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

Phase 2Active Not RecruitingNCT06647407

Sanofi Pasteur, a Sanofi Company750 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

750

Conditions

Meningococcal Immunization Healthy Volunteers

Interventions

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

MenACYW conjugate vaccineBIOLOGICAL

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

MenACYW conjugate vaccineBIOLOGICAL

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

Meningococcal group B vaccineBIOLOGICAL

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

ParacetamolDRUG

Pharmaceutical form:Suspension-Route of administration:oral

DTap-HepB-IPV-Hib vaccineBIOLOGICAL

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

DTap-HepB-IPV-Hib vaccineBIOLOGICAL

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

DTap-HepB-IPV-Hib vaccineBIOLOGICAL

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

Rotavirus vaccineBIOLOGICAL

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

Pneumococcal 13-valent conjugate vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 56 DaysMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with unsolicited immediate adverse events (AEs)

Unsolicited systemic AEs that occur within 30 minutes after vaccination

Time frame: Within 30 minutes after each vaccination

Number of participants with solicited injection site reactions or systemic reactions

Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF

Time frame: Within 7 days after each vaccination

Number of participants with unsolicited AEs

Unsolicited AEs other than solicited reactions

Time frame: Within 30 days after each vaccination

Number of participants with serious adverse events (SAEs)

SAEs (including adverse events of special interest \[AESIs\]) reported throughout the study

Time frame: Throughout the study, from first visit until 180 days after the last vaccination

hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 30 days after the second and third dose in infant participants

hSBA titers ≥ 1:8 post-vaccination (post-second and third dose)

Time frame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second and third dose in infant participants

Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or or postvaccination titers ≥ 4 times the lower limit of quantification (LLOQ) for participants with a pre-vaccination titer ≤ LLOQ or a post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer ≥ LLOQ

Time frame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second and third dose in infant participants

Geometric mean titers (pre-dose and post-second and third dose)

Time frame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y pre-dose and 1 month after the second and third dose in infant participants

Time frame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose and 1 month after second dose of vaccination against serogroup B, before and 30 days after third dose in infants

hSBA titers ≥ 1:4 for reference MenB strains

Time frame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infants

hSBA titers ≥ 1:8 for reference MenB strains

Time frame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants

Seroresponse defined as a 4-fold increase in hSBA titers

Time frame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose and 1 month after the second dose of vaccination against serogroup B, before and 30 days after third dose in infant participants

Geometric mean titers (pre-dose and post-second dose) for the reference MenB strains

Time frame: Day 01, Day 91, Day 181 and Day 211 (for Stage 3)

Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (ref. MenB strains) predose and 1 month after 2nd dose against serogroup B, before and 30 days after 3rd dose in infants

Time frame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

Percentage of participants with hSBA titers less than LLOQ against all serogroup B (ref. MenB strains) pre-dose and 1 month after the 2nd dose of vaccination against serogroup B, before and 30 days after 3rd dose in infants

Time frame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391

hSBA meningococcal serogroups A, C, W, and Y antibody titers in children and toddlers

hSBA titers ≥ 1:8 for serogroups A, C, W, and Y