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The primary objective of this study is to demonstrate the non-inferiority of immunogenicity of a single dose of MenACYW conjugate vaccine compared to Menactra® in adolescents and children aged 2 to 17 years in terms of serum bactericidal assay using human complement (hSBA) titers.
The secondary objectives of the study are:
- To describe the antibody titers to the meningococcal serogroups A, C, Y, and W before and at Day 30 after vaccination with MenACYW conjugate vaccine or a licensed meningococcal vaccine in adults in India aged 18 to 55 years (Menactra®) or ≥ 56 years (Quadri Meningo™)
- To describe the antibody titers to the meningococcal serogroups A, C, Y, and W before and at Day 30 after vaccination with MenACYW conjugate vaccine or Menactra® in children and adolescents aged 2 to 17 years in India and/or Republic of South Africa (RSA)
Study duration per participant is approximately 31 to 45 days
Healthy Volunteers (Meningococcal Infection)
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine, Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine
Not yet recruiting
Published on BioPortfolio: 2019-11-03T15:10:59-0500
The primary objective of the study is to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y when MenACYW conjugate vaccine is administered...
The purpose of the study is to demonstrate the immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of ...
Invasive meningococcal disease and meningococcal meningitis caused by Neisseria meningitidis have their highest incidence in children, with a second peak in adolescents and young adults. T...
The purpose of the study is to evaluate the quadrivalent meningococcal conjugate vaccine when used as a single-dose toddler vaccine in individuals who are either meningococcal vaccine naï...
This study was designed to generate data for the assessment of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years. Prim...
We assessed immunogenicity, antibody persistence and safety of the meningococcal serogroups A, C, W and Y-tetanus toxoid (TT) conjugate vaccine (MenACWY-TT) in children primed as toddlers with MenC va...
Meningococcal conjugate vaccine was administered for the first time to pilgrims in 2018 in Turkey prior to their departure to the Hajj. This study aimed to determine the effect of vaccination on the p...
Meningococcal B (MenB) vaccine is the new kid on the block for children and adolescents, having won Food and Drug Administration approval in 2014. This presents a problem for physicians: Because there...
Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine When Co-Administered with Tetanus-Reduced Diphtheria-Acellular Pertussis and Quadrivalent Meningococcal Conjugate Vaccines in Healthy Adolescents: Results from a Randomized, Observer-Blind, Controlled Trial.
Vaccines against human papillomavirus (HPV), tetanus, diphtheria, pertussis (Tdap) and Neisseria meningitidis are widely recommended in adolescents. A phase-4 observer-blind study was performed to inv...
Quadrivalent meningococcal conjugate vaccines (MenACWY) have been recommended routinely for adolescents since 2005; in 2015, serogroup B meningococcal (MenB) vaccines were recommended for persons aged...
A vaccine consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and whole-cell PERTUSSIS VACCINE. The vaccine protects against diphtheria, tetanus, and whooping cough.
The formaldehyde-inactivated toxin of Corynebacterium diphtheriae. It is generally used in mixtures with TETANUS TOXOID and PERTUSSIS VACCINE; (DTP); or with tetanus toxoid alone (DT for pediatric use and Td, which contains 5- to 10-fold less diphtheria toxoid, for other use). Diphtheria toxoid is used for the prevention of diphtheria; DIPHTHERIA ANTITOXIN is for treatment.
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
Combined vaccines consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and an acellular form of PERTUSSIS VACCINE. At least five different purified antigens of B. pertussis have been used in various combinations in these vaccines.
A species of gram-negative, aerobic BACTERIA. It is a commensal and pathogen only of humans, and can be carried asymptomatically in the NASOPHARYNX. When found in cerebrospinal fluid it is the causative agent of cerebrospinal meningitis (MENINGITIS, MENINGOCOCCAL). It is also found in venereal discharges and blood. There are at least 13 serogroups based on antigenic differences in the capsular polysaccharides; the ones causing most meningitis infections being A, B, C, Y, and W-135. Each serogroup can be further classified by serotype, serosubtype, and immunotype.
A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. It creates immunity but does not cause the disease. There are several differnt types of vaccine avalable; Killed microorganisms; which s...
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...
An assay is an analytic procedure for qualitatively assessing or quantitatively measuring the presence or amount or the functional activity of a target entity. This can be a drug or biochemical substance or a cell in an organism or organic sample. ...