Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)
Intervention description: One intramuscular injection of MenACWY at Day 1.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 704.0
Sex: All
Minimum age: 15 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease; Booster vaccination; Meningitis; Antibody persistence

Summary:

      The purpose/aim of this study is to assess the safety and antibody response to vaccination
      with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess
      the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Individuals of 15 through 55 years of age on the day of informed consent or assent.

          2. Individuals who received Menveo 4 to 6 years prior to enrolment at an age of 11 years
             or older OR Individuals who received Menactra 4 to 6 years prior to enrolment at an
             age of 11 years or older OR Individuals who have not received any previous
             meningococcal vaccine.

          3. Individuals who have voluntarily given written informed consent after the nature of
             the study has been explained according to local regulatory requirements, prior to
             study entry. If the subject is under age 18 at the time of enrolment, the
             parent(s)/legal guardian(s) of the subject should have voluntarily given written
             informed consent.

          4. Individuals who can comply with study procedures including follow-up.

          5. Males Or Females of non-childbearing potential Or

               -  Females of childbearing potential who are using an effective birth control method
                  which they intend to use for at least 30 days after the study vaccination.

        Exclusion Criteria:

        Each subject must not have:

          1. History of any meningococcal vaccine administration other than the single vaccination
             given 4 to 6 years before OR History of any meningococcal vaccine administration.

          2. Current or previous, confirmed or suspected disease caused by N. meningitidis.

          3. Household contact with and/or intimate exposure to an individual with any laboratory
             confirmed N. meningitidis infection within 60 days prior to study vaccination.

          4. Progressive, unstable or uncontrolled clinical conditions.

          5. Hypersensitivity, including allergy, to any component of vaccines, medicinal products
             or medical equipment whose use is foreseen in this study.

          6. Clinical conditions representing a contraindication to intramuscular vaccination (IM)
             and blood draws.

          7. Abnormal function of the immune system resulting from:

               1. Clinical conditions.

               2. Systemic administration of corticosteroids for more than 14 consecutive days
                  within 90 days prior to study vaccination.

               3. Administration of antineoplastic and immunomodulating agents or radiotherapy
                  within 90 days prior to study vaccination.

          8. Received immunoglobulins or any blood products within 180 days prior to informed
             consent.

          9. Received systemic antibiotic treatment within 3 days prior to study vaccination or
             blood draw.

         10. Received an investigational or non-registered medicinal product within 30 days prior
             to study vaccination.

         11. Study personnel as an immediate family or household member.

         12. Individuals who have received any other vaccines within 7 days or 14 days prior to
             vaccination in this study or who are planning to receive any vaccine within 28 days
             from the study vaccination.

         13. Individuals who have experienced a moderate or severe acute infection and/or fever
             defined as a temperature ≥38°C (100.4°F) within 3 days prior to study vaccination.

         14. Any other clinical condition that, in the opinion of the investigator, might pose
             additional risk to the subject due to participation in the study.