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CompletedNCT02777411Updated Nov 30, 2016

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

A Phase 2 interventional study of EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose) and EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose) in Enterovirus Infections, sponsored by Enimmune Corporation. Completed at 4 sites in Taiwan. Open to participants aged 6 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-30.

Sponsored by Enimmune Corporation · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
6 Months to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Enterovirus Infections

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Keywords

  • Vaccines
  • Hand, Foot and Mouth Disease
  • EV71 enteroviruses vaccine
03

In context

Enterovirus Infections

47 studies on the registry are indexed under Enterovirus Infections; 5 are open to participants now.

This study's enrollment of 122 is below the median of 150 across 31 interventional studies indexed under Enterovirus Infections.

Browse Enterovirus Infections studies →

Lead sponsor

Enimmune Corporation is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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.
  2. Subject's guardians were able and willing to comply with study procedures and give written informed consent.
  3. Subject was able and could comply with the requirements of the protocol.
  4. Subject with body temperature ≤38°C.

Exclusion criteria

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 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 7 days prior to vaccination.
  15. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
  16. Chronic administration (defined as > 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination.
  17. Under anti-tuberculosis prevention or therapy.
  18. Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    Group A1

    3 to 6 years

    Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)

  • Experimental
    Group A2

    3 to 6 years

    Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)

  • Experimental
    Group A3

    3 to 6 years

    Biological: EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)

  • Experimental
    Group A4

    3 to 6 years

    Biological: EV71 vaccine (2 μg total protein per dose)

  • Experimental
    Group B2

    6 to 35 months

    Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)

  • Experimental
    Group B3

    6 to 35 months

    Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)

  • Experimental
    Group B4

    6 to 35 months

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

Interventions

  • BiologicalEV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)

    Two vaccinations at 28 days apart

  • BiologicalEV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)

    Two vaccinations at 28 days apart

  • BiologicalEV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)

    Two vaccinations at 28 days apart

  • BiologicalEV71 vaccine (2 μg total protein per dose)

    Two vaccinations at 28 days apart

  • BiologicalEV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)

    Two vaccinations at 28 days apart

  • BiologicalEV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)

    Two vaccinations at 28 days apart

  • BiologicalEV71 vaccine (1 μg total protein per dose)

    Two vaccinations at 28 days apart

06

What researchers measure

Primary outcomes

  1. Solicited adverse events

    Time frame: 7 days after each vaccination

  2. Unsolicited adverse events

    Time frame: 28 days after each vaccination

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

    Time frame: Day 0 to Day 196

Secondary outcomes

  1. immunoglobulin G (IgG) titers induced by the EV71 vaccine ( determined by ELISA)

    Time frame: Day 28, Day 56, Day 196

  2. serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    Time frame: Day 28, Day 56, Day 196

  3. Seroconversion rate (SCR) based on neutralizing antibody titers

    Time frame: Day 28, Day 56, Day 196

  4. change in the laboratory results based on hematology tests in each visit

    Time frame: Day 28, Day 56, Day 196

  5. change in the laboratory results based on biochemistry tests in each visit

    Time frame: Day 28, Day 56, Day 196

  6. change in heart rates at each visit (for the 3 to 6 years old group only)

    Time frame: Day 28, Day 56, Day 196

  7. change in blood pressures at each visit (for the 3 to 6 years old group only)

    Time frame: Day 28, Day 56, Day 196

07

Study locations

4 sites
  • China Medical University Hospital
    Taichung, Taiwan
  • National Taiwan University Hospital
    Taipei, Taiwan
  • Taipei Veterans General Hospital
    Taipei, Taiwan
  • Linkou Chang Gung Memorial Hospital
    Tao Yuan, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02777411
Lead sponsor
Enimmune Corporation
Responsible party
Sponsor
First posted
May 19, 2016
Start date
Dec 2014
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Nov 30, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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