Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia

Inclusion Criteria:

Individuals eligible for enrollment in this study are those:

1. Who are of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study has been described and:

   • the parent/legal representative has provided written informed consent (≥2 to <18 years of age),
   • have provided written assent (≥11 to <18 years of age),
   • have provided written informed consent (≥18 years of age onwards).
2. Who the investigator believes that the subject and/or his or her parent/legal representative 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 from 11 years of age.

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 confirmed 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 or vaccine containing meningococcal antigen(s) (licensed or investigational).
6. Who are pregnant or breast feeding (female subjects).
7. 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.

8. 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).

9. 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 ≥ 38°C) within 3 days prior to enrollment.
10. 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). Who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
11. Who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components including diphtheria toxin (CRM-197) and latex in the syringe.

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 30 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 30 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.