A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: MenACWY liquid; MenACWY
Intervention description: At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm.; At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY_1) or in phase 2 of the study (subjects randomized to study arm ACWY_2), administered by intramuscular injection in the deltoid of the non-dominant arm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Data will be collected in an observer-blind manner. By observer-blind, it is meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity and immunogenicity) will all be unaware of which vaccine was administered. To do so, vaccine preparation and administration will be done by authorized medical personnel who will not participate in any of the study clinical evaluations.
Enrollment: 1707.0
Sex: All
Minimum age: 10 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal disease; Liquid formulation; Meningitis

Summary:

      MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by
      meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more
      than 60 countries.

      The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY
      vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by
      storage at 2-8ºC.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects who, in the opinion of the investigator, can and will comply with the
             requirements of the protocol or subjects' parent(s)/Legally Acceptable
             Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will
             comply, with the requirements of the protocol.

          2. Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the
             subject prior to performing any study specific procedure.

          3. Written informed assent obtained for subjects below legal age of consent, if required
             by local regulations at the time of the enrolment.

          4. A male or female ≥10 to ≤40 YoA at the time of the vaccination.

          5. Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          6. Female subjects of non-childbearing potential may be enrolled in the study.

               -  Non-childbearing potential is defined as pre-menarche, current bilateral tubal
                  ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause

          7. Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception for 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue adequate contraception during the entire treatment period.

        Exclusion Criteria:

          1. Child in care

          2. Anaphylaxis following the administration of vaccine.

          3. Any (clinical) condition that in the judgment of the investigator would make
             intramuscular injection unsafe &/represents a contraindication to intramuscular
             vaccination and blood draws.

          4. Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             HIV infection.

          5. Progressive, unstable or uncontrolled clinical conditions.

          6. Hypersensitivity, including allergy, to any component of vaccines, medicinal products
             or medical equipment whose use is foreseen in this study.

          7. Hypersensitivity to the active substances or to any of the excipients of the vaccine,
             including diphtheria toxoid (CRM197), or a life-threatening reaction after previous
             administration of a vaccine containing similar components.

          8. Abnormal function of the immune system resulting from:

               -  Clinical conditions.

               -  Systemic administration of corticosteroids within 90 days prior to informed
                  consent, and until the Day 29 blood draw.

               -  Administration of antineoplastic and immunomodulating agents or radiotherapy
                  within 90 days prior to informed consent, and until the Day 29 blood draw.

          9. Received immunoglobulins or any blood products within 180 days prior to informed
             consent.

         10. Received an investigational or non-registered medicinal product within 30 days prior
             to informed consent.

         11. Any other clinical condition that, in the opinion of the investigator, might pose
             additional risk to the subject due to participation in the study.

         12. History of any meningococcal vaccination, with the exception of previous meningococcal
             C vaccination, if the last dose of MenC was received at ≤24 months of age.

         13. Individuals who received any other vaccines within 7 days (for inactivated vaccines)
             or 14 days prior to enrolment in this study or who are planning to receive any vaccine
             within 28 days from the study vaccines.*

             * In case an emergency mass vaccination for an unforeseen public health threat is
             organized by the public health authorities, outside the routine immunization program,
             the time period described above can be reduced if necessary for that vaccine provided
             it is licensed and used according to its Prescribing Information and according to the
             local governmental recommendations and provided a written approval of the sponsor is
             obtained.

         14. Administration of long-acting immune-modifying drugs at any time during the study
             period (e.g. infliximab).

         15. Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational vaccine/product (pharmaceutical product or device).

         16. Current or previous, confirmed or suspected disease caused by N. meningitidis.

         17. Household contact with and/or intimate exposure to an individual with any laboratory
             confirmed N. meningitidis infection within 60 days prior to study vaccination.

         18. Acute disease and/or fever within 3 days prior to study vaccination. Note: enrolment
             may be postponed/delayed until such transient circumstances have ended.

               -  Fever is defined as body temperature ≥38.0°C/100.4°F. The preferred location for
                  measuring temperature in this study will be the oral cavity.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.

         19. Received systemic antibiotic treatment within 3 days prior to study vaccination or
             blood draw.

         20. Study personnel as an immediate family or household member.

         21. Pregnant or lactating women.