KCT0000604
Recruiting
未知
Assessment of the safety, tolerance, and immunogenicity of EG-HPV (human papillomavirus vaccine) in healthy male adult volunteers:A double-blinded, randomized, adjuvant vehicle-controlled trial
Eyegene0 sites24 target enrollmentTBD
ConditionsNot Applicable
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- Eyegene
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy male adults aged 20 years or older
- •2\. Weighed 45 kg or over, and in the range of ideal body weight\* ± 20 %
- •\*Ideal Body Weight \= \[height (in cm)\-100]?0\.9
- •3\. No deviation from normal range in vital signs, physical examination, haematology, blood coagulation test, biochemistry, urinalysis, or 12\-lead ECG performed within 4 weeks prior to the study as determined by the investigator
- •4\. Willingness to participate in the study
- •5\. Written informed consent
Exclusion Criteria
- •1\.Prior receipt of a HPV vaccine
- •2\.Any history of anaphylaxis in reaction to vaccination
- •3\.Seropositive for HPV 16 or HPV 18 (\> 7 unit)
- •4\.History of fever or infectious disease within 2 weeks prior to the study
- •5\.History of a whole blood donation within 2 months or a component donation within one month prior to the study, or planned donation during the study period
- •6\.Any vaccination within 2 months prior to the study
- •7\.Any immunological disorder or administration of immunological therapy including cyclophosphamide, azathiprine, leflunomide, TNF\-a antagonist, therapeutic monoclonal antibody, intravenous gamma immunoglobulin, high dose of systemic corticosteroid hormone therapy
- •8\.Thrombocytopenia or any other coagulation disorder
- •9\.History of fever (oral temperature \=100? or \=37\.8?) within 24 hours prior to the vaccination
- •10\.Chronic drug abuse or alcohol abuse (an alcohol intake of greater than 28 units every week)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
Subcutaneous immunotherapy with PROLINEM -Asthma- Adults-Fase IAsthmaRPCEC00000139ational Center of Bioproducts (BioCen)20
Active, not recruiting
Phase 1
India Registration Study for Quadrivalent HPV VaccineEUCTR2017-000111-16-Outside-EU/EEAMerck & Co., Inc.110
Active, not recruiting
Phase 1
A study to Evaluate Immunogenicity, Safety and Tolerability of a Single Dose of ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2COVID-19 diseaseMedDRA version: 23.1Level: PTClassification code 10084457Term: COVID-19 immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2021-005504-36-DKBavarian Nordic A/S4,000
Completed
Not Applicable
Assessment of the immunogenicity and safety of the Northern Hemisphere 2010/2011-season influenza vaccine in elderly and young subjects according to European Medicines Agency (EMEA) regulationsISRCTN89337058Crucell Switzerland AG (Switzerland)110
Completed
Not Applicable
Assessment of the immunogenicity and safety of the Northern Hemisphere 2009/2010-season influenza vaccine in elderly and young subjects according to European Medicines Agency (EMEA) regulationsISRCTN30202688Crucell, Berna Biotech Ltd (Switzerland)110