Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: MenACWY
Intervention description: Four Intramuscular doses of MenACWY vaccine at 2, 4, 6 and 12 months of age followed by two blood samples at 13 and 24 months of age.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 2 Months
Maximum age: 24 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will
      be provided information about the trial. If interested and if eligible, they will then be
      asked to provide signed informed consent. The initial study visit can occur immediately after
      signed informed consent has been obtained. Approximately 135 subjects will be enrolled to
      receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy male and female 2 month-old infants (55 - 89 days) on the day of consent.

          2. Infants whose parents or legal guardians have voluntary given written informed consent
             after the nature of the study has been explained according to local regulatory
             requirements, prior to study entry.

          3. Infants whose parents or legal guardians can comply with study procedures including
             follow-up

        Exclusion Criteria:

          1. Previously received any meningococcal A, C, W and Y vaccines.

          2. Previous confirmed or suspected disease caused by N. meningitidis or who have had
             household contact with and/or intimate exposure to an individual with laboratory
             confirmed N. meningitidis infection at any time since birth.

          3. Progressive, unstable or uncontrolled clinical conditions.

          4. A history of anaphylactic shock, asthma, urticaria or other allergic reaction after
             previous vaccinations or known hypersensitivity to any vaccine component, such as
             latex allergy.

          5. Experienced significant acute or chronic infection within the previous 7 days or have
             experienced fever (temperature ≥ 38.0°C [100.4°F]) within the previous 3 days.

          6. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          7. Received treatment with systemic administration corticosteroids (PO/IV/IM) for more
             than 14 consecutive days from birth

          8. Ever received blood, blood products and/or plasma derivatives or any parenteral
             immunoglobulin preparation (including Hepatitis B immune globulin) at any time since
             birth and for the full length of the study.

          9. Any bleeding disorder which is considered as a contraindication to intramuscular
             injection or blood draw.

         10. Any condition which, in the opinion of the investigator, might interfere with the
             results of the study or pose additional risk to the subject due to participation in
             the study.

         11. Received or are planning to receive any investigational or non-registered medicinal
             product from birth and throughout the study.

         12. Received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled
             blood draw (topical antibiotics are acceptable, including antibiotic eye drops).

         13. Relatives of site research staff working on this study.