A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered with or without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 1,800 人开始时间: 2008年6月12日最近更新: 2012年3月19日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 1,800

研究概览入排标准研究者记录与标识符相似试验

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

•1. Healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg.
•2. For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained.
•3. Available for all the visits scheduled in the study.
•4. In good health as determined by medical history, physical examination and clinical judgment of the investigator.
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•1. History of any meningococcal B or C vaccine administration.
•2. Prior vaccination with any Diphtheria, Tetanus, Pertussis (acellular or whole cell), Polio (either Inactivated or Oral), Haemophilus influenzae type b (Hib), and Pneumococcal antigens.
•3. Previous ascertained or suspected disease caused by N. meningitidis.
•4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
•5. History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component.
•6. Significant acute or chronic infection within the previous 7 days or axillary temperature = 38°C within the previous day.
•7. Antibiotics within 6 days prior to enrollment.
•8. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin dependent diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
•9. Known or suspected impairment/alteration of the immune system, such as immunosuppressive therapy, including use of corticosteroids or chronic use of inhaled high-potency corticosteroids since birth.
•10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
•11. Receipt of, or intent to immunize with any other vaccine(s) (with the exception of rotavirus), within 30 days prior and throughout the study period.
•12. Participation in another clinical trial since birth or planned for during study.
•13. Family members and household members of research staff;
•14. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

研究者

发起方

ovartis Vaccines and Diagnostics S.r.l.

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A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered with or without Routine Infant Vaccinations to Healthy Infants According to Different Immunization SchedulesThe Novartis Meningococcal B Recombinant + OMV NZ Vaccine is intended for prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B. The objective of the Novartis Meningococcal B Recombinant + OMV vaccine is to identify a vaccine candidate that is safe and provide functional immune responses against heterologous meningococcal B strains.MedDRA version: 9.1Level: LLTClassification code 10027276Term: Meningococcal meningitis

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EUCTR2019-004475-39-ITJanssen Sciences Ireland Unlimited Company24