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
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
1 other identifier
interventional
122
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2014
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 16, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedNovember 30, 2016
August 1, 2016
1.1 years
May 16, 2016
November 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Solicited adverse events
7 days after each vaccination
Unsolicited adverse events
28 days after each vaccination
The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)
Day 0 to Day 196
Secondary Outcomes (7)
immunoglobulin G (IgG) titers induced by the EV71 vaccine ( determined by ELISA)
Day 28, Day 56, Day 196
serum neutralizing antibody titers (NT) induced by the EV71 vaccine
Day 28, Day 56, Day 196
Seroconversion rate (SCR) based on neutralizing antibody titers
Day 28, Day 56, Day 196
change in the laboratory results based on hematology tests in each visit
Day 28, Day 56, Day 196
change in the laboratory results based on biochemistry tests in each visit
Day 28, Day 56, Day 196
- +2 more secondary outcomes
Study Arms (7)
Group A1
EXPERIMENTAL3 to 6 years
Group A2
EXPERIMENTAL3 to 6 years
Group A3
EXPERIMENTAL3 to 6 years
Group A4
EXPERIMENTAL3 to 6 years
Group B2
EXPERIMENTAL6 to 35 months
Group B3
EXPERIMENTAL6 to 35 months
Group B4
EXPERIMENTAL6 to 35 months
Interventions
Two vaccinations at 28 days apart
Two vaccinations at 28 days apart
Two vaccinations at 28 days apart
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
China Medical University Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2016
First Posted
May 19, 2016
Study Start
December 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
November 30, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share