Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents

Phase 1

• Conditions: Healthy volunteers (active immunization against invasive meningococcal disease (IMD) caused by Meningococcal serogroups A, C, Y or W; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-001963-35-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-06
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1715

Inclusion Criteria

- Aged 10 to 17 years on the day of inclusion
- Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative
- Assent form has been signed and dated by the subject
- Subject and parent legally acceptable representative are able to attend all scheduled visits and comply with all trial procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1715
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
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 childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
- Participation in the 4 weeks preceding the first trial vaccination(s) 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 first trial vaccination(s) 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 any study vaccines. This exception includes monovalent influenza vaccines and multivalent influenza vaccines.
- Previous vaccination against meningococcal disease with either the trial vaccine or any mono- or polyvalent polysaccharide or conjugate meningococcal vaccine containing A, C, Y, or W antigens.
- History of vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 4 years.
- Previous HPV vaccination
- 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 (i.e., subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects 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 vaccines used in the trial or to a vaccine containing any of the same substances, including encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine
- Personal history of Guillain-Barré 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 of 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 (e.g., 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 = 100.4°F). 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 72 hours prior to the first blood

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: -To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine, when MenACYW conjugate vaccine is given concomitantly with Tdap and HPV vaccines, compared to those when it is given alone.<br>-To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap vaccine is given concomitantly with MenACYW conjugate vaccine and HPV vaccine, compared to those when Tdap vaccine is given with HPV vaccine only.;Main Objective: To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine when MenACYW conjugate vaccine is given alone compared to those when MENVEO vaccine is given alone.;Primary end point(s): Antibody titers against meningococcal serogroups A, C, Y, and W135 measured by serum bactericidal assay using human complement (hSBA) for the subjects receiving either MenACYW conjugate vaccine or MenACYW conjugate vaccine, Tdap and HPV;Timepoint(s) of evaluation of this end point: Day 0 and Day 30 post-vaccination