Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

November 5, 2024

Primary Completion Date

April 21, 2027

Study Completion Date

May 17, 2027

Conditions
Meningococcal ImmunizationHealthy Volunteers
Interventions
BIOLOGICAL

Pentavalent Meningococcal ABCYW vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

BIOLOGICAL

MenACYW conjugate vaccine

Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM)

BIOLOGICAL

MenACYW conjugate vaccine

Pharmaceutical form: Powder and solvent for injectable solution in a pre-filled syringe Route of administration: Intramuscular (IM)

BIOLOGICAL

Meningococcal group B vaccine

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

DRUG

Paracetamol

Pharmaceutical form:Suspension-Route of administration:oral

BIOLOGICAL

DTap-HepB-IPV-Hib vaccine

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

BIOLOGICAL

DTap-HepB-IPV-Hib vaccine

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

BIOLOGICAL

DTap-HepB-IPV-Hib vaccine

Pharmaceutical form: Oral solution in tube Route of administration: oral

BIOLOGICAL

Rotavirus vaccine

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

BIOLOGICAL

Pneumococcal 13-valent conjugate vaccine

Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

Trial Locations (38)

2650

RECRUITING

Investigational Site Number : 2080002, Hvidovre

5000

RECRUITING

Investigational Site Number : 2080003, Odense

11101

RECRUITING

Investigational Site Number : 3400002, Tegucigalpa

RECRUITING

Investigational Site Number : 3400003, Tegucigalpa

18000

RECRUITING

Investigational Site Number : 2030008, Prague

21104

RECRUITING

Investigational Site Number : 3400001, San Pedro Sula

28041

RECRUITING

Investigational Site Number : 7240009, Madrid

28938

RECRUITING

Investigational Site Number : 7240004, Madrid

33100

RECRUITING

Investigational Site Number : 2460007, Tampere

38448

RECRUITING

Investigational Site Number : 2760003, Wolfsburg

41013

RECRUITING

Investigational Site Number : 7240007, Seville

41236

RECRUITING

Investigational Site Number : 2760009, Mönchengladbach

47799

RECRUITING

Investigational Site Number : 2760005, Krefeld

50354

RECRUITING

Investigational Site Number : 2760006, Hürth

RECRUITING

Investigational Site Number : 2760007, Hürth

60100

RECRUITING

Investigational Site Number : 2460002, Seinäjoki

76863

RECRUITING

Investigational Site Number : 2760008, Herxheim

83471

RECRUITING

Investigational Site Number : 2760004, Schönau am Königssee

90220

RECRUITING

Investigational Site Number : 2460004, Oulu

80810-100

RECRUITING

Nelson Rosario Medicos Associados S/S Site Number : 0760004, Curitiba

30130-100

RECRUITING

UFMG Site Number : 0760001, Belo Horizonte

700 30

RECRUITING

Investigational Site Number : 2030004, Ostrava

301 00

RECRUITING

Investigational Site Number : 2030007, Pilsen

02230

RECRUITING

Investigational Site Number : 2460006, Espoo

00100

RECRUITING

Investigational Site Number : 2460001, Helsinki

00290

RECRUITING

Investigational Site Number : 2460008, Helsinki

04400

RECRUITING

Investigational Site Number : 2460005, Järvenpää

85-090

RECRUITING

Investigational Site Number : 6160006, Bydgoszcz

55-100

RECRUITING

Investigational Site Number : 6160005, Trzebnica

02-647

RECRUITING

Investigational Site Number : 6160003, Warsaw

41-103

RECRUITING

Investigational Site Number : 6160004, Siemianowice Śląskie

91-347

RECRUITING

Investigational Site Number : 6160001, Lodz

00-710

RECRUITING

Investigational Site Number : 6160002, Warsaw

SW17 0QT

RECRUITING

Investigational Site Number : 8260009, London

BD9 6RJ

RECRUITING

Investigational Site Number : 8260006, Bradford

EX2 5DW

RECRUITING

Investigational Site Number : 8260004, Exeter

SO16 6YD

RECRUITING

Investigational Site Number : 8260010, Southampton

E1 1 FR

RECRUITING

Investigational Site Number : 8260007, Whitechapel

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY