A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

• Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]
  The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)
• Percentage of Seroresponders, Ages 11 to 18 Years [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

  Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).

  Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

• Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years [ Time Frame: 6 days after vaccination ] [ Designated as safety issue: Yes ]

  Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.

  Note: severe adverse events: unable to perform normal daily activity

• Percentage of Seroresponders, Ages 19 to 55 Years [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

  Immunogencity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed menigococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meninitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age).

  Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

• Immunogenicity of Novartis MenACWY compared with immunogenicity of a single dose of licensed meningococcal ACWY conjugate vaccine defined as measured by serum bactericidal activity one month after vaccination.
• Safety of Novartis MenACWY compared with that of licensed meningococcal ACWY conjugate vaccine as measured by the percentage of subjects presenting at least one severe systemic reaction during the first 7 days (Day 1-7) following a single dose.
• To assess the consistency of 3 manufactured lots as measured by geometric mean titers of serum bactericidal antibodies measured one month after vaccination.

• Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

  The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).

  Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

• Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]

  Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).

  Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

• Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years [ Time Frame: 28 days after vaccination ] [ Designated as safety issue: No ]
  Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).
• Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: Yes ]
  Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).

This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.

• Meningococcal Infections
• Meningococcal Meningitis

• Biological: MenACWY CRM
  One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
• Biological: Meningococcal ACWY Conjugate vaccine
  One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.

• Active Comparator: Licensed Meningococcal Vaccine
  Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
  Intervention: Biological: Meningococcal ACWY Conjugate vaccine
• Experimental: Novartis MenACWY Conjugate Vaccine
  Novartis meningococcal ACWY conjugate Vaccine
  Intervention: Biological: MenACWY CRM

Inclusion Criteria:

• Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent

Exclusion Criteria:

• Subjects with a previous or suspected disease caused by N. meningitidis
• previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
• previous or suspected disease caused by N. meningitidis
• Any serious acute, chronic or progressive disease
• Pregnant or breastfeeding