A Phase 3, Modified-double Blind, Multi-center Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers (2 to 23 Months of Age) in China

The purpose of this study is to describe the safety and immunogenicity of MenACYW conjugate vaccine compared with locally-licensed meningococcal vaccines in healthy infants and toddlers in China.
Study details include:
* Study duration (including 6-month safety follow-up after the last dose): - Cohort I (Groups 1 and 2): approximately 211 or 271 days (approximately 7 or 9 months) - Cohort II (Groups 3 and 4): up to 18 months - Cohort III (Groups 5 and 6): up to 21 months - Cohort III (Group 7): approximately 16 months
* Vaccination Visits Period:
* Cohort I (Groups 1 and 2): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91). Two blood samples are collected pre-vaccination (D01) and 30 days post the 2nd dose of vaccination (D61 or D121). Telephone calls (TCs) are planned on the 4th, the 9th, and the 21st day after each vaccination, and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit for safety follow-up. For participants receiving the second vaccination with a 3-month interval: an on-site visit is planned 30 days post the 1st dose of vaccination (V02, D31) for participant diary collection.
* Cohort II (Groups 3 and 4): a 2-dose vaccination at V01 (D01) and V02 (D31) or V03 (D91). A 1-dose booster is planned for Group 3 only at 18 MoA (within the 18th month from the participant's birth date). Up to 4 blood samples will be collected. In the primary vaccination period, blood samples are collected before the first primary vaccination (D01) and 30 days post the 2nd dose of primary vaccination (D61 or D121). A blood sample will be collected from all participants at 18 MoA. A post-booster blood sample will be collected from participants in Group 3, 30 days post their booster vaccination. Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods, respectively, for safety follow-up. For participants receiving the second vaccination with a 3-month interval: an on-site visit is planned 30 days post the 1st dose of vaccination (V02, D31) for participant diary collection. - Cohort III - Groups 5 and 6: a 3-dose primary vaccination at V01 (D01), V02 (D31) and V03 (D61), a 1-dose booster at 12 MoA (within the 12th months from the participant's birth date) on V05 or at 18 MoA (within the 18th months from the participant's birth date) on V06.
In total 4 blood samples are to be collected. In the primary vaccination period, blood samples are to be collected before the first primary vaccination (D01) and 30 days post the 3rd dose of primary vaccination (D91); in the booster vaccination period, blood samples are to be collected before booster vaccination at V05 (for participants receiving the booster at 12 MoA) or V06 (for participants receiving the booster at 18 MoA), and 30 days post booster vaccination (V05 + 30 days or V06 + 30 days). Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods respectively for safety follow-up.
- Cohort III - Group 7: a 3-dose primary vaccination at V01 (D01), V02 (D61) and V03 (D121), a 1-dose booster at V05 at 12 MoA (within the 12th months from the participant's birth date).
In total 4 blood samples are to be collected. In the primary vaccination period, blood samples are to be collected before the first primary vaccination (D01) and 30 days post the 3rd dose of primary vaccination (D151); in the booster vaccination period, blood samples are to be collected before booster vaccination at V05 and 30 days post booster vaccination (V06). Telephone calls are planned on the 4th, the 9th, and the 21st day after each vaccination (including the booster dose), and 5 TCs (1 TC/month) are planned for the 5 months post the last on-site visit of the primary and the booster vaccination periods (ie, V04 and V06), respectively, for safety follow-up. A safety visit is planned on the 9th day after the first vaccination for the ESDR participants (the first 30 participants in this group).

Start Date20 Aug 2026

Sponsor / Collaborator

Sanofi

NCT07621653

/ RecruitingNot Applicable

Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea

This surveillance is to investigate the safety profile of MenQuadfi®, when administered to participants aged 6 weeks to 55 years under the real-world clinical practice settings as per approved indications, including the Adverse Drug Reactions (ADRs)*.
*It includes ADRs that were not fully recognized in clinical practice, or unexpected ADRs which refer to those not listed in the approved drug labeling.

Start Date01 Jul 2026

Sponsor / Collaborator

Sanofi

NCT07135986

/ Active, not recruitingPhase 3

A Phase 3, Modified Double-blind, Multi-center Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents (2 to 17 Years of Age) in China

This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.
Study details include:
* The study duration will be approximately 180 days.
* The vaccination visit will be Visit 1.
* The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.

Start Date26 Sep 2025

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Meningococcal vaccine groups A C Y W-135 conjugate (second generation)(Sanofi)

100 Translational Medicine associated with Meningococcal vaccine groups A C Y W-135 conjugate (second generation)(Sanofi)

100 Patents (Medical) associated with Meningococcal vaccine groups A C Y W-135 conjugate (second generation)(Sanofi)

112

Literatures (Medical) associated with Meningococcal vaccine groups A C Y W-135 conjugate (second generation)(Sanofi)

31 Dec 2026·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of 4CMenB and MenACWY-CRM meningococcal vaccines when administered concomitantly in healthy adolescents: A phase 3b, randomized, observer-blind study

Article

Author: Lechevin, Isabelle ; Atwi, Jibran ; Keshavan, Pavitra ; Prato, Rosa ; Moraschini, Luca ; Possidente, Mariapia ; Hoberman, Alejandro ; Silas, Peter ; Lattanzi, Maria ; Bosis, Samantha ; Martin, Judith M. ; Manzella, Sara

Meningococcal vaccination of adolescents/young adults is recommended in various countries, including the United States (US). This phase 3b, observer-blind study (NCT04318548) evaluated the safety, reactogenicity, and immunogenicity of serogroup B vaccine, 4CMenB, and quadrivalent conjugate vaccine, MenACWY-CRM, when co-administered to healthy individuals aged 16-18 y, as per US Advisory Committee on Immunization Practices recommendations. Adolescents, who had received MenACWY vaccination ≥4 y previously, were randomized (N = 940; 1:1:1) to one of three groups to assess co-administration versus 4CMenB and MenACWY-CRM administered alone. Co-primary objectives were to demonstrate the non-inferiority of antibody responses after concomitant administration to antibody responses after 4CMenB (two doses administered 2 months apart) and MenACWY-CRM (single dose), as measured by human serum bactericidal assay (hSBA). Vaccine safety and reactogenicity were assessed as another primary objective. The co-primary endpoints were met: the lower limit of 2-sided 95% confidence intervals for all between-group ratios of hSBA geometric mean titers was >0.5 for the concomitant administration group versus 4CMenB group and MenACWY-CRM group. hSBA data after two 4CMenB doses and one MenACWY-CRM dose showed comparable between-group geometric mean ratios versus baseline, and percentages of participants with 4-fold rises in titers and titers ≥lower limit of quantitation. The safety profile of 4CMenB co-administered with MenACWY-CRM was comparable with that of 4CMenB administered alone. In conclusion, 4CMenB and MenACWY-CRM co-administration was well tolerated in adolescents aged 16-18 y and immune responses were comparable versus administration of each vaccine alone, which is consistent with a previous study of co-administration in infants.

31 Dec 2025·Human Vaccines & Immunotherapeutics

A new quadrivalent meningococcal tetanus toxoid conjugate vaccine: Menquadfi® (MENACWY-TT)

Review

Author: Tezer, Hasan ; Somer, Ayper ; Ciftci, Ergin ; Dinleyici, Ener Cagri ; Yilmaz, Dilek

Neisseria meningitidis (Nm) remains a major global health concern, causing invasive meningococcal disease (IMD) with significant morbidity and mortality. Despite vaccination efforts, Nm serogroup prevalence and antibiotic resistance continue to evolve, necessitating ongoing surveillance and novel immunization strategies. This review aims to assess the role of MenACWY-TT, a quadrivalent meningococcal conjugate vaccine, in IMD prevention by evaluating its immunogenicity, safety, and real-world effectiveness. The objectives include analyzing its advantages over existing vaccines, identifying gaps in long-term immunity data, and assessing its potential integration into National Immunization Programs (NIPs). MenACWY-TT has demonstrated strong immunogenicity, a favorable safety profile, and ease of administration with its liquid, non-adjuvanted formulation. Real-world studies show high vaccine effectiveness and herd protection benefits. However, further research is needed to evaluate long-term immunity and efficacy in high-risk populations.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of a 3-dose schedule of a quadrivalent meningococcal tetanus toxoid conjugate vaccine administered concomitantly with routine pediatric vaccines to infants and toddlers: A descriptive randomized study

Article

Author: Kharit, Susanna ; Singh Dhingra, Mandeep ; Syrkina, Olga ; Rehm, Christine ; Lyabis, Olga ; Zambrano, Betzana ; Villagomez-Martinez, Sandra ; Galustyan, Anna ; B’Chir, Siham

MenACYW-TT (MenQuadfi®), a quadrivalent meningococcal conjugate vaccine, is approved for use in individuals aged ≥12 months or ≥6 weeks depending on the country. This study reported the immunogenicity and safety of MenACYW-TT in individuals aged <12 months. This phase III, open-label, randomized, active-controlled study described the immunogenicity and safety of a 3-dose (2 + 1) immunization schedule of MenACYW-TT in Mexico and the Russian Federation or a 4-dose (3 + 1) immunization schedule of MCV4-CRM in Mexico, when co-administered with routine pediatric vaccines to healthy infants and toddlers aged 2 to 12 months (NCT03630705). The immunogenicity of meningococcal serogroups was assessed by serum bactericidal antibody assays using human complement. The safety data were collected for up to 30 d following vaccination. MenACYW-TT demonstrated high seroprotection rates in Mexico and in the Russian Federation after the last vaccination (booster) at 12 months of age. The proportion of participants achieving seroresponse to all 4 meningococcal serogroups after receiving 2 doses of MenACYW-TT in the infant series was comparable to the proportion of those receiving 3 doses of MCV4-CRM in Mexico. There was no clinically relevant effect on the immunogenicity and safety profile of the routine pediatric vaccines when administered concomitantly with MenACYW-TT at the same visit. No safety concern was observed during this study. MenACYW-TT demonstrated a safety profile generally comparable with that of MCV4-CRM when administered concomitantly with routine pediatric vaccines. The MenACYW-TT conjugate vaccine in a 2 + 1 schedule demonstrated an acceptable immunogenicity and safety profile.

News (Medical) associated with Meningococcal vaccine groups A C Y W-135 conjugate (second generation)(Sanofi)

04 Aug 2026

·www.pharmaindustrial-india.com

European Commission Expands Sanofi's MenQuadfi Approval to Include Infants from Six Weeks of Age

