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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 (MEQ00063)

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ClinicalTrials.gov Identifier: NCT03869866
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers (Meningococcal Infection) Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : December 25, 2021
Estimated Study Completion Date : December 25, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MenACYW conjugate vaccine
MenACYW conjugate single injection at Day 0
Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
Other Name: MenQuadfi®




Primary Outcome Measures :
  1. Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W [ Time Frame: Day 30 (post-vaccination) ]
    Percentage of participants with antibody titers greater than or equal to (≥) 1:8 against meningococcal serogroups A, C, Y, and W as measured by rSBA

  2. Antibody titers against meningococcal serogroups A, C, Y, and W (rSBA assessment) [ Time Frame: Day 30 (post-vaccination) ]
    Antibodies titers measured by rSBA and expressed as, but not limited to, Geometric Mean Titers (GMTs)

  3. Antibody titers against meningococcal serogroups A, C, Y, and W (hSBA assessment) [ Time Frame: Day 30 (post-vaccination) ]
    Antibodies titers measured by hSBA and expressed as, but not limited to, GMTs

  4. Antibody concentrations to tetanus toxoid [ Time Frame: Day 0 (pre-vaccination) and Day 30 (postvaccination) ]
    Geometric Mean Concentrations (GMCs) of antibodies against tetanus toxoid

  5. Number of participants achieving seroprotective levels [ Time Frame: Day 0 (pre-vaccination) and Day 30 (postvaccination) ]
    Seroprotective levels defined as antibody titers ≥ 0.01 International Units (IU) / milliliters (mL) of antibody concentrations to tetanus toxoid

  6. Number of participants reporting unsolicited systemic adverse events (AEs) [ Time Frame: Within 30 minutes post-vaccination ]
    Unsolicited systemic AEs reported in the 30 minutes after each vaccination

  7. Number of participants reporting solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days post-vaccination ]
    Solicited (prelisted in the subject's diary card and electronic case report book [CRB]) injection site and systemic reactions occurring up to 7 days after vaccination Injection site reactions: pain, erythema and swelling Systemic reactions: fever, headache, malaise, myalgia

  8. Number of participants reporting unsolicited non-serious AEs [ Time Frame: Within 30 days post-vaccination ]
    Unsolicited AEs (observed AE that does not fulfill the conditions prelisted in the CRB) includes both serious (SAEs) and non-serious unsolicited AEs

  9. Number of participants reporting serious adverse events (SAEs) [ Time Frame: Up to Day 30 (post-vaccination) ]
    SAEs (including adverse events of special interest [AESIs]) reported throughout the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   56 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869866


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
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Lebanon
Investigational site number 4220001 Recruiting
Beirut, Lebanon
Turkey
Investigational Site Number 7920002 Recruiting
Ankara, Turkey, 06590
Investigational Site Number 7920001 Recruiting
Ankara, Turkey, 06800
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03869866    
Other Study ID Numbers: MEQ00063
U1111-1183-6163 ( Other Identifier: UTN )
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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://www.clinicalstudydatarequest.com/

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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
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs