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

PHASE2TerminatedINTERVENTIONAL
Enrollment

326

Participants

Timeline

Start Date

November 26, 2020

Primary Completion Date

September 15, 2022

Study Completion Date

September 15, 2022

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

Trial Locations (21)

11527

P. & A. Kyriakou Children's Hospital, Athens

12462

"University General Hospital ATTIKON", Athens

15706

Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela

28009

Hospital General Universitario Gregorio Marañón, Madrid

28040

Hospital Universitario Clinico San Carlos, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28938

Hospital Universitario HM Puerta del Sur, Móstoles

29015

Grupo Pediatrico Uncibay, Málaga

41012

Instituto Hispalense de Pediatria, Seville

41013

Hospital Universitario Virgen Del Rocio, Seville

46020

FISABIO, Valencia

46022

Centro de Salud la Serreria II, Valencia

46024

Centro de Salud Nazaret, Valencia

46183

Centro de Salud L'Eliana, L'Eliana

46200

Centro de Salud de Paiporta, Paiporta

54642

"Ippokratio General Hospital of Thessaloniki", Thessaloniki

68161

Dr. med Falko Panzer Praxis fuer Kinder und Jugendliche, Mannheim

08916

Hospital Universitari Germans Trias i Pujol, Badalona

09006

Hospital Universitario de Burgos, Burgos

04120

Hospital Vithas Virgen del Mar, Almería

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY