Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon

NCT03869866 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MEQ00063U1111-1183-6163
• Study Type: interventional
• Target: 290
• Locations: 2 countries
• Sites: 3

Brief Summary

The primary objectives of this study are:

• To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of MenACYW conjugate vaccine
• To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using human complement (hSBA) before and after a single dose of MenACYW conjugate vaccine
• To describe the antibody responses against tetanus toxoid at baseline and after a single dose of MenACYW conjugate vaccine
• To describe the safety profile of a single dose of MenACYW conjugate vaccine

Conditions

Healthy Volunteers (Meningococcal Infection)

Outcome Measures

Primary Outcomes (9)

• Percentage of Participants With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, W, and Y

  Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA. Seroprotection rate is defined as percentage of participants with rSBA titer \>=1.8 who received MenACYW conjugate vaccine. Percentages are rounded off to the tenth decimal place.

  Day 30 post-dose

• Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA

  Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers.

  Day 30 post-dose

• Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA)

  Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.

  Day 30 post-dose

• Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid

  Tetanus toxoid was contained in the investigational vaccine as a carrier protein. Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.

  Pre-dose Day 0 and Day 30 post-dose

• Percentage of Participants Who Achieved Seroprotective Levels

  Seroprotective levels defined as antibody titers \>= 0.01 IU/mL and \>= 0.1 IU/mL of antibody concentrations to tetanus toxoid. Tetanus toxoid was contained in the investigational vaccine as a carrier protein. Anti-tetanus antibodies were measured by ECL assay. The captured antibodies were then detected using a sulfotag-conjugated anti-human IgG conjugate. Percentages are rounded off to the tenth decimal place.

  Pre-dose Day 0 and Day 30 post-dose

• Number of Participants With Unsolicited Systemic Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions \[i.e.pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination\].

  Within 30 minutes post-dose

• Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

  All noxious and unintended responses to a study vaccine related to any dose was considered adverse reactions (AR). A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection site reaction is an AR at and around the injection site. Injection site reactions are commonly inflammatory reactions. They were considered to be related to the study vaccine administered. Systemic reactions were all ARs that were not injection or administration site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination or administration site.

  Up to 7 days post-dose

• Number of Participants With Unsolicited Non-Serious Adverse Events

  An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e. pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination).

  Up to Day 30 post-dose

• Number of Participants With Serious Adverse Events (SAEs)

  A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other important medical event.

  From Day 0 up to end of study, approximately 44 days

Study Arms (1)

MenACYW conjugate vaccine

EXPERIMENTAL

MenACYW conjugate single injection at Day 0

Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine

Interventions

Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine BIOLOGICAL

Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Also known as: MenQuadfi®

MenACYW conjugate vaccine

Eligibility Criteria

• Age: 56 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent form has been signed and dated
• Able to attend all scheduled visits and to comply with all trial procedures
• Intending to go on a Hajj or Umrah pilgrimage (but not within the next 10 to 12 months after vaccination)

You may not qualify if:

• Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile).
• Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Any previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y).
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• 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 long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
• At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia).
• Known systemic hypersensitivity to any of the vaccine components, or history of a lifethreatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances .
• Personal history of Guillain-Barre syndrome (GBS).
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination.
• Verbal report thrombocytopenia, contraindicating intramuscular vaccination, in the Investigator's opinion.
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Current alcohol abuse or drug addiction.
• Chronic illness (eg, human immunodeficiency virus \[HIV\], hepatitis B, hepatitis C) that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Investigational Site Number : 4220001

Beirut, 11-0236, Lebanon

Location

Investigational Site Number : 7920002

Ankara, 06590, Turkey (Türkiye)

Location

Investigational Site Number : 7920001

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (1)

• Dbaibo GS, Balik I, Akdemir I, Buzgan T, Guner R, Boutros CF, Damaj S, Zein ZE, Merhi S, Faour K, Tfaily N, Khafaja S, Dogu A, Ceyhan M. Immunogenicity and Safety of Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Potential Hajj/Umrah Pilgrims Aged >/= 56 Years: A Phase III, Open-Label Study. Infect Dis Ther. 2026 Jan 28. doi: 10.1007/s40121-025-01298-w. Online ahead of print.

  PMID: 41604139 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 11, 2019
• Study Start: April 9, 2019
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

LE (1); TU (2)