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ACTIVE NOT RECRUITING

NCT06647407

PHASE1/PHASE2

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

Sponsor: Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3). Study details include: The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.

Official title: A Parallel-group Prevention, Phase II, Partially Blinded, Multi-stage Study to Investigate the Immunogenicity and Safety of Pentavalent Meningococcal ABCYW Vaccine Formulations Compared With Licensed Meningococcal Vaccines When Administered Alone in Healthy Children (2 to 9 Years of Age) or Concomitantly With Routine Pediatric Vaccines in Toddlers (12 to 15 Months of Age) and Infants (2 Months of Age).

Key Details

Gender

All

Age Range

56 Days - 9 Years

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2024-11-05

Completion Date

2027-05-17

Last Updated

2026-01-20

Healthy Volunteers

Yes

Conditions

Meningococcal Immunization Healthy 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)

Inclusion Criteria: * Aged 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3) on the day of inclusion * For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 Kg or born after a gestation period of period above 28 (\> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 Kg and in both cases medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the investigator Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months or since birth for infants; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for and infants) * History of any meningitis infection, confirmed either clinically, serologically, or microbiologically * At high risk of meningococcal infection during the study * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances * Individual with active tuberculosis * History of Guillain-Barré syndrome * For Stage 3 infants: History of intussusception * Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with an investigational or marketed vaccine * For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (39)

Hospital das Clínicas da Universidade Federal de Minas Gerais- Site Number : 0760001

Belo Horizonte, Minas Gerais, Brazil

Private Practice - Dr. Nelson Rosário- Site Number : 0760004

Curitiba, Paraná, Brazil

Investigational Site Number : 2030003

Jindřichův Hradec, Czechia

Investigational Site Number : 2030004

Ostrava, Czechia

Investigational Site Number : 2030007

Pilsen, Czechia

Investigational Site Number : 2030008

Prague, Czechia

Investigational Site Number : 2030009

Prague, Czechia

Investigational Site Number : 2080002

Hvidovre, Denmark

Investigational Site Number : 2080003

Odense, Denmark

Investigational Site Number : 2460006

Espoo, Finland

Investigational Site Number : 2460001

Helsinki, Finland

Investigational Site Number : 2460008

Helsinki, Finland

Investigational Site Number : 2460005

Jarvenpaa, Finland

Investigational Site Number : 2460004

Oulu, Finland

Investigational Site Number : 2460002

Seinäjoki, Finland

Investigational Site Number : 2460007

Tampere, Finland

Investigational Site Number : 2760008

Herxheim, Germany

Investigational Site Number : 2760006

Hürth, Germany

Investigational Site Number : 2760007

Hürth, Germany

Investigational Site Number : 2760005

Krefeld, Germany

Investigational Site Number : 2760009

Mönchengladbach, Germany

Investigational Site Number : 2760004

Schönau am Königssee, Germany

Investigational Site Number : 2760003

Wolfsburg, Germany

Investigational Site Number : 3400001

San Pedro Sula, Honduras

Investigational Site Number : 3400002

Tegucigalpa, Honduras

Investigational Site Number : 3400003

Tegucigalpa, Honduras

Investigational Site Number : 6160006

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Investigational Site Number : 6160005

Trzebnica, Lower Silesian Voivodeship, Poland

Investigational Site Number : 6160001

Lodz, Lódzkie, Poland

Investigational Site Number : 6160003

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 6160002

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 6160004

Siemianowice Śląskie, Silesian Voivodeship, Poland

Investigational Site Number : 7240007

Seville, Sevilla, Spain

Investigational Site Number : 7240009

Madrid, Spain

Investigational Site Number : 7240004

Madrid, Spain

Investigational Site Number : 8260004

Exeter, Devon, United Kingdom

Investigational Site Number : 8260007

London, England, United Kingdom

Investigational Site Number : 8260009

London, England, United Kingdom

Investigational Site Number : 8260010

Southampton, Hampshire, United Kingdom