A Study to Evaluate 4-year Antibody Persistence and Booster Response Following MenABCWY Vaccination in Healthy Adolescents and Young Adults Who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)
Condition: Meningococcal Disease; Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: MenABCWY+OMV vaccine
Intervention description: Intramuscular injection of a single dose at Day 1 to subjects in the MenABCWY+OMV Group or as a 2 doses at Day 1 and Day 31, one month apart, to subjects in the MenACWY and Naive Groups.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 15 Years
Maximum age: 23 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Antibody persistence; Young Adults; Healthy Adolescents; MenABCWY vaccine; Booster response; MenABCWY+OMV

Summary:

      The purpose of this study is to evaluate persistence of bactericidal antibodies for N.
      meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years
      after primary vaccination in subjects who previously received a 2-dose series of
      MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune
      response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30
      days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a
      2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune
      response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated
      subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after
      an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive
      subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive
      subjects and subjects who previously received one dose of MenACWY
    

Eligibility criteria:

        Inclusion Criteria:

          1. Individuals who received either 2 doses of MenABCWY+OMV or a single dose of MenACWY
             followed by a dose of placebo, with the last study vaccine given approximately 48 to
             56 months before study V102_02E2 (NCT01367158), who received Tdap only in V102_02E1
             (NCT01367158) study and who received no other meningococcal vaccines; Or A
             proportional number of subjects in each site aged 15 through 23 years on the day of
             informed consent/assent who did not participate in the V102_02 (NCT01210885) study and
             have not previously received any meningococcal vaccine.

          2. Individuals who / whose parent(s)/legal guardian(s) have voluntarily given written
             informed consent/assent after the nature of the study has been explained according to
             local regulatory requirements, prior to study entry.

          3. Individuals who can comply with study procedures including blood draws and follow-up.

          4. Males Or Females of non-childbearing potential Or Females of childbearing potential
             who are not pregnant or breastfeeding and who are using an effective birth control
             method which they have used for at least 30 days prior to study entry, and which they
             intend to use for at least 30 days after the last study vaccination

        Exclusion Criteria:

          1. History of any meningococcal vaccine administration (study group C) or History of any
             meningococcal vaccine administration other than vaccination given in the parent
             V102_02 (NCT01210885) study (study groups A and B).

          2. Progressive, unstable or uncontrolled clinical conditions.

          3. Hypersensitivity, including allergy, to any component of vac-cines (including
             diphtheria toxoid (CRM197) and latex) whose use is foreseen in this study.

          4. Clinical conditions representing a contraindication to intra-muscular vaccination and
             blood draws.

          5. Abnormal function of the immune system resulting from:

             a.Clinical conditions.

          6. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive
             days within 90 days prior to enrollment.

          7. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90
             days prior to informed consent.

          8. Received immunoglobulins or any blood products within 90 days prior to enrollment.

          9. Received an investigational or non-registered medicinal product within 30 days prior
             to enrollment.

         10. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for
             live vaccines) prior to enrolment in this study or who are planning to receive any
             vaccine within 14 days from the study vaccines.

         11. Study personnel as an immediate family or household member.

         12. Who have experienced a moderate or severe acute infection and/or fever (defined as
             temperature 38°C) within 3 days prior to enrollment.

         13. Who have received systemic antibiotic treatment within 3 days prior to enrollment.

         14. Any other clinical condition that, in the opinion of the investigator, might interfere
             with the results of the study or pose additional risk to the subject due to
             participation in the study.