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OpenTrials
Completed

NCT Number: NCT03869866

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

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

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Key information

Conditions

Healthy Volunteers (Meningococcal Infection) Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

56 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number : 4220001, Beirut, Lebanon

Loading trial locations.

About this study

Study duration per participant is approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥ 56 years on the day of inclusion
  • 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)

Exclusion criteria

  • 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.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
  • 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.
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

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

Other names: MenQuadfi®

Primary outcomes

  1. 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

    Time frame: Day 30 post-dose

    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.

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

    Time frame: Day 30 post-dose

    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.

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

    Time frame: Day 30 post-dose

    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.

  4. Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid

    Time frame: Pre-dose Day 0 and Day 30 post-dose

    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.

  5. Percentage of Participants Who Achieved Seroprotective Levels

    Time frame: Pre-dose Day 0 and Day 30 post-dose

    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.

  6. Number of Participants With Unsolicited Systemic Adverse Events (AEs)

    Time frame: Within 30 minutes post-dose

    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].

  7. Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

    Time frame: Up to 7 days post-dose

    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.

  8. Number of Participants With Unsolicited Non-Serious Adverse Events

    Time frame: Up to Day 30 post-dose

    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).

  9. Number of Participants With Serious Adverse Events (SAEs)

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

    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.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older

Acronym: MEQ00063

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2019
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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