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

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).

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 Overview

• Status: Active, not recruiting
• Conditions: Healthy Volunteers; Meningococcal Immunization
• Intervention / Treatment: Biological: Pentavalent Meningococcal ABCYW vaccine; Biological: MenACYW conjugate vaccine; Biological: MenACYW conjugate vaccine; Biological: Meningococcal group B vaccine; Drug: Paracetamol; Biological: DTap-HepB-IPV-Hib vaccine; Biological: DTap-HepB-IPV-Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine; Biological: Rotavirus vaccine

• Study Type: Interventional
• Enrollment (Estimated): 750
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Hospital das Clínicas da Universidade Federal de Minas Gerais- Site Number : 0760001
  • Paraná
    • Curitiba, Paraná, Brazil, 80810-100
      • Private Practice - Dr. Nelson Rosário- Site Number : 0760004
• Czechia
  • Jindřichův Hradec, Czechia, 377 01
    • Investigational Site Number : 2030003
  • Ostrava, Czechia, 700 30
    • Investigational Site Number : 2030004
  • Pilsen, Czechia, 301 00
    • Investigational Site Number : 2030007
  • Prague, Czechia, 180 00
    • Investigational Site Number : 2030008
  • Prague, Czechia, 180 00
    • Investigational Site Number : 2030009
• Denmark
  • Hvidovre, Denmark, 2650
    • Investigational Site Number : 2080002
  • Odense, Denmark, 5000
    • Investigational Site Number : 2080003
• Finland
  • Espoo, Finland, 02230
    • Investigational Site Number : 2460006
  • Helsinki, Finland, 00100
    • Investigational Site Number : 2460001
  • Helsinki, Finland, 00290
    • Investigational Site Number : 2460008
  • Jarvenpaa, Finland, 04400
    • Investigational Site Number : 2460005
  • Oulu, Finland, 90220
    • Investigational Site Number : 2460004
  • Seinäjoki, Finland, 60100
    • Investigational Site Number : 2460002
  • Tampere, Finland, 33100
    • Investigational Site Number : 2460007
• Germany
  • Herxheim, Germany, 76863
    • Investigational Site Number : 2760008
  • Hürth, Germany, 50354
    • Investigational Site Number : 2760006
  • Hürth, Germany, 50354
    • Investigational Site Number : 2760007
  • Krefeld, Germany, 47799
    • Investigational Site Number : 2760005
  • Mönchengladbach, Germany, 41236
    • Investigational Site Number : 2760009
  • Schönau am Königssee, Germany, 83471
    • Investigational Site Number : 2760004
  • Wolfsburg, Germany, 38448
    • Investigational Site Number : 2760003
• Honduras
  • San Pedro Sula, Honduras
    • Investigational Site Number : 3400001
  • Tegucigalpa, Honduras, 11101
    • Investigational Site Number : 3400003
  • Tegucigalpa, Honduras, 11101
    • Investigational Site Number : 3400002
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-090
      • Investigational Site Number : 6160006
  • Lower Silesian Voivodeship
    • Trzebnica, Lower Silesian Voivodeship, Poland, 55-100
      • Investigational Site Number : 6160005
  • Lódzkie
    • Lodz, Lódzkie, Poland, 91-347
      • Investigational Site Number : 6160001
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-647
      • Investigational Site Number : 6160003
    • Warsaw, Masovian Voivodeship, Poland, 02-793
      • Investigational Site Number : 6160002
  • Silesian Voivodeship
    • Siemianowice Śląskie, Silesian Voivodeship, Poland, 41-103
      • Investigational Site Number : 6160004
• Spain
  • Madrid, Spain, 28041
    • Investigational Site Number : 7240009
  • Madrid, Spain, 28938
    • Investigational Site Number : 7240004
  • Sevilla
    • Seville, Sevilla, Spain, 41013
      • Investigational Site Number : 7240007
• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • Investigational Site Number : 8260004
  • England
    • London, England, United Kingdom, E1 1BB
      • Investigational Site Number : 8260007
    • London, England, United Kingdom, SW17 0QT
      • Investigational Site Number : 8260009
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Investigational Site Number : 8260010

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1: MenPenta vaccine formulation 1; MenPenta vaccine formulation 1, children 2-9 years of age	Biological: Pentavalent Meningococcal ABCYW vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM); Other Names: MenPenta
Experimental: Stage 1: MenPenta vaccine formulation 2; MenPenta vaccine formulation 2, children 2-9 years of age	Biological: Pentavalent Meningococcal ABCYW vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM); Other Names: MenPenta
Active Comparator: Stage 1: vaccine comparator(s); Comparator vaccines: Bexsero + MenQuadfi, children 2-9 years of age	Biological: MenACYW conjugate vaccine; Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM); Other Names: MenQuadfi®; Biological: MenACYW conjugate vaccine; Pharmaceutical form: Powder and solvent for injectable solution in a pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Nimenrix®; Biological: Meningococcal group B vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Bexsero®
Experimental: Stage 2: MenPenta vaccine formulation 1; MenPenta vaccine formulation 1 + routine vaccines, toddlers 12-15 months of age	Biological: Pentavalent Meningococcal ABCYW vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM); Other Names: MenPenta; 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); Other Names: Vaxelis®; Biological: DTap-HepB-IPV-Hib vaccine; Pharmaceutical form: Oral solution in tube Route of administration: oral; Other Names: Infanrix hexa®; Biological: Pneumococcal 13-valent conjugate vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Prevnar 13®
Experimental: Stage 2: MenPenta vaccine formulation 2; MenPenta vaccine formulation 2 + routine vaccines, toddlers 12-15 months of age	Biological: Pentavalent Meningococcal ABCYW vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM); Other Names: MenPenta; 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); Other Names: Vaxelis®; Biological: DTap-HepB-IPV-Hib vaccine; Pharmaceutical form: Oral solution in tube Route of administration: oral; Other Names: Infanrix hexa®; Biological: Pneumococcal 13-valent conjugate vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Prevnar 13®
Active Comparator: Stage 2: vaccine comparator(s); Comparator vaccines: Bexsero + MenQuadfi + routine vaccines, toddlers 12-15 months of age	Biological: MenACYW conjugate vaccine; Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM); Other Names: MenQuadfi®; Biological: MenACYW conjugate vaccine; Pharmaceutical form: Powder and solvent for injectable solution in a pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Nimenrix®; Biological: Meningococcal group B vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Bexsero®; 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); Other Names: Vaxelis®; Biological: DTap-HepB-IPV-Hib vaccine; Pharmaceutical form: Oral solution in tube Route of administration: oral; Other Names: Infanrix hexa®; Biological: Pneumococcal 13-valent conjugate vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Prevnar 13®
Experimental: Stage 3: MenPenta vaccine formulation 1; MenPenta vaccine formulation 1 + routine vaccines, infants approximately 2 months of age	Biological: Pentavalent Meningococcal ABCYW vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM); Other Names: MenPenta; 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); Other Names: Vaxelis®; Biological: DTap-HepB-IPV-Hib vaccine; Pharmaceutical form: Oral solution in tube Route of administration: oral; Other Names: Infanrix hexa®; Biological: Pneumococcal 13-valent conjugate vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Prevnar 13®; Biological: Rotavirus vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: RotaTeq® Rotarix®
Experimental: Stage 3: MenPenta vaccine formulation 2; MenPenta vaccine formulation 2 + routine vaccines, infants approximately 2 months of age	Biological: Pentavalent Meningococcal ABCYW vaccine; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM); Other Names: MenPenta; 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); Other Names: Vaxelis®; Biological: DTap-HepB-IPV-Hib vaccine; Pharmaceutical form: Oral solution in tube Route of administration: oral; Other Names: Infanrix hexa®; Biological: Pneumococcal 13-valent conjugate vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Prevnar 13®; Biological: Rotavirus vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: RotaTeq® Rotarix®
Active Comparator: Stage 3: vaccine comparator(s); Comparator vaccines: Bexsero + Nimenrix + routine vaccines, infants approximately 2 months of age	Biological: MenACYW conjugate vaccine; Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM); Other Names: MenQuadfi®; Biological: MenACYW conjugate vaccine; Pharmaceutical form: Powder and solvent for injectable solution in a pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Nimenrix®; Biological: Meningococcal group B vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Bexsero®; 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); Other Names: Vaxelis®; Biological: DTap-HepB-IPV-Hib vaccine; Pharmaceutical form: Oral solution in tube Route of administration: oral; Other Names: Infanrix hexa®; Biological: Pneumococcal 13-valent conjugate vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: Prevnar 13®; Biological: Rotavirus vaccine; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM); Other Names: RotaTeq® Rotarix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 immediate adverse events (AEs)	Unsolicited systemic AEs that occur within 30 minutes after vaccination	Within 30 minutes 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	hSBA titers ≥ 1:4 for additional MenB strains	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	hSBA titers ≥ 1:8 for additional MenB strains	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
Percentage of participants with hSBA composite seroresponse titers less than LLOQ 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

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• VAN00013 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Estimated): May 17, 2027
• Study Completion (Estimated): May 17, 2027

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Biological Products; Complex Mixtures; Vaccines; Viral Vaccines; Acetaminophen; 4CMenB vaccine; 13-valent pneumococcal vaccine; diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; Rotavirus Vaccines; DTaP-IPV-HB-PRP-T vaccine; Vaxelis
• Other Study ID Numbers: VAN00013 (Sanofi Identifier); 2023-510465-10 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes