Back to resultsA Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
Primary Purpose
Enterovirus Infections
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)
EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)
EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)
EV71 vaccine (2 μg total protein per dose)
EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)
EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)
EV71 vaccine (1 μg total protein per dose)
Sponsored by
About this trial
This is an interventional prevention trial for Enterovirus Infections focused on measuring Vaccines, Hand, Foot and Mouth Disease, EV71 enteroviruses vaccine
Eligibility Criteria
Inclusion Criteria:
- Healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and < 7 years old) for Part A; from 6 to 35 months old (i.e. ≥ 6 months old and < 36 months old) for Part B at the time of first vaccination.
- Subject's guardians were able and willing to comply with study procedures and give written informed consent.
- Subject was able and could comply with the requirements of the protocol.
- Subject with body temperature ≤38°C.
Exclusion Criteria:
- Subject with previous known exposure to Enterovirus 71 (EV71).
- Subject with a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
- Subject with gestation < 37 weeks.
- Subject with birth weight <2.5 kg.
- 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.
- Family history of seizures or progressive neurological disease.
- Family history of congenital or hereditary immunodeficiency.
- Severe malnutrition or dysgenopathy.
- Major congenital defects or serious chronic illness, including perinatal brain damage.
- 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).
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws.
- Any acute infections 7 days prior to administrate the first vaccination.
- Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period.
- Administration of any attenuated live vaccine within 7 days prior to vaccination.
- Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
- Chronic administration (defined as > 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination.
- Under anti-tuberculosis prevention or therapy.
- Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
Sites / Locations
- China Medical University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Linkou Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A1
Group A2
Group A3
Group A4
Group B2
Group B3
Group B4
Arm Description
3 to 6 years
3 to 6 years
3 to 6 years
3 to 6 years
6 to 35 months
6 to 35 months
6 to 35 months
Outcomes
Primary Outcome Measures
Solicited adverse events
Unsolicited adverse events
The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)
Secondary Outcome Measures
immunoglobulin G (IgG) titers induced by the EV71 vaccine ( determined by ELISA)
serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Seroconversion rate (SCR) based on neutralizing antibody titers
change in the laboratory results based on hematology tests in each visit
change in the laboratory results based on biochemistry tests in each visit
change in heart rates at each visit (for the 3 to 6 years old group only)
change in blood pressures at each visit (for the 3 to 6 years old group only)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02777411
Brief Title
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
Official Title
An Open-label, Dose-finding, Phase II Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enimmune Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objectives of this study are to evaluate the immune response and safety profiles of two 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 (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterovirus Infections
Keywords
Vaccines, Hand, Foot and Mouth Disease, EV71 enteroviruses vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A1
Arm Type
Experimental
Arm Description
3 to 6 years
Arm Title
Group A2
Arm Type
Experimental
Arm Description
3 to 6 years
Arm Title
Group A3
Arm Type
Experimental
Arm Description
3 to 6 years
Arm Title
Group A4
Arm Type
Experimental
Arm Description
3 to 6 years
Arm Title
Group B2
Arm Type
Experimental
Arm Description
6 to 35 months
Arm Title
Group B3
Arm Type
Experimental
Arm Description
6 to 35 months
Arm Title
Group B4
Arm Type
Experimental
Arm Description
6 to 35 months
Intervention Type
Biological
Intervention Name(s)
EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)
Intervention Description
Two vaccinations at 28 days apart
Intervention Type
Biological
Intervention Name(s)
EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)
Intervention Description
Two vaccinations at 28 days apart
Intervention Type
Biological
Intervention Name(s)
EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)
Intervention Description
Two vaccinations at 28 days apart
Intervention Type
Biological
Intervention Name(s)
EV71 vaccine (2 μg total protein per dose)
Intervention Description
Two vaccinations at 28 days apart
Intervention Type
Biological
Intervention Name(s)
EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)
Intervention Description
Two vaccinations at 28 days apart
Intervention Type
Biological
Intervention Name(s)
EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)
Intervention Description
Two vaccinations at 28 days apart
Intervention Type
Biological
Intervention Name(s)
EV71 vaccine (1 μg total protein per dose)
Intervention Description
Two vaccinations at 28 days apart
Primary Outcome Measure Information:
Title
Solicited adverse events
Time Frame
7 days after each vaccination
Title
Unsolicited adverse events
Time Frame
28 days after each vaccination
Title
The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)
Time Frame
Day 0 to Day 196
Secondary Outcome Measure Information:
Title
immunoglobulin G (IgG) titers induced by the EV71 vaccine ( determined by ELISA)
Time Frame
Day 28, Day 56, Day 196
Title
serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Time Frame
Day 28, Day 56, Day 196
Title
Seroconversion rate (SCR) based on neutralizing antibody titers
Time Frame
Day 28, Day 56, Day 196
Title
change in the laboratory results based on hematology tests in each visit
Time Frame
Day 28, Day 56, Day 196
Title
change in the laboratory results based on biochemistry tests in each visit
Time Frame
Day 28, Day 56, Day 196
Title
change in heart rates at each visit (for the 3 to 6 years old group only)
Time Frame
Day 28, Day 56, Day 196
Title
change in blood pressures at each visit (for the 3 to 6 years old group only)
Time Frame
Day 28, Day 56, Day 196
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and < 7 years old) for Part A; from 6 to 35 months old (i.e. ≥ 6 months old and < 36 months old) for Part B at the time of first vaccination.
Subject's guardians were able and willing to comply with study procedures and give written informed consent.
Subject was able and could comply with the requirements of the protocol.
Subject with body temperature ≤38°C.
Exclusion Criteria:
Subject with previous known exposure to Enterovirus 71 (EV71).
Subject with a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
Subject with gestation < 37 weeks.
Subject with birth weight <2.5 kg.
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.
Family history of seizures or progressive neurological disease.
Family history of congenital or hereditary immunodeficiency.
Severe malnutrition or dysgenopathy.
Major congenital defects or serious chronic illness, including perinatal brain damage.
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).
Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws.
Any acute infections 7 days prior to administrate the first vaccination.
Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period.
Administration of any attenuated live vaccine within 7 days prior to vaccination.
Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
Chronic administration (defined as > 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination.
Under anti-tuberculosis prevention or therapy.
Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Tao Yuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
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