Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Intervention description: Subjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 465.0
Sex: All
Minimum age: 7 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis

Summary:

      In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody
      persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10
      years of age, and to evaluate response to a booster dose administered 5 years after primary
      vaccination in the parent study V59P20 (NCT00616421).
    

Eligibility criteria:

        Inclusion Criteria:

        In order to participate in this study, all subjects must meet ALL of the inclusion criteria
        described.

          1. Subject has (a) parent(s) or legal guardian(s) who has/have given written consent
             after the nature of the study has been explained according to local regulatory
             requirements.

          2. If the subject is of an age where, according to local regulations, informed assent is
             required, that subject has provided assent to participate in the study.

          3. Subject is in good health as determined by the outcome of medical history, physical
             examination, and clinical judgment of the investigator.

          4. A negative urine pregnancy test is required before female subjects of childbearing
             potential will be enrolled. Of childbearing potential is defined as status post onset
             of menarche and not meeting any of the following conditions: menopausal for at least 2
             years, status after bilateral tubal ligation for at least 1 year, status after
             bilateral oophorectomy, or status after hysterectomy.

          5. For subjects who participated in study V59P20 (Groups MenACWYCRM_ 2 (≥7-≤10 Years),
             MenACWYCRM_1 (≥7-≤10 Years) and MenACWYCRM_ 1 (≥11-≤15 Years) only):

               -  subject who enrolled in Groups MenACWYCRM_2 (≥7-≤10 Years), MenACWYCRM_1 (≥7-≤10
                  Years) and MenACWYCRM_1 (≥11-≤15 Years) of study V59P20, has completed this study
                  and included in per protocol immunogenicity analysis;

               -  the date of first vaccination in study V59P20 occurred 54 to 66 months prior to
                  the collection of the blood sample at Visit 1.

          6. For vaccine-naive subjects (Groups Vaccine Naive(≥7-≤10Years) and Vaccine Naive
             (≥11-≤15 Years) only):

               -  Individual is a male or female 7 to 10 years of age (group Vaccine
                  Naive(≥7-≤10Years)) or 11 to 15 years of age (Group Vaccine Naive (≥11-≤15
                  Years)).

        Exclusion Criteria:

        In order to participate in this study, all subjects must meet NONE of the exclusion
        criteria described.

          1. If the subject is female of childbearing potential, sexually active, and has not used
             any of the acceptable contraceptive methods for at least 2 months prior to study entry
             and for the duration of the trial.

          2. Subject is a pregnant or breast-feeding female.

          3. Subjects' parents or legal guardians or subjects who are not able to comprehend and to
             follow all required study procedures for the whole period of the study.

          4. History of documented or suspected invasive meningococcal disease.

          5. Previous household contact with and/or intimate exposure to an individual with
             laboratory proven N. meningitidis infection within 60 days prior to enrollment and for
             the duration of the study.

          6. Have received any other meningococcal vaccine since participation in V59P20 or, if
             vaccine-naive subjects, have not received any meningococcal vaccine since birth.

          7. Suspected or known hypersensitivity reaction after a previous dose of Menveo, any
             component of this vaccine, including any other CRM197 and diphtheria toxoid.

          8. Any contraindication or precaution against vaccination with Novartis Menveo™ vaccine
             as highlighted in the package insert.

          9. Serious, chronic, or acute illnesses or diseases (i.e., cardiac, renal, neurologic,
             rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system).

         10. Any confirmed or suspected condition with impaired/altered function of immune system
             (immunodeficient or autoimmune conditions).

         11. Administration of any cancer chemotherapy, immune-modified or immunosuppressive agents
             or systemic corticosteroids for at least seven days at any dose in the past 12 weeks
             or planned use throughout the study period (nasal or inhaled steroids are permitted,
             as are steroids applied to the skin).

         12. Administration of blood, blood products and/or plasma derivatives or any
             immunoglobulin preparation in the past 12 weeks or planned use throughout the study
             period.

         13. Administration of any vaccine within 28 days prior to the study enrollment or planned
             administration during the study period.

         14. Subjects participating in any clinical trial with another investigational product 28
             days prior to first study visit or intent to participate in another clinical study at
             any time during the study period.

         15. Subjects who have experienced a significant acute infection requiring systemic
             antibiotic treatment within the 5 days prior to enrolment or have experienced a body
             temperature ≥38°C (≥100.4°F) within the 3 days before the intended study vaccination.

         16. Any condition which, in the opinion of the investigator, would pose a health risk to
             the participant.