At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants
In Brief
A Phase 2 clinical trial evaluating MenACWY-7B low dose vaccine, MenACWY-7B high dose vaccine, and 3 other interventions for Infections, Meningococcal. Completed, enrolled 726 participants across 33 sites in 8 countries.
Detailed Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenACWY-7b) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.
Study Details
Timeline
Arms & Interventions
Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301.
Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301.
Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301.
Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301.
Interventions
MenACWY-7B low dose vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenACWY-7B high dose vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenB vaccine is administered intramuscularly in the upper thigh region of the right leg.
MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg.