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Trial record 30 of 32 for:    "Hand, Foot and Mouth Disease"

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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ClinicalTrials.gov Identifier: NCT02777411
Recruitment Status : Completed
First Posted : May 19, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Enimmune Corporation

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.

Condition or disease Intervention/treatment Phase
Enterovirus Infections Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose) Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose) Biological: EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose) Biological: EV71 vaccine (2 μg total protein per dose) Biological: EV71 vaccine (1 μg total protein per dose) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : December 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Experimental: Group A1
3 to 6 years
Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)
Two vaccinations at 28 days apart

Experimental: Group A2
3 to 6 years
Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)
Two vaccinations at 28 days apart

Experimental: Group A3
3 to 6 years
Biological: EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)
Two vaccinations at 28 days apart

Experimental: Group A4
3 to 6 years
Biological: EV71 vaccine (2 μg total protein per dose)
Two vaccinations at 28 days apart

Experimental: Group B2
6 to 35 months
Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)
Two vaccinations at 28 days apart

Experimental: Group B3
6 to 35 months
Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)
Two vaccinations at 28 days apart

Experimental: Group B4
6 to 35 months
Biological: EV71 vaccine (1 μg total protein per dose)
Two vaccinations at 28 days apart




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777411


Locations
Taiwan
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
Sponsors and Collaborators
Enimmune Corporation

Responsible Party: Enimmune Corporation
ClinicalTrials.gov Identifier: NCT02777411     History of Changes
Other Study ID Numbers: EV-RB1401
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Enimmune Corporation:
Vaccines
Hand, Foot and Mouth Disease
EV71 enteroviruses vaccine

Additional relevant MeSH terms:
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs