NCT03268083

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 Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

August 4, 2016

Last Update Submit

October 18, 2021

Conditions

Enterovirus Infections

Keywords

Foot-and-Mouth DiseaseVaccinesHand, Foot and Mouth DiseaseEV71 vaccine

Outcome Measures

Primary Outcomes (6)

  • Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 56

    Day 56

  • Seroconversion rate (SCR) based on neutralizing antibody titers

    Evaluate the immunogenicity change of SCR from baseline on Day 56

    Day 56

  • Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 28

    Day 28

  • Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 196

    Day 196

  • Seroconversion rate (SCR) based on neutralizing antibody titers

    Evaluate the immunogenicity change of SCR from baseline on Day 28

    Day 28

  • Seroconversion rate (SCR) based on neutralizing antibody titers

    Evaluate the immunogenicity change of SCR from baseline on Day 196

    Day 196

Secondary Outcomes (5)

  • 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

  • The occurrence of EV 71 breakthrough infection after Visit 3

    Day 57 to Day 364

  • Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    Day 364

Study Arms (6)

Group A1

EXPERIMENTAL

3 to 6 years

Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)

Group A2

EXPERIMENTAL

3 to 6 years

Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)

Group A3

EXPERIMENTAL

3 to 6 years

Biological: EV71 vaccine ([1 μg total protein ] per dose)

Group B1

EXPERIMENTAL

2 to 35 months

Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)

Group B2

EXPERIMENTAL

2 to 35 months

Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)

Group B3

EXPERIMENTAL

2 to 35 months

Biological: EV71 vaccine ([1 μg total protein ] per dose)

Interventions

EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)BIOLOGICAL

Two vaccinations at 28 days apart

Group A1Group B1
EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)BIOLOGICAL

Two vaccinations at 28 days apart

Group A2Group B2
EV71 vaccine ([1 μg total protein ] per dose)BIOLOGICAL

Two vaccinations at 28 days apart

Group A3Group B3

Eligibility Criteria

Age2 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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,and from 2 to 35 months old (i.e. ≥ 2 months old and \< 36 months old) for Part B at the time of first vaccination.
  • Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
  • Subject is able and can 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,and 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 hemostatic difficulties with IM injections or blood draws.
  • Any acute infections 7 days prior to administrating 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 vaccines within 14 days prior to randomization.
  • Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

China Medical University Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (1)

  • Hung MC, Cho CY, Chen CJ, Lai CC, Wu KG. Immunogenicity and safety of an inactivated enterovirus A71 vaccine in children 3-6 years and 2-35 months of age- an open-label, randomized phase IIb clinical trial. Vaccine. 2019 Sep 3;37(37):5559-5566. doi: 10.1016/j.vaccine.2019.07.096. Epub 2019 Aug 6.

    PMID: 31399275DERIVED

MeSH Terms

Conditions

Enterovirus InfectionsFoot-and-Mouth DiseaseHand, Foot and Mouth Disease

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Picornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsAnimal DiseasesCoxsackievirus Infections

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

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

August 4, 2016

First Posted

August 31, 2017

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

December 1, 2017

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(4)