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A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine (TetraMen-T) in Infants and Toddlers

2014-08-27 03:16:40 | BioPortfolio

Summary

The purpose of this study is to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in order to provide an effective protein conjugate quadrivalent meningococcal vaccine in the population with the highest incidence of disease.

Objectives:

- To describe the safety profile of TetraMen-T vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.

- To describe the immunogenicity profile of TetraMen-T vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.

- To describe the immunogenicity profiles of selected licensed pediatric vaccines (Pentacel, Prevnar, M-M-RII and Varivax) when administered either concomitantly with or without TetraMen-T vaccine.

Description

Participants will receive study vaccinations beginning at age 2, 6, or 12 months, depending on the assigned schedule in their randomized groups. All participants will undergo safety and immunogenicity assessments according to the schedule for their assigned group.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Meningitis

Intervention

Meningococcal Polysaccharide Tetanus Protein Conjugate, Meningococcal Polysaccharide Tetanus Protein Conjugate, Meningococcal Polysaccharide Tetanus Protein Conjugate, Meningococcal Polysaccharide Tetanus Protein Conjugate, Meningococcal Polysaccharide Te

Location

Birmingham
Alabama
United States
35205

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:40-0400

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PubMed Articles [10053 Associated PubMed Articles listed on BioPortfolio]

Immunogenicity and safety of the quadrivalent meningococcal vaccine MenACWY-TT co-administered with a combined diphtheria-tetanus-acellular pertussis vaccine versus their separate administration in adolescents and young adults: A phase III, randomized study.

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Medical and Biotech [MESH] Definitions

Semisynthetic vaccines consisting of polysaccharide antigens from microorganisms attached to protein carrier molecules. The carrier protein is recognized by macrophages and T-cells thus enhancing immunity. Conjugate vaccines induce antibody formation in people not responsive to polysaccharide alone, induce higher levels of antibody, and show a booster response on repeated injection.

A disease caused by tetanospasmin, a powerful protein toxin produced by CLOSTRIDIUM TETANI. Tetanus usually occurs after an acute injury, such as a puncture wound or laceration. Generalized tetanus, the most common form, is characterized by tetanic muscular contractions and hyperreflexia. Localized tetanus presents itself as a mild condition with manifestations restricted to muscles near the wound. It may progress to the generalized form.

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.

A vaccine consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and whole-cell PERTUSSIS VACCINE. The vaccine protects against diphtheria, tetanus, and whooping cough.

An antitoxin used for the treatment of TETANUS.

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