Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM
Intervention description: 1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; children; adolescents; adults; MenACWY

Summary:

      To evaluate the immune response and safety following a single dose of Novartis Meningococcal
      ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.
    

Eligibility criteria:

        Inclusion Criteria:

        Individuals eligible for enrollment in this study were those:

          1. Who were 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 had been described and:

               -  the parent/legal representative had provided written informed consent (≥2 to <18
                  years of age),

               -  had provided written assent (≥11 to <18 years of age),

               -  had provided written informed consent (≥18 years of age onwards).

          2. Who the investigator believed that the subject and/or his or her parent/legal
             representative could and 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

               -  medical history

               -  physical exam

               -  clinical judgment of the investigator

          4. Who had a negative urine pregnancy test for female subjects from 11 years of 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 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 had previously been immunized with a meningococcal vaccine or vaccine containing
             meningococcal antigen(s) (licensed or investigational).

          6. Who were pregnant or breast feeding (female subjects).

          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 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 might be 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 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, Human
             immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS),
             or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition).
             Who had epilepsy or any progressive neurological disease or history of Guillain-Barre
             syndrome.

         11. Who had 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 had 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 were known to have a bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time.