Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India
Condition: Bacterial Meningitis
MeSH terms: Meningitis, Bacterial; Meningitis
Intervention: Meningococcal ACWY conjugate vaccine
Intervention description: All subjects received a single dose of Meningococcal ACWY conjugate vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 2 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal,; ACWY,; bacterial meningitis,; conjugate vaccine,; healthy, children,; adolescents,; adults,; India

Summary:

      This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal
      ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.
    

Eligibility criteria:

        Inclusion Criteria:

        Individuals eligible for enrollment in this study are those:

          1. who are of any gender, from the age of 2 to 75 years at the time of visit 1, and to
             whom the nature of the study has been explained and:

               -  the parent/legal representative has provided written informed consent (greater
                  than or equal to 2 - less than 18 years of age).

               -  have provided written assent (greater than or equal to 7-less than or equal to 18
                  years)

               -  have provided written informed consent (greater than or equal to 18 to 75 years
                  of age).

          2. who the investigator believes that they or their parents/legal representatives can and
             will comply with the requirements of the protocol (e.g., completion of the Diary Card,
             return for follow-up visit).

          3. who are in good health as determined by medical history, physical exam, clinical
             judgment of the investigator

          4. who have a negative urine pregnancy test for female subjects of childbearing
             potential.

        Exclusion Criteria:

        Individuals not eligible to be enrolled in the study are those:

          1. who are unwilling or unable to give written informed assent or consent to participate
             in the study.

          2. who are perceived to be unreliable or unavailable for the duration of the study
             period.

          3. who had a previous or suspected disease caused by N. meningitidis.

          4. who had household contact with and/or intimate exposure to an individual with
             culture-proven N. meningitidis infection within 60 days prior to enrollment.

          5. who have previously been immunized with a meningococcal vaccine.

          6. who have received any investigational or non-registered product (drug or
             vaccine)within 28 days prior to enrollment or who expect to receive an investigational
             drug or vaccine prior to the completion of the study.

          7. who have received any vaccines within 14 days (for inactivated vaccines) or 28 days
             (for live vaccines) prior to enrollment in this study or who are planning to receive
             any vaccine within 30 days from the study vaccines. (Exception: Influenza vaccine may
             be administered up to 15 days prior to study vaccination and at least 15 days after
             study vaccination)

          8. who have experienced within the 7 days prior to enrollment significant acute infection
             (for example requiring systemic antibiotic treatment or antiviral therapy) or have
             experienced fever (defined as body temperature greater than or equal to 38°C) within 3
             days prior to enrollment.

          9. who have 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).

         10. who have epilepsy or any progressive neurological disease.

         11. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any
             vaccine components.

         12. who have a known or suspected impairment/alteration of immune function, either
             congenital or acquired or resulting from (for example):

               -  receipt of immunosuppressive therapy within 28 days prior to enrollment (any
                  systemic corticosteroid administered for more than 5 days, or in a daily dose
                  greater than 1 mg/kg/day prednisone or equivalent during any of 28 days prior to
                  enrollment, or cancer chemotherapy)

               -  receipt of immunostimulants

               -  receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
                  derivatives within 90 days prior to enrollment and for the full length of the
                  study.

         13. who are known to have a bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time.

         14. who have any condition that, in the opinion of the investigator, might interfere with
             the evaluation of the study objectives.