NCT05082285

A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants

A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 724 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 55 Days – 89 Days
• Healthy volunteers: Accepted

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 (MenABCWY-2Gen) 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.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MenABCWY-2Gen low dose vaccine	MenABCWY-2Gen low dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and study Part II.
COMBINATION_PRODUCT	MenABCWY-2Gen high dose vaccine	MenABCWY-2Gen high dose vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 2 and study Part II.
COMBINATION_PRODUCT	MenABCWY-1Gen vaccine	MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part II.
COMBINATION_PRODUCT	MenB vaccine	MenB vaccine is administered intramuscularly in the upper thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.
COMBINATION_PRODUCT	MenACWY-TT vaccine	MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg as 3 doses to participants in study Part I, Step 1 and Step 2 and study Part II.

Timeline

• Start date: 2021-11-29
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2021-10-18
• Last updated: 2025-05-18

Locations

33 sites across 8 countries: Dominican Republic, Finland, Germany, Honduras, Poland, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study