Sanofi has received approval from the European Commission (EC) to expand the indication of its MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age, providing earlier protection against Invasive Meningococcal Disease (IMD) caused by Neisseria meningitidis serogroups A, C, W and Y. The approval extends MenQuadfi's previous European Union indication, which covered individuals aged 12 months and older, and follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in June 2026. The expanded indication is expected to strengthen routine infant immunisation programmes across Europe, offering healthcare providers an additional vaccination option for one of the populations most vulnerable to invasive meningococcal disease. IMD is a rapidly progressing bacterial infection that can become fatal within 24 hours of symptom onset. Infants face the highest risk of severe disease, with complications including limb amputation, hearing loss and permanent neurological damage. Despite appropriate medical treatment, the disease carries a mortality rate of approximately 10–15 percent, while up to one in five survivors experiences long-term health complications. Although meningococcal serogroup A is now uncommon across the European Union, serogroups C, W and Y continue to account for a significant proportion of reported cases, highlighting the importance of broad protection during early infancy. Federico Martinon-Torres, paediatrician, clinical researcher and Principal Investigator of the MET58 study, said broad age indications are essential for meeting public health needs. He noted that MenQuadfi's robust immunogenicity data in infants supports its integration into routine vaccination schedules while helping improve vaccine coverage across the region. The EC approval is supported by data from the pivotal MET58 clinical trial, which evaluated the vaccine's immunogenicity, safety and tolerability in infants beginning at six weeks of age. The evidence demonstrated strong immune responses and a safety profile comparable to other licensed quadrivalent meningococcal conjugate vaccines. Bogdana Coudsy, Global Head of Medical, Vaccines at Sanofi, said the approval reinforces the company's commitment to protecting the youngest and most vulnerable populations by providing healthcare professionals with an additional option to help prevent invasive meningococcal disease from the earliest weeks of life. Under the updated label, infants starting vaccination from six weeks of age will receive a 2 plus 1 dosing schedule, consisting of two primary doses administered at least two months apart, followed by a booster dose in the second year of life. For infants at increased risk of exposure to serogroup A, a 3+1 schedule may also be used. Individuals aged 12 months and older will continue to receive a single-dose regimen. MenQuadfi can also be administered alongside routine childhood vaccines, including diphtheria, tetanus, acellular pertussis, inactivated poliovirus, hepatitis B, Haemophilus influenzae type b, rotavirus and pneumococcal conjugate vaccines, facilitating its incorporation into existing immunisation programmes. Sanofi noted that more than 6,000 infants across 11 countries have participated in MenQuadfi clinical studies, generating extensive evidence supporting the vaccine's safety and effectiveness. The vaccine is currently approved in the European Union, the United States and several other countries, and the latest approval completes all paediatric post-authorisation commitments outlined under the European Medicines Agency's Paediatric Investigation Plan.

Drug ApprovalVaccineClinical Result

04 Aug 2026

·www.biospace.com

Press Release: Sanofi’s MenQuadfi approved in the EU for use in infants from age six weeks against invasive meningococcal disease

Sanofi’s MenQuadfi approved in the EU for use in infants from age six weeks against invasive meningococcal disease Paris, August 4, 2026. Sanofi today announced that the European Commission (EC) has approved an extension of the indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age to help protect against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi was previously approved in the EU for use in individuals aged 12 months and older. The expanded indication follows the positive opinion adopted by the Committee for Medicinal Products for Human Use on June 25, 2026. Invasive meningococcal disease is a life-threatening bacterial infection that can progress rapidly, with patients potentially deteriorating from the onset of symptoms to death within 24 hours. Infants are among the populations at highest risk for invasive meningococcal disease, facing high rates of mortality and severe long-term complications, including limb amputation, hearing loss, and neurological damage. Even with appropriate treatment, invasive meningococcal disease carries a case fatality rate of approximately 10–15%, and up to 20% of survivors experience permanent complications. Although serogroup A is now rarely reported in the EU, serogroups C, W, and Y remain responsible for a significant share of invasive meningococcal disease cases across Europe, reinforcing the importance for broad protection against these four serogroups from an early age. " Meningococcal disease moves fast and strikes the hardest in younger children. Having a product indicated across a broad age range is key to meeting public health needs — giving healthcare providers the flexibility to help protect infants within routine immunization schedules and increase vaccine coverage. The immunogenicity data for MenQuadfi in infants is robust and supports the usage with confidence in the EU , " said Federico Martinon-Torres , Pediatrician and Clinical Researcher, Head of Pediatrics and Vaccine Research Unit at Hospital Clínico Universitario de Santiago in Spain and Principal Investigator of MET58. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); With this approval, MenQuadfi provides healthcare professionals in the EU with an additional option for vaccinating infants against invasive meningococcal disease from as early as six weeks of age. This expanded indication, aligned with routine infant immunization schedules, is supported by MenQuadfi's demonstrated immunogenicity data. "Offering protection for the EU's youngest children is at the heart of what we do — and this approval is a direct expression of that commitment. It reflects the scientific rigor behind this work, and it means healthcare providers now have an additional option to help protect infants against invasive meningococcal disease from the early weeks of life," said Bogdana Coudsy , Global Head of Medical, Vaccines, Sanofi. This milestone embodies Sanofi's contribution, fighting against invasive meningococcal disease, a devastating disease, by expanding vaccine access to the most vulnerable populations across the EU. About the MET58 pivotal study The EU approval is supported by comprehensive data from the MET58 pivotal clinical study, which evaluated the immunogenicity, safety, and tolerability of MenQuadfi in infants from six weeks of age. About MenQuadfi MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) is indicated for active immunization of individuals six weeks of age and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi benefits from a strong track record of clinical data in infants with more than 6,000 infants studied across 11 countries and multiple immunization schedules. The new dose regimen approved for those starting vaccination from six weeks of age is aligned with routine pediatric vaccination schedules. The approved dosing regimens include: 2+1 schedule for infants from six weeks of age, aligned with standard EU immunization schedules. Two doses (each 0.5mL) should be administered with an interval of at least two months. One dose (booster) should be given in the second year of life (from 12 months of age) and at least two months from the last dose. For infants expected to be at increased risk of invasive meningococcal disease due to serogroup A exposure, a 3+1 schedule may be considered. Three doses primary series at two, four and six months followed by one booster dose from 12 months of age. Single dose for individuals 12 months of age and older. In infants, MenQuadfi can be co-administered with combined diphtheria - tetanus - acellular pertussis (DTaP) - inactivated poliovirus (IPV) - hepatitis B (HepB) - Haemophilus influenzae type b (Hib) vaccine (DTaP-IPV-HepB-Hib), rotavirus vaccine (live attenuated) and with 10-valent pneumococcal conjugate vaccine (PCV10). The safety and immunogenicity pro been established across a broad age range, from six weeks of age through adulthood. MenQuadfi is well tolerated, with a safety pro to other MenACWY vaccines currently licensed. The Paediatric Investigation Plan compliance statement has been received from the European Medicines Agency, marking the completion of all pediatric post-licensure commitments linked to MenQuadfi's initial marketing authorization. MenQuadfi is approved in the EU, US, and multiple other countries. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com Ekaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.com Laura Romby | +33 6 74 16 74 29 | laura.romby@sanofi.com Investor Relations Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com Sanofi forward-looking statements This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” "attempt," “target,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,” “guideline,” "seek," “should,” “will,” "goal," or the negative of these and similar expressions are intended to identify forward-looking statements. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks, uncertainties and assumptions include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues; competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025, or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein. All trademarks mentioned in this press release are the property of the Sanofi group. Attachment Press Release

03 Aug 2026

·www.pharmaindustrial-india.com

EU Approves Sanofi's MenQuadfi for Invasive Meningococcal Disease

Sanofi announced that the European Commission (EC) has approved an extension of the indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from 6 weeks of age to help protect against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi was previously approved in the EU for use in individuals aged 12 months and older. The expanded indication follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) on June 25, 2026. Invasive meningococcal disease is a life-threatening bacterial infection that can progress rapidly, with patients potentially deteriorating from the onset of symptoms to death within 24 hours. Infants are among the populations at highest risk for invasive meningococcal disease, facing high rates of mortality and severe long-term complications, including limb amputation, hearing loss, and neurological damage. Even with appropriate treatment, invasive meningococcal disease carries a case fatality rate of approximately 10-15 percent, and up to 20 percent of survivors experience permanent complications. Although serogroup A is now rarely reported in the EU, serogroups C, W, and Y remain responsible for a significant share of invasive meningococcal disease cases across Europe, reinforcing the importance for broad protection against these 4 serogroups from an early age. Federico Martinon-Torres, Pediatrician and Clinical Researcher, Head of Pediatrics and Vaccine Research Unit, Hospital Clínico Universitario de Santiago in Spain and Principal Investigator of MET58, said, "Meningococcal disease moves fast and strikes the hardest in younger children. Having a product indicated across a broad age range is key to meeting public health needs—giving healthcare providers the flexibility to help protect infants within routine immunisation schedules and increase vaccine coverage. The immunogenicity data for MenQuadfi in infants is robust and supports the usage with confidence in the EU.” With this approval, MenQuadfi provides healthcare professionals in the EU with an additional option for vaccinating infants against invasive meningococcal disease from as early as 6 weeks of age. This expanded indication, aligned with routine infant immunisation schedules, is supported by MenQuadfi's demonstrated immunogenicity data. Bogdana Coudsy, Global Head of Medical, Vaccines, Sanofi, said, "Offering protection for the EU's youngest children is at the heart of what we do—and this approval is a direct expression of that commitment. It reflects the scientific rigor behind this work, and it means healthcare providers now have an additional option to help protect infants against invasive meningococcal disease from the early weeks of life." This milestone embodies Sanofi's contribution, fighting against invasive meningococcal disease, a devastating disease, by expanding vaccine access to the most vulnerable populations across the EU.

