Clinical Trials Logo

Clinical Trial Summary

The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW Conjugate vaccine) 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 MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations. - To describe the immunogenicity profile of MenACYW Conjugate 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 MenACYW Conjugate vaccine.


Clinical Trial Description

Participants received study vaccinations beginning at age 2, 6, 12, or 15 months, depending on the assigned schedule in their randomized groups. All participants underwent safety and immunogenicity assessments according to the schedule for their assigned group. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01049035
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date December 16, 2009
Completion date February 13, 2012

See also
  Status Clinical Trial Phase
Withdrawn NCT03445416 - Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men N/A
Completed NCT02526394 - Pertussis and Meningitis C Concomitant Vaccination in Adolescents Phase 4
Completed NCT01442675 - Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine Phase 2
Completed NCT00539032 - Immunology and Safety of Menactra® in Children in Saudi Arabia Phase 3
Terminated NCT00428051 - Colombia Epidemiologic Surveillance Study N/A
Recruiting NCT05496673 - Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda N/A
Completed NCT02003495 - Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine Phase 3
Recruiting NCT00901602 - Lebanese Interhospital Pneumococcal Surveillance Program
Completed NCT00850603 - Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune® Phase 4
Completed NCT02591290 - Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects Phase 4
Completed NCT03112031 - Treatment With Tamoxifen in Cryptococcal Meningitis Phase 2
Completed NCT02881957 - Hypovitaminosis D in Neurocritical Patients Phase 2/Phase 3
Completed NCT06334796 - Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology Early Phase 1
Completed NCT03378258 - Petechiae In Children (PIC) Study: Defining A Clinical Decision Rule for The Management Of Fever and Non-Blanching Rashes In Children Including The Role Of Point Of Care Testing For Procalcitonin & Neisseria Meningitidis DNA.
Recruiting NCT05637645 - Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section N/A
Completed NCT02841254 - Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies N/A
Completed NCT02003313 - Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine Phase 3
Recruiting NCT01619462 - Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children Phase 3
Completed NCT01239043 - Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination Phase 2
Completed NCT00495690 - Impact of Daily Zinc Supplementation to Infants Born With Low Birth Weight on Death and Severe Disease Phase 3