Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenABCWY+OMV; MenABCWY+¼OMV; Placebo
Intervention description: Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a "full" dose) plus the fully lyophilized MenACWY vaccine; Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine; Saline solution for injection (0.5mL)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; Booster; MenABCWY; Menveo; Vaccine Adolescents; Immune Response; N. Meningitidis

Summary:

      The purpose of this extension study is to evaluate the immunogenicity and safety of a booster
      dose of a MenABCWY vaccine, administered 24 months after completion of the primary
      vaccination series, in subjects who previously received the same vaccine formulation in study
      V102_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the
      primary vaccination and 12 months after the booster dose will also be evaluated in these
      subjects.

      In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations
      (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously
      received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV).
      These subjects will be followed for safety and immunogenicity for 12 months after vaccination
      in study V102_03E1.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females that received both vaccinations and completed the Study Termination
             visit in the primary study, V102_03 (NCT01272180);

          2. Individuals or the individual's parents or legal guardian who have given written
             consent after the nature of the study has been explained according to local regulatory
             requirements;

          3. Individuals who have given written assent as required by local regulations after the
             nature of the study has been explained to them according to local regulatory
             requirements;

          4. Individuals in good health as determined by the outcome of medical history, physical
             examination and clinical judgment of the investigator;

          5. Individuals and/or or the individual's parents or legal guardian who can comply with
             study procedures and are available for follow-up.

        Exclusion Criteria:

          1. History of any meningococcal vaccine administration other than the vaccination
             administered in the primary study, V102_03 (NCT01272180);

          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 of enrollment;

          4. History of severe allergic reactions after previous vaccinations or hypersensitivity
             to any vaccine component;

          5. All sexually active females that have not used an "acceptable contraceptive method(s)"
             for at least 2 months prior to study entry. Acceptable birth control methods are
             defined as one or more of the following:

               1. Hormonal contraceptive (such as oral, injection, transdermal patch, implant,
                  cervical ring)

               2. Barrier (condom with spermicide or diaphragm with spermicide) each and every time
                  during intercourse

               3. Intrauterine device (IUD)

               4. Monogamous relationship with vasectomized partner. Partner must have been
                  vasectomized for at least six months prior to the subject's study entry;

          6. Sexually active females that refuse to use to an "acceptable contraceptive method"
             through to 3 weeks following the study vaccination;

          7. Female subjects with a positive pregnancy test prior to the study vaccine being
             administered;

          8. Nursing (breastfeeding) mothers;

          9. Individuals with a history of illness or with an ongoing illness that, in the opinion
             of the investigator, may pose additional risk to the subject if he/she participates in
             the study;

         10. Any serious, chronic, or progressive disease (e.g., neoplasm, diabetes, cardiac
             disease, hepatic disease, progressive neurological disease or seizure disorder;
             autoimmune disease, HIV infection or AIDS, blood dyscrasias, bleeding diathesis, signs
             of cardiac or renal failure, or severe malnutrition);

         11. Subjects who required chronic administration (defined as more than 14 days) of
             immunosuppressants or other immune-modifying drugs within six months prior to the
             study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥
             20mg/day. Inhaled and topical steroids are allowed).

         12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral
             immunoglobulin preparation within the previous 90 days;

         13. Individuals participating in any clinical trial with another investigational product
             30 days prior to first study visit or intent to participate in another clinical study
             at any time during the conduct of this study;

         14. Administration or planned administration, of any vaccine not foreseen by the study
             protocol within 30 days prior study vaccination, and up to 30 days after the
             vaccination (with the exception of any licensed influenza vaccine which may be
             administered >14 days preceding or >14 days following the study vaccination);

         15. Individuals who study personnel or immediate family members of study personnel
             including brother, sister, child, parent, or the spouse.

         16. Individuals who have experienced moderate or severe acute infection and/or fever
             (defined as temperature ≥ 38°C) within 3 days prior to enrolment.

         17. Who have received systemic antibiotic treatment within 7 days prior to enrollment.