A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine
This study is currently recruiting participants.
Verified August 2011 by National Health Research Institutes, Taiwan
Sponsor:
National Health Research Institutes, Taiwan
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01268787
First received: December 30, 2010
Last updated: August 8, 2011
Last verified: August 2011
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Purpose
This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers
| Condition | Intervention | Phase |
|---|---|---|
|
Enterovirus Infection |
Biological: EV71 vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase I, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine Administrated With Adjuvant AlPO4 in Health Volunteers |
Further study details as provided by National Health Research Institutes, Taiwan:
Primary Outcome Measures:
- Primary endpoint [ Time Frame: 210 Days ] [ Designated as safety issue: Yes ]The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: EV 71 vaccine 5ug
EV71 Vaccine 5ug
|
Biological: EV71 vaccine
Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.
Other Name: EV71 vac
|
|
Experimental: EV 71 vaccine 10ug
EV71 vaccine 10ug
|
Biological: EV71 vaccine
Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.
Other Name: EV71 vac
|
Detailed Description:
This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy volunteers will be screened for baseline characteristic inclusion/exclusion criteria after providing a written informed consent. Eligible subjects will be recruited and equally randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be followed till Day 210.
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subject who is free of obvious health problems
- Able and willing to comply with the study procedure adn give written informed consent
Exclusion Criteria:
- Female who is pregnant/lactating or planning to be pregnant
- Body mass index(BMI) > 35
- Oral temperature > 37.5 Celsius at the time of planned vaccination
- Subject with any abnormal laboratory results at screening
- With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months
- Has been diagnosed with neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder
- With a history of hypersensitivity to vaccine or allergic disease
- Use of any investigational/non-registered product within 30 days prior to vaccination
- Use of immunoglobulins or any blood products within 3 months prior to vaccination
- Chronic administration of immunosuppressants or other immunomodulators within 5 months prior to vaccination
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268787
Contacts
| Contact: Mei Hu, B.S | +886-37-246166 ext 37958 | meihua@nhri.org.tw |
Locations
| Taiwan | |
| Taipei Veterans General Hospital | Recruiting |
| Taipei, Shihlin District, Taiwan, 112 | |
| Contact: C P Fung, MD +886-2-28712121 cpfung@vghtpe.gov.tw | |
| Principal Investigator: C P Fung, M.D | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Zhongshan Distric, Taiwan, 104 | |
| Contact: S M Hsieh, M.D. 886-2-23123456 hsmaids@hotmail.com | |
| Principal Investigator: S M Hsieh, M.D. | |
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Investigators
| Study Chair: | Pele Chone, Ph.D. | National Health Research Institutes, Taiwan |
| Study Director: | Chia Liu, Ph.D. | National Health Research Institutes, Taiwan |
| Principal Investigator: | C P Fung, M.D. | Taipei Veterans General Hospital,Taiwan |
| Principal Investigator: | S M Hsieh, M.D | Taipei Meidcal College |
More Information
No publications provided
| Responsible Party: | Vaccine Research and Developmental Center, Tawian, National Health Research Institutes, Tawian |
| ClinicalTrials.gov Identifier: | NCT01268787 History of Changes |
| Other Study ID Numbers: | QCR-10013 |
| Study First Received: | December 30, 2010 |
| Last Updated: | August 8, 2011 |
| Health Authority: | Taiwan : Food and Drug Administration Taiwan: Center for Drug Evaluation Taiwan: Department of Health Taiwan: Institutional Review Board |
Additional relevant MeSH terms:
|
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on June 18, 2013