Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, and Children in India and Healthy Adolescents and Children in the Republic of South Africa - MET55

Sanofi Pasteur Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年6月26日

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•1 Z-score of >= -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards
•1.1 For children : Children aged 2 to 5 years must have a Z-score of >= -2 SD on the Weight-for-height table of the WHO Child Growth Standards
•2. Informed consent obtained
•2.1 For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations
•2.1.1 For children and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations
•3. Able to attend all scheduled visits and to comply with all trial procedures
•3.1 For adults: Able to attend all scheduled visits and to comply with all trial procedures
•3.2 For children and adolescents: Participants and parent / legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.

•1. Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile
•2. Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•3. Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following vaccination except for oral poliovirus vaccine (OPV) in India, received during national immunization days. In India, OPV may be received with a gap of at least 2 weeks before the study vaccine. This exception includes monovalent and bivalent OPV.
•4. 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)

发起方

Sanofi Pasteur Inc