Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older



Status:Completed
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:56 - Any
Updated:2/11/2018
Start Date:November 2012
End Date:September 2013

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Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older

Primary objectives:

- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135,
measured by serum bactericidal assay using human complement (hSBA) and baby rabbit
complement (SBA-BR), induced by a single dose of MenACYW conjugate vaccine or Menomune®
- A/C/Y/W-135.

- To describe the safety profile of a single dose of MenACYW conjugate vaccine or
Menomune® - A/C/Y/W-135.

All participants will receive a single dose of their assigned vaccine on Day 0. They will be
assessed for immunogenicity on Day 30, and monitored for safety throughout the study.

Inclusion Criteria:

- Aged 56 or older 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. Exclusion
Criteria:

- Subject is pregnant, or lactating, or of childbearing potential (to be considered of
non-childbearing potential, a female must be 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 and until at least 4 weeks after vaccination)

- Participation at the time of study enrollment (or 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 preceding the trial vaccination or planned
receipt of any vaccine in the 4 weeks following the trial vaccination except for
influenza vaccination, which may be received at least 2 weeks before or after the
study vaccines

- Previous vaccination against meningococcal disease with either a trial vaccine or
another 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

- Known systemic hypersensitivity to latex or any of the vaccine components, or history
of a severe reaction to the vaccines used in the trial or to a vaccine containing any
of the same substances

- Personal history of Guillain-Barré syndrome

- 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

- Self-reported thrombocytopenia, contraindicating intramuscular vaccination

- 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 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 ≥ 100.4°F [≥ 38.0°C]). A
prospective subject 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 3 days prior to any blood
draw. Should a subject receive oral or injectable antibiotic therapy within 3 days
prior to any blood draw, the Investigator will postpone the blood draw until it has
been 3 days since the subject last received oral or injectable antibiotic therapy.
Postponement must still be within the timeframe for blood draw indicated in the Table
of Study Procedures, when possible

- 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.
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