A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Intervention: Novartis MenACWY-CRM; Saline Placebo
Intervention description: All subjects had blood drawn at Day 1 and Day 29.; All subjects had blood drawn at Day 1 and Day 29.
Intervention MeSH terms: Lactitol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 450.0
Sex: All
Minimum age: 11 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; ACWY-CRM; Conjugate Vaccine; Meningitis; Adolescents; Persistence; Adults

Summary:

      This study is designed to evaluate the immunogenicity and the safety of a quadrivalent
      vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.
    

Eligibility criteria:

        Inclusion Criteria:

        Individuals eligible for enrollment in this study were those:

          1. who were 11-55 years of age inclusive and who, after the nature of the study had been
             explained:

               1. had given written assent and/or for whom the parent/legal representative had
                  provided written informed consent (11-19 years of age).

               2. had provided written informed consent (20-55 years of age).

          2. who the investigator believed that they or their parents/legal representatives would
             comply with the requirements of the protocol (e.g., completion of the Diary Card,
             return for follow-up visit).

          3. who were in good health as determined by

               1. medical history

               2. physical assessment

               3. clinical judgment of the investigator

          4. who had negative urine pregnancy test for women of childbearing age.

        Exclusion Criteria:

        Individuals not eligible to be enrolled in the study were those:

          1. who were unwilling or unable to give written informed assent or consent to participate
             in the study.

          2. who were perceived to be unreliable or unavailable for the duration of the study
             period.

          3. who were planning to leave the area of the study site before the end of the study
             period.

          4. who had a previous or suspected disease caused by N. meningitidis.

          5. who had household contact with and/or intimate exposure to an individual with
             culture-proven N. meningitidis infection within 60 days prior to enrollment.

          6. who had previously been immunized with a meningococcal vaccine.

          7. who had received any investigational or non-registered product (drug or vaccine)within
             28 days prior to enrollment or who expected to receive an investigational drug or
             vaccine prior to the completion of the study.

          8. who had received any licensed vaccines within 14 days (for inactivated vaccines) or 28
             days (for live vaccines) prior to enrollment in this study or who were planning to
             receive any vaccine within 30 days from the study vaccines. (Exception: Influenza
             vaccine was administered up to 15 days prior to study vaccination and at least 15 days
             after study vaccination)

          9. who had experienced within the 7 days prior to enrollment significant acute or chronic
             infection (for example requiring systemic antibiotic treatment or antiviral therapy)
             or had experienced fever (defined as body temperature ≥38°C) within 3 days prior to
             enrollment.

         10. who had any serious acute, chronic or progressive disease (e.g., any history of
             neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or
             AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe
             malnutrition).

         11. who had epilepsy or any progressive neurological disease.

         12. who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any
             vaccine components, including latex allergies.

         13. who had a known or suspected impairment/alteration of immune function, either
             congenital or acquired or resulting from (for example):

               1. received immunosuppressive therapy within 28 days prior to enrollment(any
                  systemic corticosteroid administered for more than 5 days, or in a daily dose > 1
                  mg/kg/day prednisone or equivalent during any of 28 days prior to enrollment, or
                  cancer chemotherapy)

               2. received immunostimulants

               3. received parenteral immunoglobulin preparation, blood products, and/or plasma
                  derivatives within 90 days prior to enrollment and for the full length of the
                  study

         14. who were known to have a bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time.

         15. who had any condition that, in the opinion of the investigator, might interfere with
             the evaluation of the study objectives.