EUCTR2005-003526-25-DE进行中（未招募）不适用
Safety and immunogenicity of concomitant vaccination with IC51 and Havrix 1440 in healthy subjects. A single-blind randomised, controlled phase 3 study.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Intercell AG
- 入组人数
- 192
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-At least 18 years of age
- •-In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception as specified in protocol section 6.4
- •-Written informed consent obtained prior to study entry (subjects should give their consent themselves. Consent by legal representatives is allowed.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •?History of clinical manifestation of any flavivirus infection
- •?History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer ? 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
- •?History of any previous Hepatitis A vaccination
- •?Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
- •?Planned administration of another vaccine during the study period
- •?Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
- •?A family history of congenital or hereditary immunodeficiency
- •?History of autoimmune disease
- •?Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.05 mg/kg/day. Topical and inhaled steroids are allowed.)
- •?Any acute infections within 4 weeks prior to enrollment
- •?History of severe hypersensitivity reactions in particular to a component of the IC51 vaccine (e.g. protamine sulphate) or HAVRIX® 1440, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission
- •?Infection with HIV (a negative test result within 30 days before enrollment is acceptable), Hepatitis B (HBsAg) or Hepatitis C
- •?History of thrombocytopenia or a bleeding disorder
- •?Drug addiction within 6 months prior to enrollment (including alcohol dependence, i.e. more than approx. 60 g alcohol per day, or conditions which might interfere with the study conduct)
- •?Inability or unwillingness to avoid more than the usual intake of alcohol during the 48 hours after vaccination
- •?Known hypersensitivity to neomycin
- •?Diabetes mellitus in subjects receiving insulin therapy, severe cardiopulmonary disorders, history of malignancy in the past 5 years
- •?Pregnancy (positive pregnancy test during screening or at baseline), lactation or unreliable contraception in female subjects (for details please refer to section 6.4)
- •?Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion
- •?Inability or unwillingness to provide informed consent and to abide by the requirements of the study
研究者
相似试验
进行中（未招募）
1 期
Concomitant administration of the Novavax vaccine and a 20-valent pneumococcal conjugate vaccine in adults aged =60 yearsVaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults (age >60 years). Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the new, Omicron-adapted Novavax (NVX XBB.1.5) vaccine and a 20-valent pneumococcal conjugate vaccine results in lower immunogenicity than the administration of either alone.EUCTR2022-004118-12-ATMedical University of Vienna256
进行中（未招募）
1 期
Immunological responses after concomitant vaccination with the yellow fever-vaccine and the TBE-vaccine, or JE-vaccinePrevention of TBE or Japanece encephalitis by co-vaccination with the yellow fever vaccineEUCTR2017-002137-32-SEHans-Gustaf Ljunggren140
已完成
不适用
Safety and immunogenicity of concomitant administration of a virosomal hepatitis A vaccine (Epaxal®) with DTP, aHib, IPV, OPV and MMR vaccines versus non-concomitant administration in 12 to 15 month-old childreHepatitis AISRCTN82277382Berna Biotech Ltd (Switzerland)322
进行中（未招募）
不适用
An immunogenicity and safety study of combined adsorbed tetanus, low dose diphtheria and acellular pertussis vaccine (Td5ap and Td1aP) given as a school-leaving booster to 14-15-year-old children primed with a five component acellular pertussis vaccine at 3, 5 and 12 months of age, and a booster dose at 5½ years of age. - Tdap Booster studyEUCTR2008-008195-13-SESwedish Institute for Infectious Disease Control (SMI)
已完成
2 期
Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young AdultsInvasive Meningococcal DiseaseNCT01272180Novartis Vaccines484