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A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants

NCT04645966 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2024-03-25

Study results available
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Summary

The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.

Conditions

  • Meningococcal Vaccine

Interventions

BIOLOGICAL

MenABCWY

Neisseria meningitis groups A, B, C W, and Y vaccine

BIOLOGICAL

Bivalent rLP2086 (60-µg Dose)

Trumenba (half dose) - Meningococcal Group B vaccine

BIOLOGICAL

Bivalent rLP2086 (120-µg Dose)

Trumenba - Meningococcal Group B vaccine

BIOLOGICAL

Bexsero

Bexsero - Meningococcal Group B vaccine

DRUG

Prophylactic Liquid Paracetamol (PLP)

PLP administration during primary vaccinations 1 and 2

BIOLOGICAL

Nimenrix

Nimenrix - Meningococcal Group A, C, W and Y vaccine

OTHER

Placebo

Normal Saline

DRUG

Scheduled Liquid Paracetamol (SLP)

SLP administration after primary vaccinations 1 and 2.

DRUG

Therapeutic Liquid Paracetamol (TLP)

TLP administration after primary vaccinations 1 and 2

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
2 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-26
Primary Completion
2022-09-15
Completion
2022-09-15

Countries

  • Germany
  • Greece
  • Spain

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 NCT04645966 on ClinicalTrials.gov