MedTrace Logo

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

NCT05082285 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 724

Last updated 2025-05-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-29
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • Dominican Republic
  • Finland
  • Germany
  • Honduras
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05082285 on ClinicalTrials.gov