Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

Completed · Phase 3

Conditions studied: Meningitis, Meningococcal Meningitis, Meningococcal Infections

In brief

The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received their first quadrivalent meningococcal Conjugate vaccine dose in the past 4-10 years. Primary Objective: * To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW Conjugate vaccine compared to those observed following the administration of a booster dose of Menactra® in participants who were first vaccinated with 1 dose of a quadrivalent meningococcal vaccine 4 to 10 years before the booster dose. Secondary Objectives: * To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after vaccination in a subset of 120 participants. * To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination. Observational Objectives: * To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination. * To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days after vaccination with MenACYW Conjugate vaccine or Menactra® measured by rabbit serum bactericidal assay (rSBA) in a subset of participants. * To describe the safety profile of MenACYW Conjugate vaccine compared to that of a licensed Menactra® after booster vaccination.

Key facts

Study ID

NCT02752906

Run by

Sanofi Pasteur, a Sanofi Company

People needed

810

Starts

2016-04-15

Expected to finish

2016-12-19

Last updated by the study team

2022-04-05

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged >= 15 years on the day of inclusion.
• Participant has documented record of having received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years prior to study vaccination.
• Participant aged 15 to < 18 years: assent form signed and dated by the participant and informed consent form (ICF) signed and dated by the parent or guardian.
• Participant aged >=18 years: ICF signed and dated by the participant.
• Participants aged 15 to < 18 years: both the participant and parent / guardian were able to attend all scheduled visits and to comply with all trial procedures.
• Participants aged >= 18 years: able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if…

• Participant was pregnant, lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).
• 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 before Day 30 visit except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Previous vaccination against meningococcal disease with either an investigational or approved meningococcal B vaccine.
• 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, or participants travelling to countries with high endemic or epidemic disease).
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
• Personal history of Guillain-Barré syndrome.
• Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator's opinion.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 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 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 the Investigator's judgment) on the day of vaccination or febrile illness (temperature >= 100.4°Fahrenheit [F]). 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.

Where it is running

• Investigational Site Number 016 — Birmingham, Alabama, United States
• Investigational Site Number 032 — Dothan, Alabama, United States
• Investigational Site Number 026 — Mesa, Arizona, United States
• Investigational Site Number 022 — Jonesboro, Arkansas, United States
• Investigational Site Number 005 — Downey, California, United States
• Investigational Site Number 014 — La Puente, California, United States
• Investigational Site Number 029 — San Diego, California, United States
• Investigational Site Number 001 — San Diego, California, United States
• Investigational Site Number 013 — Bardstown, Kentucky, United States
• Investigational Site Number 027 — Nicholasville, Kentucky, United States
• Investigational Site Number 015 — Metairie, Louisiana, United States
• Investigational Site Number 018 — Woburn, Massachusetts, United States
• Investigational Site Number 010 — Troy, Michigan, United States
• Investigational Site Number 008 — Kansas City, Missouri, United States
• Investigational Site Number 028 — St Louis, Missouri, United States
• Investigational Site Number 023 — Lincoln, Nebraska, United States
• Investigational Site Number 031 — Omaha, Nebraska, United States
• Investigational Site Number 006 — Rochester, New York, United States
• Investigational Site Number 012 — Fargo, North Dakota, United States
• Investigational Site Number 019 — Cincinnati, Ohio, United States
• Investigational Site Number 011 — Fairfield, Ohio, United States
• Investigational Site Number 025 — Huber Heights, Ohio, United States
• Investigational Site Number 021 — Kettering, Ohio, United States
• Investigational Site Number 009 — Erie, Pennsylvania, United States
• Investigational Site Number 007 — Hermitage, Pennsylvania, United States

Full record on ClinicalTrials.gov

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