Clinical trial NCT06647407: Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Meningococcal Immunization
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-10-17
Enrollment: 750
Sex: ALL
Minimum age (years): 56
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with unsolicited immediate adverse events (AEs)
timeFrame: Within 30 minutes after each vaccination
measure: Number of participants with solicited injection site reactions or systemic reactions
timeFrame: Within 7 days after each vaccination
measure: Number of participants with unsolicited AEs
timeFrame: Within 30 days after each vaccination
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Throughout the study, from first visit until 180 days after the last vaccination
measure: hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 30 days after the second and third dose in infant participants
timeFrame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
measure: hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second and third dose in infant participants
timeFrame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
measure: 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
timeFrame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
measure: 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
timeFrame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
measure: 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
timeFrame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
measure: 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
timeFrame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
measure: 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
timeFrame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
measure: 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
timeFrame: Day 01, Day 91, Day 181 and Day 211 (for Stage 3)
measure: 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
timeFrame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
measure: 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
timeFrame: For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
measure: hSBA meningococcal serogroups A, C, W, and Y antibody titers in children and toddlers
timeFrame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
measure: hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse in children and toddlers
timeFrame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
measure: Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose children and toddlers
timeFrame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
measure: Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y children and toddlers
timeFrame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
measure: Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 in children and toddlers
timeFrame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
measure: Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 in children and toddlers
timeFrame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
measure: hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse in children and toddlers
timeFrame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
measure: Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) in children and toddlers
timeFrame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
measure: Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all of serogroup B (reference MenB strains) in children and toddlers
timeFrame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
measure: Percentage of participants with hSBA titers less than the lower limit of quantification (LLOQ) against all serogroup B (reference MenB strains) in children and toddlers
timeFrame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Secondary outcomes:
measure: hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse in children, toddler and infant participants
timeFrame: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391
measure: Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:4 in children, toddler and infant participants
timeFrame: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391
measure: Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:8 in children, toddler and infant participants
timeFrame: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391
measure: Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) in children, toddler and infant participants
timeFrame: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391
measure: Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ each and all additional MenB strains in children, toddler and infant participants
timeFrame: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391
measure: Percentage of participants with hSBA composite seroresponse titers less than LLOQ all additional MenB strains in children, toddler and infant participants
timeFrame: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Nelson Rosario Medicos Associados S/S Site Number : 0760004
state: Paraná
city: Belo Horizonte
country: Brazil
facility: UFMG Site Number : 0760001
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2030004
city: Plzeň
country: Czechia
facility: Investigational Site Number : 2030007
city: Praha 8
country: Czechia
facility: Investigational Site Number : 2030008
city: Hvidovre
country: Denmark
facility: Investigational Site Number : 2080002
city: Odense
country: Denmark
facility: Investigational Site Number : 2080003
city: Espoo
country: Finland
facility: Investigational Site Number : 2460006
city: Helsinki
country: Finland
facility: Investigational Site Number : 2460001
city: Helsinki
country: Finland
facility: Investigational Site Number : 2460008
city: Järvenpää
country: Finland
facility: Investigational Site Number : 2460005
city: Oulu
country: Finland
facility: Investigational Site Number : 2460004
city: Seinäjoki
country: Finland
facility: Investigational Site Number : 2460002
city: Tampere
country: Finland
facility: Investigational Site Number : 2460007
city: Herxheim
country: Germany
facility: Investigational Site Number : 2760008
city: Huerth
country: Germany
facility: Investigational Site Number : 2760006
city: Hürth
country: Germany
facility: Investigational Site Number : 2760007
city: Krefeld
country: Germany
facility: Investigational Site Number : 2760005
city: Mönchengladbach
country: Germany
facility: Investigational Site Number : 2760009
city: Schönau Am Königssee
country: Germany
facility: Investigational Site Number : 2760004
city: Wolfsburg
country: Germany
facility: Investigational Site Number : 2760003
city: San Pedro Sula
country: Honduras
facility: Investigational Site Number : 3400001
city: Tegucigalpa
country: Honduras
facility: Investigational Site Number : 3400002
city: Tegucigalpa
country: Honduras
facility: Investigational Site Number : 3400003
city: Trzebnica
country: Poland
facility: Investigational Site Number : 6160005
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Investigational Site Number : 6160006
state: Kujawsko-pomorskie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160003
state: Mazowieckie
city: Siemianowice Slaskie
country: Poland
facility: Investigational Site Number : 6160004
state: Slaskie
city: Lodz
country: Poland
facility: Investigational Site Number : 6160001
city: Warszawa
country: Poland
facility: Investigational Site Number : 6160002
city: Seville
country: Spain
facility: Investigational Site Number : 7240007
state: Sevilla
city: Madrid
country: Spain
facility: Investigational Site Number : 7240009
city: Madrid
country: Spain
facility: Investigational Site Number : 7240004
city: London
country: United Kingdom
facility: Investigational Site Number : 8260009
state: London, City Of
city: Bradford
country: United Kingdom
facility: Investigational Site Number : 8260006
city: Exeter
country: United Kingdom
facility: Investigational Site Number : 8260004
city: Southampton
country: United Kingdom
facility: Investigational Site Number : 8260010
city: Whitechapel
country: United Kingdom
facility: Investigational Site Number : 8260007
Study officials:
References: