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

NCT06647407 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: VAN000132023-510465-10
• Study Type: interventional
• Target: 750
• Locations: 9 countries
• Sites: 39

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.

Conditions

Meningococcal Immunization; Healthy Volunteers

Outcome Measures

Primary Outcomes (24)

• Number of participants with unsolicited immediate adverse events (AEs)

  Unsolicited systemic AEs that occur within 30 minutes after vaccination

  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

  Within 7 days after each vaccination

• Number of participants with unsolicited AEs

  Unsolicited AEs other than solicited reactions

  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

  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)

  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

  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)

  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

  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

  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

  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

  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

  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

  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

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

  For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

• hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse in children and toddlers

  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

  For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

• 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

  Seroresponse defined as a 4-fold increase in hSBA titers

  For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211

• 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

Secondary Outcomes (6)

• hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse in children, toddler and infant participants

  Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

• Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:4 in children, toddler and infant participants

  Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

• Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) ≥ 1:8 in children, toddler and infant participants

  Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

• Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) in children, toddler and infant participants

  Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

• 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

  Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391

Study Arms (9)

Stage 1: MenPenta vaccine formulation 1

EXPERIMENTAL

MenPenta vaccine formulation 1, children 2-9 years of age

Biological: Pentavalent Meningococcal ABCYW vaccine

Stage 1: MenPenta vaccine formulation 2

EXPERIMENTAL

MenPenta vaccine formulation 2, children 2-9 years of age

Biological: Pentavalent Meningococcal ABCYW vaccine

Stage 1: vaccine comparator(s)

ACTIVE COMPARATOR

Comparator vaccines: Bexsero + MenQuadfi, children 2-9 years of age

Biological: MenACYW conjugate vaccine; Biological: Meningococcal group B vaccine

Stage 2: MenPenta vaccine formulation 1

EXPERIMENTAL

MenPenta vaccine formulation 1 + routine vaccines, toddlers 12-15 months of age

Biological: Pentavalent Meningococcal ABCYW vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine

Stage 2: MenPenta vaccine formulation 2

EXPERIMENTAL

MenPenta vaccine formulation 2 + routine vaccines, toddlers 12-15 months of age

Biological: Pentavalent Meningococcal ABCYW vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine

Stage 2: vaccine comparator(s)

ACTIVE COMPARATOR

Comparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age

Biological: MenACYW conjugate vaccine; Biological: Meningococcal group B vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine

Stage 3: MenPenta vaccine formulation 1

EXPERIMENTAL

MenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age

Biological: Pentavalent Meningococcal ABCYW vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Rotavirus vaccine; Biological: Pneumococcal 13-valent conjugate vaccine

Stage 3: MenPenta vaccine formulation 2

EXPERIMENTAL

MenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age

Biological: Pentavalent Meningococcal ABCYW vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Rotavirus vaccine; Biological: Pneumococcal 13-valent conjugate vaccine

Stage 3: vaccine comparator(s)

ACTIVE COMPARATOR

Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age

Biological: MenACYW conjugate vaccine; Biological: Meningococcal group B vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Rotavirus vaccine; Biological: Pneumococcal 13-valent conjugate vaccine

Interventions

Pentavalent Meningococcal ABCYW vaccine BIOLOGICAL

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

Also known as: MenPenta

Stage 1: MenPenta vaccine formulation 1; Stage 1: MenPenta vaccine formulation 2; Stage 2: MenPenta vaccine formulation 1; Stage 2: MenPenta vaccine formulation 2; Stage 3: MenPenta vaccine formulation 1; Stage 3: MenPenta vaccine formulation 2

MenACYW conjugate vaccine BIOLOGICAL

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

Also known as: MenQuadfi®

Stage 1: vaccine comparator(s); Stage 2: vaccine comparator(s)

Meningococcal group B vaccine BIOLOGICAL

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

Also known as: Bexsero®

Stage 1: vaccine comparator(s); Stage 2: vaccine comparator(s); Stage 3: vaccine comparator(s)

Paracetamol DRUG

Pharmaceutical form:Suspension-Route of administration:oral

Stage 2: MenPenta vaccine formulation 1; Stage 2: MenPenta vaccine formulation 2; Stage 2: vaccine comparator(s); Stage 3: MenPenta vaccine formulation 1; Stage 3: MenPenta vaccine formulation 2; Stage 3: vaccine comparator(s)

DTap-HepB-IPV-Hib vaccine BIOLOGICAL

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

Also known as: Hexyon®

Stage 2: MenPenta vaccine formulation 1; Stage 2: MenPenta vaccine formulation 2; Stage 2: vaccine comparator(s); Stage 3: MenPenta vaccine formulation 1; Stage 3: MenPenta vaccine formulation 2; Stage 3: vaccine comparator(s)

Rotavirus vaccine BIOLOGICAL

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

Also known as: RotaTeq® Rotarix®

Stage 3: MenPenta vaccine formulation 1; Stage 3: MenPenta vaccine formulation 2; Stage 3: vaccine comparator(s)

Pneumococcal 13-valent conjugate vaccine BIOLOGICAL

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

Also known as: Prevnar 13®

Stage 2: MenPenta vaccine formulation 1; Stage 2: MenPenta vaccine formulation 2; Stage 2: vaccine comparator(s); Stage 3: MenPenta vaccine formulation 1; Stage 3: MenPenta vaccine formulation 2; Stage 3: vaccine comparator(s)

Eligibility Criteria

• Age: 56 Days - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (39)

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

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

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

Curitiba, Paraná, 80810-100, Brazil

Location

Investigational Site Number : 2030003

Jindřichův Hradec, 377 01, Czechia

Location

Investigational Site Number : 2030004

Ostrava, 700 30, Czechia

Location

Investigational Site Number : 2030007

Pilsen, 301 00, Czechia

Location

Investigational Site Number : 2030008

Prague, 180 00, Czechia

Location

Investigational Site Number : 2030009

Prague, 180 00, Czechia

Location

Investigational Site Number : 2080002

Hvidovre, 2650, Denmark

Location

Investigational Site Number : 2080003

Odense, 5000, Denmark

Location

Investigational Site Number : 2460006

Espoo, 02230, Finland

Location

Investigational Site Number : 2460001

Helsinki, 00100, Finland

Location

Investigational Site Number : 2460008

Helsinki, 00290, Finland

Location

Investigational Site Number : 2460005

Jarvenpaa, 04400, Finland

Location

Investigational Site Number : 2460004

Oulu, 90220, Finland

Location

Investigational Site Number : 2460002

Seinäjoki, 60100, Finland

Location

Investigational Site Number : 2460007

Tampere, 33100, Finland

Location

Investigational Site Number : 2760008

Herxheim, 76863, Germany

Location

Investigational Site Number : 2760006

Hürth, 50354, Germany

Location

Investigational Site Number : 2760007

Hürth, 50354, Germany

Location

Investigational Site Number : 2760005

Krefeld, 47799, Germany

Location

Investigational Site Number : 2760009

Mönchengladbach, 41236, Germany

Location

Investigational Site Number : 2760004

Schönau am Königssee, 83471, Germany

Location

Investigational Site Number : 2760003

Wolfsburg, 38448, Germany

Location

Investigational Site Number : 3400001

San Pedro Sula, Honduras

Location

Investigational Site Number : 3400002

Tegucigalpa, 11101, Honduras

Location

Investigational Site Number : 3400003

Tegucigalpa, 11101, Honduras

Location

Investigational Site Number : 6160006

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-090, Poland

Location

Investigational Site Number : 6160005

Trzebnica, Lower Silesian Voivodeship, 55-100, Poland

Location

Investigational Site Number : 6160001

Lodz, Lódzkie, 91-347, Poland

Location

Investigational Site Number : 6160003

Warsaw, Masovian Voivodeship, 02-647, Poland

Location

Investigational Site Number : 6160002

Warsaw, Masovian Voivodeship, 02-793, Poland

Location

Investigational Site Number : 6160004

Siemianowice Śląskie, Silesian Voivodeship, 41-103, Poland

Location

Investigational Site Number : 7240007

Seville, Sevilla, 41013, Spain

Location

Investigational Site Number : 7240009

Madrid, 28041, Spain

Location

Investigational Site Number : 7240004

Madrid, 28938, Spain

Location

Investigational Site Number : 8260004

Exeter, Devon, EX2 5DW, United Kingdom

Location

Investigational Site Number : 8260007

London, England, E1 1BB, United Kingdom

Location

Investigational Site Number : 8260009

London, England, SW17 0QT, United Kingdom

Location

Investigational Site Number : 8260010

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Links

• VAN00013 Plain Language Results Summary

MeSH Terms

Interventions

4CMenB vaccine; Acetaminophen; DTaP-IPV-HB-PRP-T vaccine; Vaxelis; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; Rotavirus Vaccines; 13-valent pneumococcal vaccine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Partially blinded (treatment assignment is blinded between the two investigational formulation groups, and open label between the investigation and the comparator group) * Laboratory personnel will be blinded to the treatment assignment * Participants, Investigators, and Site staff preparing and administering the study intervention will be unblinded between the MenPenta and comparator groups but will be blinded between the 2 MenPenta groups The Sponsor will be partially blinded. At the time of periodic data reviews, additional measures are put in place to maintain the blind of the study participants for the Sponsor staff. The data review will be conducted on the basis of blinded outputs (where data of the 2 MenPenta groups and the control group will be reviewed in aggregate, without any distinction by group). By design, the Sponsor team will have access to partially blinded data for individual participants (eg, for assessment of SAE)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): May 17, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (4); PL (6); FI (7); HO (3); BR (2); CZ (5); DK (2); DE (7); ES (3)