Novartis Meningococcal ACWY conjugate vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis serogroups A, C, W and Y. MedDRA version: 17.1 Level: PT Classification code 10027280 Term: Meningococcal sepsis System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.1 Level: PT Classification code 10027249 Term: Meningitis meningococcal System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.1 Level: LLT Classifi
Conditions
Interventions
Trade Name: Menveo
Product Code: V59
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Meningococcal group A oligosaccharide 10 µg
Other descriptive name: MENINGO
Sponsors
Novartis Vaccines & Diagnostics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent. Are the trial subjects under 18? yes Number of subjects for this age range: 1636 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1332 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Show consistency of immune response for 3 lots of MenACWY as measured by serum bactericidal activity geometric mean titer response against serogroups A, C, W, Y (11 to 18 years); 2) Compare immunogenicity of a single dose MenACWY (3 lots) and a single dose of Menactra as measured by the percentage of subjects with seroresponse against serogroups A, C, W, Y (11 to 18 years); 3) Compare immunogenicity of a single dose of MenACWY (3 lots) and a single dose of Menactra, as measured by percentage of subjects with seroresponse against serogroups A, C, W, Y (19 to 55 years). 4) Compare percentages of healthy subjects 11 to 55 years of age with at least one severe systemic reaction between day 1 and 7 following a single dose of MenACWY (3 lots combined) versus a single dose of Menactra.;Secondary Objective: 1) Consistency of immune response for three lots of MenACWY, by percentage of subjects with seroresponse, hSBA titer = 1:4 and = 1:8, against serogroups A, C, W, Y (11 to 18 years); 2) Immunogenicity of one dose of MenACWY (3 lots) compared to one dose of Menactra; the percentage of subjects with seroresponse directed against serogroups A, C, W, Y (11 to 55 years); 3) Immunogenicity of one dose of MenACWY (3 lots) compared to one dose of Menactra; the percentage of subjects with hSBA = 1:4 and = 1:8, against serogroups A, C, W, Y (11 to 55 years); 4) Immunogenicity of one dose of MenACWY (3 lots ) compared to one dose of Menactra, by hSBA GMTs against serogroups A, C, W, Y (11 to 55 years). 5) Compare MenACWY to Menactra in terms of immediate hypersensitivity reactions, local and systemic reactions (day 1-7), AEs (day 1-29), medically significant AEs (day30-180), SAEs (day 1-180).;Primary end point(s): 1) Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years 2) Percentage of Seroresponders, Ages 11 to 18 Years 3) Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years 4) Pe | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Lot to Lot Consistency as measured by the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer = 1:8, and = 1:4, Ages 11 to 18 Years 2) Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer = 1:8, and hSBA Titer = 1:4, Ages 11 to 55 Years 3) Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years 4) Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years;Timepoint(s) of evaluation of this end point: 1) 28 days after vaccination 2) 28 days after vaccination 3) 28 days after vaccination 4) Days 1 to 7 | — |
Countries
United States
Contacts
Public ContactPosting Director
Novartis Vaccines & Diagnostics, Inc.
Outcome results
None listed