Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine; Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine; Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed; GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant; Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine; Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed; GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
Intervention description: 0.5 milliliter (mL), Intramuscular (IM); 0.5 mL, IM; 0.5 mL, IM; 0.5 mL, IM; 0.5 mL, Intramuscular (IM); 0.5 mL, IM; 0.5 mL, IM
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1715.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Meningitis; MenACYW Conjugate vaccine; MENVEO vaccine; Adacel®; GARDASIL®

Summary:

      The purpose of the study was to evaluate the immunogenicity and describe the safety of
      Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate
      vaccine compared to the licensed vaccine MENVEO® in adolescents 10 to 17 years of age in the
      United States (US). This study also evaluated the immunogenicity and safety of MenACYW
      Conjugate vaccine when given alone compared to when given concomitantly with tetanus,
      diphtheria, acellular pertussis (Tdap) vaccine and human papilloma virus (HPV) vaccine.

      Primary objective:

        -  To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine
           when MenACYW Conjugate vaccine was given alone compared to those when MENVEO vaccine was
           given alone.

      Secondary objective:

        -  To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine,
           when MenACYW Conjugate vaccine was given concomitantly with Tdap and HPV vaccines,
           compared to those when it was given alone.

        -  To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap
           vaccine was given concomitantly with MenACYW Conjugate vaccine and HPV vaccine, compared
           to those when Tdap vaccine was given with HPV vaccine only.

        -  To evaluate the antibody responses to the antigens present in HPV vaccine after the
           3-dose series, when the first dose of HPV vaccine is given concomitantly with MenACYW
           Conjugate vaccine and Tdap vaccine, compared to those when the first dose of HPV vaccine
           is given with Tdap vaccine only.

      Observational objective:

        -  To describe the safety profile of MenACYW Conjugate vaccine, compared to that of the
           licensed vaccine MENVEO®, and when MenACYW Conjugate vaccine was given with Tdap and HPV
           vaccines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 10 to 17 years on the day of inclusion.

          -  Informed consent form was signed and dated by the parent(s) or another legally
             acceptable representative.

          -  Assent form was signed and dated by the participant.

          -  Participant and parent legally acceptable representative were able to attend all
             scheduled visits and comply with all trial procedures.

        Exclusion Criteria:

          -  Participant was 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 preceding the first trial vaccination(s) or
             planned receipt of any vaccine in the 4 weeks prior to or following any trial
             vaccination except for influenza vaccination, which may be received at least 2 weeks
             before or after any study vaccines. This exception included 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, W, or Y antigens.

          -  History of vaccination with any tetanus, diphtheria, or pertussis vaccine within the
             previous 4 years.

          -  Previous human papilloma virus (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., 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 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.

          -  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., human immunodeficiency virus [HIV] hepatitis B, hepatitis C)
             that, in the opinion of the investigator, was 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 degree fahrenheit [°F]). A
             prospective participant was not included in the study until the condition had resolved
             or the febrile event had 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., natural or adopted child) of the Investigator or employee with direct
             involvement in the proposed study.