A Phase 1/2 interventional study of Pentavalent Meningococcal ABCYW vaccine and MenACYW conjugate vaccine in Meningococcal Immunization and Healthy Volunteers, sponsored by Sanofi Pasteur, a Sanofi Company. Active, not recruiting at 39 sites in 9 countries. Open to participants aged 56 Days to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 1/2, Interventional, and Prevention
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.
Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MenPenta vaccine formulation 1, children 2-9 years of age
Biological: Pentavalent Meningococcal ABCYW vaccine
MenPenta vaccine formulation 2, children 2-9 years of age
Biological: Pentavalent Meningococcal ABCYW vaccine
Comparator vaccines: Bexsero + MenQuadfi, children 2-9 years of age
Biological: MenACYW conjugate vaccine · Biological: Meningococcal group B vaccine
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
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
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
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
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
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
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
Also known as: MenPenta
Pharmaceutical form: Solution for injection in vial Route of administration: Intramuscular (IM)
Also known as: MenQuadfi®
Pharmaceutical form: Powder and solvent for injectable solution in a pre-filled syringe Route of administration: Intramuscular (IM)
Also known as: Nimenrix®
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Also known as: Bexsero®
Pharmaceutical form:Suspension-Route of administration:oral
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Also known as: Hexyon®
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Also known as: Vaxelis®
Pharmaceutical form: Oral solution in tube Route of administration: oral
Also known as: Infanrix hexa®
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Also known as: RotaTeq® Rotarix®
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular (IM)
Also known as: Prevnar 13®
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: For Stage 1 and 2: Day 1, Day 31, Day 181, Day 211
hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse in children, toddler and infant participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Stage 1 and 2: Day 1 and Day 211. Stage 3: Day 1, Day 331-391
Plan to share: Yes — 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
Started Nov 2024 (actual). Primary completion is estimated for May 2027, 30 months after the start.
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This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acetaminophen · DTaP-IPV-HB-PRP-T vaccine · Vaxelis · Diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine · 13-valent pneumococcal vaccine
Sanofi Pasteur, a Sanofi Company →