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

Conditions: To prevent Meningococcal meningitis and sepsis caused by Neisseria meningitidis.
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2015-005181-33-Outside-EU/EEA

Lead Sponsor: Sanofi Pasteur SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 300

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 149
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 151
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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® (Group 1) ;Secondary Objective: - 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.<br> - To describe the SBA BR titers before and 28 days after a single dose of Menactra® or Adacel® vaccine.<br> - To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine.;Primary end point(s): - Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine.<br>;Timepoint(s) of evaluation of this end point: - 28 Days post-vaccination.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Percentage of Participants With Functional Antibody Titers at =1:8 Dilution Before and After Menactra® or Adacel® Vaccination.<br> - Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination.<br> - Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine.;Timepoint(s) of evaluation of this end point: - Day 0 (pre-vaccination) and 28 days post-vaccination.<br>- Day 0 (pre-vaccination) and 28 days post-vaccination.<br> - Day 0 up to Day 28 post-vaccination