At a glance
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Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
In Brief
A Phase 3 clinical trial evaluating Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, and 9 other interventions for Healthy Volunteers (Meningococcal Infection). Completed, enrolled 950 participants across 47 sites in 2 countries.
Detailed Summary
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age. The secondary objectives of the study are: * To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.
Study Details
Timeline
Interventions
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL