorrhagic conjunctivitis or acute gastrointestinal illness associated with
enterovirus infection in the past 3 months.
(3) Subject with gestation ≤37 weeks.
(4) Subject with birth weight <2.5 kg.
(5) Subject with a history of hypersensitivity to vaccines, or a history of allergic
disease or reactions likely to be exacerbated by any component of the vaccine.
(6) Family history of seizures or progressive neurological disease.
(7) Family history of congenital or hereditary immunodeficiency.
(8) Severe malnutrition or dysgenopathy.
(9) Major congenital defects or serious chronic illness, including perinatal brain
damage.
(10) Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I
diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile
idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura).
(11) Bleeding disorder diagnosed by a doctor or significant bruising or bleeding
difficulties with IM injections or blood draws.
(12) Any acute infections 7 days prior to administrate the first vaccination.
(13) Use of any investigational product (including drug, vaccine) within 30 days prior
to vaccination or planned use during the study period.
(14) Administration of any attenuated live vaccine within 28 days prior to vaccination.
(15) Administration of any inactivated vaccines (eg., pneumococcal vaccine)
within14 days prior to vaccination.
(16) Use of immunoglobulins or any blood products within 3 months prior to
vaccination or planned use during the study period.
(17) Chronic administration (defined as > 14 days) of immunosuppressants or other
immunomodulators or systemic corticosteroids within 6 months prior to
vaccination.
(18) Under anti-tuberculosis prevention or therapy
(19) Any condition that in the opinion of the investigator may interfere with the
evaluation of study objectives.
(2) Subject with a history of herpangina, hand-foot-mouth disease, acute
hemorrhagic conjunctivitis or acute gastrointestinal illness associated with
enterovirus infection in the past 3 months.
(3) Subject with gestation ≤37 weeks.
(4) Subject with birth weight <2.5 kg.
(5) Subject with a history of hypersensitivity to vaccines, or a history of allergic
disease or reactions likely to be exacerbated by any component of the vaccine.
(6) Family history of seizures or progressive neurological disease.
(7) Family history of congenital or hereditary immunodeficiency.
(8) Severe malnutrition or dysgenopathy.
(9) Major congenital defects or serious chronic illness, including perinatal brain
damage.
(10) Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I
diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile
idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura).
(11) Bleeding disorder diagnosed by a doctor or significant bruising or bleeding
difficulties with IM injections or blood draws.
(12) Any acute infections 7 days prior to administrate the first vaccination.
(13) Use of any investigational product (including drug, vaccine) within 30 days prior
to vaccination or planned use during the study period.
(14) Administration of any attenuated live vaccine within 28 days prior to vaccination.
(15) Administration of any inactivated vaccines (eg., pneumococcal vaccine)
within14 days prior to vaccination.
(16) Use of immunoglobulins or any blood products within 3 months prior to
vaccination or planned use during the study period.
(17) Chronic administration (defined as > 14 days) of immunosuppressants or other
immunomodulators or systemic corticosteroids within 6 months prior to
vaccination.
(18) Under anti-tuberculosis prevention or therapy
(19) Any condition that in the opinion of the investigator may interfere with the
evaluation of study objectives.
The Estimated Number of Participants
-
Taiwan
180 participants
-
Global
180 participants
