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.
Age range
12 Months – 23 Months
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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