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Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, and Children in India and Healthy Adolescents and Children in the Republic of South Africa

2019-11-03 15:10:59 | BioPortfolio

Summary

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)

Description

Study duration per participant is approximately 31 to 45 days

Study Design

Conditions

Healthy Volunteers (Meningococcal Infection)

Intervention

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

Status

Not yet recruiting

Source

Sanofi

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-03T15:10:59-0500

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Medical and Biotech [MESH] Definitions

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.

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