Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea

Sanofi

Status and phase

Completed

Phase 3

Conditions

Meningitis

Meningococcal Disease

Treatments

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01642589

U1111-1122-2028 (Other Identifier)

MTA52

Details and patient eligibility

About

The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in support of registration of the vaccine in South Korea.

Primary Objective:

To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y and W-135, 28 days after a single dose of Menactra®.

Secondary objectives:

To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine
To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine.
To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers before and 28 days after a single dose of Menactra® or Adacel® vaccine.

Full description

All participants will receive a single dose of vaccine, and will be assessed for immunogenicity at baseline (pre-vaccination) and at 28 days post-vaccination.

Safety data, including serious adverse events (SAEs) will be collected for Day 0 through Day 28 post-vaccination.

Enrollment

300 patients

Sex

All

Ages

11 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged 11 to 55 years on the day of inclusion
Subject aged 11 to 19 years: assent form signed and dated by the subject and informed consent form signed and dated by at least 1 parent or another legal representative
Subject aged 20 to 55 years: informed consent form signed and dated by the subject

If the subject or the subject's parent(s) or legal representative is illiterate, an independent witness is required to sign the consent form.

Subject and parent/legally acceptable representative (if applicable) are able to attend all scheduled visits and comply with all trial procedures
Covered by health insurance.

Exclusion criteria

Subject is pregnant, or lactating, or of child-bearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post menopausal for at least 1 year, surgically sterile (hysterectomy or bilateral tubal ligation), or using an effective method of contraception or abstinence for 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 a medical procedure
Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the trial vaccination. Monovalent pandemic influenza vaccines and multivalent pandemic influenza vaccines can be administered at any time during the study
Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine
Vaccination against diphtheria or tetanus in the past 5 years or any previous vaccination with either Adacel® or any other Tdap 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 invasive meningococcal disease, confirmed either clinically, serologically, or microbiologically
At high risk for invasive meningococcal disease during the trial
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
Thrombocytopenia, 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 at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
Received oral or injectable antibiotic therapy within the 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, 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
Personal history of Guillain-Barré Syndrome.