This study evaluated the immunogenicity and safety of a single dose of MenQuadfi® administered as a booster vaccine in toddlers 12 - 23 months of age in Argentina who had been primed with at least 1 dose of the quadrivalent meningococcal conjugate vaccines Nimenrix® or Menveo® during infancy to protect against invasive meningococcal disease (IMD). Participants received a single dose of MenQuadfi® at Visit 1. Participants provided 2 blood samples, one at D01 (Visit 1) pre-vaccination and another at D31 (Visit 2) post-vaccination for the immunogenicity assessments. Study included 2 visits at D01 (Visit 1) and at D31 (Visit 2), and 1 Telephone call (TC) for safety follow-up at D09 post-study vaccination.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post vaccination on Day 1)
Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA)
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid
Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Timeframe: Up to 30 minutes post-vaccination on Day 1
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Timeframe: Up to 7 days post-vaccination on Day 1
Number of Participants With Unsolicited Adverse Events
Timeframe: Up to 30 days post-vaccination on Day 1
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Timeframe: From vaccination (Day 1) up to 30 days post vaccination, 31 days