Drug ApprovalVaccine

100 Deals associated with Meningococcal vaccine groups A C Y W-135 conjugate (second generation)(Sanofi)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07AH08	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Meningococcal Infections	Canada	Sanofi Pasteur, Inc.	29 Oct 2020
Invasive meningococcal disease	United States	Sanofi Pasteur, Inc.	23 Apr 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Meningitis, Meningococcal	NDA/BLA	European Union	Sanofi Winthrop Industrie SA	-
Meningitis	Phase 2	United States	Sanofi Pasteur SA	16 Dec 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05929651 (CTgov)	Phase 4	Meningococcal Infections	71	MenACYW conjugate vaccine	frdvrpbjob = aynfquxjdb svbqadkile (hmfwozdusv, agbtlifkce - labvznompz) View more	-	22 Sep 2025
NCT06228586 (CTgov)	Phase 3	Meningococcal Infections	447	MenACYW Conjugate Vaccine (MenACYW Conjugate Vaccine: 12-23 Months of Age)	upnupckbdh(biysmswonx) = ziqkjyqlyk bgijizakpf (wwlbdutitw, oabpgelhsr - xychylqkke) View more	-	17 Sep 2025
				MenACYW Conjugate Vaccine (MenACYW Conjugate Vaccine: 24 Months of Age and Above)	upnupckbdh(biysmswonx) = lfcbibxvws bgijizakpf (wwlbdutitw, gbcutfmczr - svmbkyjudq) View more
NCT03869866 (MEQ00063, CTgov)	Phase 3	Meningococcal Infections	290	Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine	ynkxidxwbr = tlyecguvpo aaaiupxsej (elqmirtufg, kjbbemndfq - pdxmiahghn) View more	-	17 Mar 2025
NCT04143061 (MET55, CTgov)	Phase 3	Meningococcal Infections	1,328	MenACYW Conjugate Vaccine (Group 5 + Group 7: MenACYW Conjugate Vaccine)	maancxtxqh = umunbjepgk ghlpfnpcsa (cjbqzjptte, gzbdebyzvt - uwusrxtubs) View more	-	03 Feb 2025
				Menactra (Group 6 + Group 8: Menactra®)	maancxtxqh = soukyqhqfy ghlpfnpcsa (cjbqzjptte, riddcsaurp - ihmctjxoox) View more
NCT03547271 (CTgov)	Phase 3	Meningococcal Infections	1,660	Pneumococcal vaccine (10-valent)+MenACYW conjugate vaccine+DTaP-IPV-HB-Hib vaccine+MMR vaccine (Group 1: MenACYW)	pubxamflbc(dnazvicemu) = xkmwlukkxi sgcnwbcmie (zsdcozwbaq, idflsyuauk - vcxtwattjl) View more	-	22 Jan 2025
				Pneumococcal vaccine (10-valent)+DTaP-IPV-HB-Hib vaccine+Meningococcal group A, C, W-135, and Y conjugate vaccine+MMR vaccine (Group 2: Nimenrix)	pubxamflbc(dnazvicemu) = qdddconixb sgcnwbcmie (zsdcozwbaq, fhmixmhveh - jofgvyfnhl) View more
NCT03537508 (CTgov)	Phase 3	Meningococcal Infections	2,627	MenACYW Conjugate Vaccine (Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination))	ydkepksxle = jkdzaywtqn dsqnxiurwp (hpssunduzq, rbppydfbzv - tjjoohjyja) View more	-	15 Oct 2024
				MENVEO (Group 2a: MENVEO (Post 12-month Vaccination))	ydkepksxle = urjgucexie dsqnxiurwp (hpssunduzq, iniqaphbtg - zosrdnrwrv) View more
NCT03691610 (CTgov)	Phase 3	Meningococcal Infections	950	MenACYW conjugate vaccine (Infants: Group 1)	hhpkxgvzbe = xdpqifmbqq nzwcexutzb (fmhtmxtdci, gdfavhzxmh - bblawerplp) View more	-	25 Jun 2024
				MENVEO (Infants: Group 2)	hhpkxgvzbe = wweuhjhrph nzwcexutzb (fmhtmxtdci, iloahftitu - koaoxiicxm) View more
NCT03632720 (CTgov)	Phase 3	Meningococcal Infections	788	Meningococcal group B vaccine+Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine+Human rotavirus RIX4414 strain vaccine+Pneumococcal 13-valent polysaccharide conjugate vaccine (Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months))	miznponpfg = agcswrnawv vgdcjbfjqg (qdvagjwdha, cjlpenvsdy - pnxnsvrmdr) View more	-	07 Nov 2023
				Meningococcal group B vaccine+Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine+Human rotavirus RIX4414 strain vaccine+Pneumococcal 13-valent polysaccharide conjugate vaccine (Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months))	miznponpfg = qseniabaew vgdcjbfjqg (qdvagjwdha, nbtvyjfvbp - tbgzcdwudz) View more
NCT03630705 (MET33, CTgov)	Phase 3	Meningococcal Infections	525	Meningococcal Polysaccharide (Serogroups A, C, Y, and W)+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine+Pneumococcal 13-valent Conjugate Vaccine+Rotavirus Vaccine, Live, Pentavalent (Group 1: MenACYW Conjugate Vaccine (Mexico))	ssmqqmrgrw = cyvsqamcop mgptyflsxd (hrjtepccih, vsboxhdrli - koxdoibvxz) View more	-	19 Oct 2023
				Meningococcal Polysaccharide (Serogroups A, C, Y, and W)+Measles, Mumps, and Rubella Virus Vaccine Live+Hepatitis B Vaccine+Haemophilus influenza type b Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 3: MenACYW Conjugate Vaccine (Russian Federation))	ncspvjljnt = rcvmieensg pypehvlhek (bdbhbghsgw, edpyewhneh - vreucanbav) View more
NCT03673462 (MET41, CTgov)	Phase 3	Meningococcal Infections	2,797	Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)+Hepatitis B Vaccine+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine+Varicella Virus Vaccine+Rotavirus Vaccine+Pneumococcal 13-valent Conjugate Vaccine+Measles, Mumps, and Rubella Virus Vaccine (Group 1: MenACYW Conjugate Vaccine)	spjnewgykg = rmqfkfnsix vpiidocdhg (hrfbexrfgy, bxddafekro - dvafiqmoeh) View more	-	05 Oct 2023
				Hepatitis B Vaccine+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine+Varicella Virus Vaccine+Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)+Rotavirus Vaccine+Pneumococcal 13-valent Conjugate Vaccine+Measles, Mumps, and Rubella Virus Vaccine (Group 2: MENVEO®)	spjnewgykg = tdzvuyygxj vpiidocdhg (hrfbexrfgy, hyxyuonggs - bjknnqfxle) View more

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