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

Enimmune Corporation4 sites in 1 country122 target enrollmentDecember 2014

ConditionsEnterovirus Infections

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Enterovirus Infections
Sponsor: Enimmune Corporation
Enrollment: 122
Locations: 4
Primary Endpoint: Unsolicited adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

January 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Enimmune Corporation

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

Unsolicited adverse events

Time Frame: 28 days after each vaccination

Solicited adverse events

Time Frame: 7 days after each vaccination

The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)

Time Frame: Day 0 to Day 196

Secondary Outcomes

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)
change in the laboratory results based on hematology tests in each visit(Day 28, Day 56, Day 196)
change in blood pressures at each visit (for the 3 to 6 years old group only)(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 biochemistry tests in each visit(Day 28, Day 56, Day 196)
change in heart rates at each visit (for the 3 to 6 years old group only)(Day 28, Day 56, Day 196)