Immunogenicity and safety study of an investigational quadrivalent meningococcal conjugate vaccine in infants and toddlers when administered using a 1+1 schedule in a National Immunization Schedule having a meningococcal Group B Vaccine as standard of care

Sanofi Pasteur0 个研究点目标入组 700 人开始时间: 2018年3月20日最近更新: 2020年11月9日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Sanofi Pasteur
入组人数: 700

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

•An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
•1) Aged = 56 to = 89 days on the day of the first study visit
•2) Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg (or 5 lb and 8 oz)
•3) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
•4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 700
•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

•An individual fulfilling any of the following criteria is to be excluded from study enrollment:
•1) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•2) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
•3) Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
•4) Previous vaccination with any pneumococcal, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), poliovirus, and/or rotavirus vaccines. Receipt of BCG vaccine at birth is acceptable
•5) Receipt of immune globulins, blood or blood-derived since birth
•6) Known or suspected congenital or acquired immunodeficiency, including Severe Combined Immunodeficiency disorder (SCID); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
•7) History of any neurologic disorders, including any seizures and progressive neurologic disorders or encephalopathy
•8) History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
•9) History of diphtheria, tetanus, pertussis, poliomyelitis, Hib, hepatitis B, Streptococcus pneumoniae, and/or rotavirus infection or disease
•10) At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
•11) History of Guillain-Barré syndrome
•12) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances including neomycin, kanamycin, polymyxin, formaldehyde, and latex
•13) Hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
•14) History of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose to intussusception
•15) Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the investigator’s opinion
•16) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
•17) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
•18) Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, including planning to leave the area of the study site before the end of the study
•19) Moderate or severe acute illness/infection (according

研究者

发起方

Sanofi Pasteur

相似试验

进行中（未招募）

1 期

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine when co-administered with Routine Pediatric Vaccines in Healthy Infants and Toddlers in EuropeHealthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)MedDRA version: 20.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestations

EUCTR2017-004731-36-ITSanofi Pasteur Inc.1,540

进行中（未招募）

1 期

EUCTR2017-004731-36-FISanofi Pasteur Inc.1,652

进行中（未招募）

1 期

EUCTR2017-004731-36-SESanofi Pasteur Inc.1,652

进行中（未招募）

1 期

EUCTR2017-004731-36-ESSanofi Pasteur Inc.1,540

进行中（未招募）

1 期

EUCTR2017-004731-36-CZSanofi Pasteur Inc.1,652