At a glance
ClinicalIndex Comparison Record- ✓Age 56 years or older at enrollment
- ✓Intending to go on Hajj or Umrah pilgrimage (not within 10–12 months after vaccination)
- ✓Able to attend all scheduled visits and comply with trial procedures
- ✓Written informed consent obtained
- ✕Any prior meningococcal vaccination (serogroups A, B, C, W, or Y, any formulation)
- ✕History of meningococcal infection confirmed clinically, serologically, or microbiologically
- ✕Known or suspected congenital or acquired immunodeficiency
- ✕Immunosuppressive therapy within past 6 months (chemotherapy, radiation, or long-term systemic corticosteroids for >2 consecutive weeks in past 3 months)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older
In Brief
A Phase 3 clinical trial evaluating Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine for Healthy Volunteers (Meningococcal Infection). Completed, enrolled 290 participants across 3 sites in 2 countries.
Detailed Summary
The primary objectives of this study are: * To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of MenACYW conjugate vaccine * To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using human complement (hSBA) before and after a single dose of MenACYW conjugate vaccine * To describe the antibody responses against tetanus toxoid at baseline and after a single dose of MenACYW conjugate vaccine * To describe the safety profile of a single dose of MenACYW conjugate vaccine
Study Details
Timeline
Interventions
Pharmaceutical form: Solution for injection Route of administration: Intramuscular