Immunology and Safety of Menactra in Children in Saudi Arabia
Summary
This study will be conducted among children in Saudi Arabia who previously received two doses of A, C, Y, W 135 polysaccharide vaccine before the age of 2 years, and in meningococcal vaccine-naïve children (Control Group). This study will evaluate the administration of Menactra® in terms of their serum bactericidal antibody and total and serogroup-specific antibody responses for the two study groups. Safety of Menactra vaccine will be described
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Meningitis
Intervention
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate, Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Location
AlKhaleej
Qassim
Saudi Arabia
Status
Completed
Source
Sanofi-Aventis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00539032
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Diphtheria Toxoid
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.
Diphtheria-tetanus-pertussis Vaccine
A vaccine consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and whole-cell PERTUSSIS VACCINE. The vaccine protects against diphtheria, tetanus, and whooping cough.
Diphtheria-tetanus Vaccine
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.
Diphtheria-tetanus-acellular Pertussis Vaccines
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.
Vaccines, Conjugate
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.
Clinical Trials
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...
The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary O...
Immunogenicity and Safety of Menactra Vaccine in Adolescents in Saudi Arabia
This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine, this s...
Safety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination...
Dose Comparison Study of Menactra® in US Children
To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children. Primary Objective: To assess, by age group, the immune response to Me...
PubMed Articles
In the United States, co-administration of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine and tetravalent meningococcal conjugate vaccine (MCV4) is recommended in ado...
Prevention and control of meningococcal disease.
Meningococcal disease describes the spectrum of infections caused by Neisseria meningiditis, including meningitdis, bacteremia, and bacteremic pneumonia. Two quadrivalent meningococcal polysaccharide-...
In April 2011, the Food and Drug Administration approved the use of a quadrivalent meningococcal conjugate vaccine (MenACWY-D) (Menactra, Sanofi Pasteur) as a 2-dose primary series among children aged...
Relative stability of meningococcal serogroup A and X polysaccharides.
Prior to the introduction of the MenAfriVac™ serogroup A glycoconjugate vaccine in September 2010, serogroup A was the major epidemic disease-causing meningococcal serogroup in the African meningiti...
BACKGROUND: In response to increased case numbers of meningococcal group C disease, catch-up vaccination strategies have been shown to be successful. This paper describes the results of a repeat vacci...
