Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (NCT06647407) — Spain Trial Details

Condition(s) studied

Meningococcal ImmunizationHealthy Volunteers

Investigational drug(s) / intervention(s)

Pentavalent Meningococcal ABCYW vaccineMenACYW conjugate vaccine →MenACYW conjugate vaccine →Meningococcal group B vaccine →Paracetamol →DTap-HepB-IPV-Hib vaccine →DTap-HepB-IPV-Hib vaccine →DTap-HepB-IPV-Hib vaccine →Rotavirus vaccinePneumococcal 13-valent conjugate vaccine

Pentavalent Meningococcal ABCYW vaccine: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

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

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

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

Paracetamol: Pharmaceutical form:Suspension-Route of administration:oral

DTap-HepB-IPV-Hib vaccine: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

DTap-HepB-IPV-Hib vaccine: Pharmaceutical form: Oral solution in tube Route of administration: oral

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

Pneumococcal 13-valent conjugate vaccine: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)

Study 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

Sex

ALL

Min age

56 Days

Max age

9 Years

Healthy volunteers

Accepted

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 outcome measure(s)

Number of participants with unsolicited immediate adverse events (AEs) — Within 30 minutes after each vaccination
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants with solicited injection site reactions or systemic reactions — Within 7 days after each vaccination
Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF
Number of participants with unsolicited AEs — Within 30 days after each vaccination
Unsolicited AEs other than solicited reactions
Number of participants with serious adverse events (SAEs) — Throughout the study, from first visit until 180 days after the last vaccination
SAEs (including adverse events of special interest \[AESIs\]) reported throughout the study
hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 30 days after the second and third dose in infant participants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
hSBA titers ≥ 1:8 post-vaccination (post-second and third dose)
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second and third dose in infant participants — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
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
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 — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
Geometric mean titers (pre-dose and post-second and third dose)
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 — 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 — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
hSBA titers ≥ 1:4 for reference MenB strains
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 — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
hSBA titers ≥ 1:8 for reference MenB strains
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 — For Stage 3: Day 1, Day 91, Day 301-361, Day 331-391
Seroresponse defined as a 4-fold increase in hSBA titers
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 — Day 01, Day 91, Day 181 and Day 211 (for Stage 3)
Geometric mean titers (pre-dose and post-second dose) for the reference MenB strains
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 — 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 — 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 — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
hSBA titers ≥ 1:8 for serogroups A, C, W, and Y
hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
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
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 — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
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 — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
Seroresponse defined as a 4-fold increase in hSBA titers
Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) in children and toddlers — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
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 — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
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 — For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

Trial sites (39)

Facility	City	Region
Hospital das Clínicas da Universidade Federal de Minas Gerais- Site Number : 0760001	Belo Horizonte	Minas Gerais
Private Practice - Dr. Nelson Rosário- Site Number : 0760004	Curitiba	Paraná
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
Investigational Site Number : 6160005	Trzebnica	Lower Silesian Voivodeship
Investigational Site Number : 6160001	Lodz	Lódzkie
Investigational Site Number : 6160003	Warsaw	Masovian Voivodeship
Investigational Site Number : 6160002	Warsaw	Masovian Voivodeship
Investigational Site Number : 6160004	Siemianowice Śląskie	Silesian Voivodeship
Investigational Site Number : 7240007	Seville	Sevilla
Investigational Site Number : 7240009	Madrid	Spain
Investigational Site Number : 7240004	Madrid	Spain
Investigational Site Number : 8260004	Exeter	Devon
Investigational Site Number : 8260007	London	England
Investigational Site Number : 8260009	London	England
Investigational Site Number : 8260010	Southampton	Hampshire

More Sanofi Pasteur, a Sanofi Company trials in Spain

Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia Active, not recruiting

Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers Active, not recruiting

Other trials for the same condition

Comparison of the Effect of Different Inspiratory Loads on Diaphragmatic Function in Healthy Individuals Active, not recruiting

Eco-guided Neuromodulation of the Femoral Nerve on the Performance of Amateur Athletes. Recruiting

Effects of Peripheral Somatosensory Stimulation Via Mechanical Pressure on Lower Limb Muscle Strength in Healthy Subjects. Starting soon

To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects Active, not recruiting

Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers Active, not recruiting