Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents
Condition: Meningococcal Immunisation; Healthy Volunteers
Intervention: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine); Meningococcal group A, C, W-135, and Y conjugate vaccine; Human Papillomavirus 9-valent Vaccine (9vHPV); Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)
Intervention description: Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular; Pharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a parallel group prevention study with 2 groups that were observer blind (only the person administering the vaccine was unblinded), and 1 group that was open-label.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The study was performed in a partially observer-blind fashion:
In Groups 1 and 2
Investigators and study staff who conducted the safety assessment, participants, parents/legally acceptable representatives, the Sponsor, and laboratory personnel performing the serology testing were kept blinded to the vaccine received.
Only the study staff who prepared and administered the vaccine and were not involved with the safety evaluation know which vaccine was administered.
In Group 3
- Everyone involved in the study (i.e., Investigator, study staff, the Sponsor, participants, parents/legally acceptable representatives) know which vaccine was administered. This open-label design for Group 3 was due to the different vaccination schedule for this group than for Groups 1 and 2.
Enrollment: 463.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary Objective:

      To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using
      human complement [hSBA] titer greater than or equal to [>=] 1:8) to meningococcal serogroups
      A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide
      (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine)
      (Group 1) compared to a single dose of Nimenrix® (Group 2).

      Secondary Objective:

      To describe:

        -  the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA,
           before and 1 month following meningococcal vaccination administered alone (Groups 1 and
           2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria,
           and acellular pertussis - inactivated polio vaccine [adsorbed, reduced antigen(s)
           content] (Tdap-IPV) vaccines (Group 3).

        -  the antibody response of meningococcal serogroup C measured by hSBA and serum
           bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31
           after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according
           to MenC primed status.

        -  the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1
           month following vaccination.

        -  the safety profile in each group after each and any vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 10 to 17 years on the day of inclusion ('10 to 17 years' means from the day of
             the 10th birthday to the day before the 18th birthday).

          -  Meningococcal serogroup C Conjugate vaccine (MenC) naïve participants or participants
             having received monovalent MenC priming in infancy (less than [<] 2 years of age).

          -  Assent form had been signed and dated by the participant as per local regulation, and
             Informed Consent Form had been signed and dated by the parent/legally acceptable
             representative and by the participant if she/he turns 18 years old during the study.

          -  Participants and parent/legally acceptable representative were able to attend all
             scheduled visits and compiled with all study procedures.

          -  Covered by health insurance, if required by local regulations.

        Exclusion Criteria:

          -  Participant was pregnant, or lactating, or of childbearing potential and not using an
             effective method of contraception or abstinence from at least 4 weeks prior to
             vaccination until at least 4 weeks after last vaccination. To be considered of
             non-childbearing potential, a female must be pre-menarche.

          -  Previous vaccination against meningococcal disease with either the study vaccine or
             another vaccine (i.e., polysaccharide, or conjugate meningococcal vaccine containing
             serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine), except
             licensed monovalent MenC vaccination received before 2 years of age.

          -  Participation at the time of study enrollment (or in the 4 weeks preceding the first
             study vaccination) or planned participation during the present study period in another
             clinical study investigating a vaccine, drug, medical device, or medical procedure.

          -  Receipt of any vaccine in the 4 weeks preceding any study vaccination or planned
             receipt of any vaccine in the 4 weeks following any study vaccination except for
             influenza vaccination, which might receive at least 2 weeks before study vaccines.
             This exception included monovalent pandemic influenza vaccines and multivalent
             influenza vaccines.

          -  History of vaccination with any tetanus, diphtheria, pertussis, or inactivated polio
             virus vaccine within the previous 3 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.

          -  Known history of diphtheria, tetanus, pertussis, poliomyelitis, and/or HPV infection
             or disease.

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccines used in the study 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.

          -  Personal history of new or past encephalopathy, progressive or unstable neurological
             disorder, or unstable epilepsy.

          -  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 that, in the opinion of the Investigator, is at a stage where it might
             interfere with study conduct or completion.

          -  Moderate or severe acute illness/infection (according to Investigator's judgment) on
             the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [>=
             100.4 degree Fahrenheit]). A prospective participant should not be included in the
             study until the condition had resolved or the febrile event has 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., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study.

          -  Participant at high risk for meningococcal infection during the study (specifically
             but not limited to participants with persistent complement deficiency, with anatomic
             or functional asplenia, or participants traveling to countries with high endemic or
             epidemic disease.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.