Who is sponsoring NCT01272180?

NCT01272180 is sponsored by Novartis Vaccines.

What condition does NCT01272180 study?

NCT01272180 studies Invasive Meningococcal Disease.

What drugs are being tested in NCT01272180?

Interventions: Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV., Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV., Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine., Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV..

What is the status of NCT01272180?

NCT01272180 is currently COMPLETED.

Last reviewed 2020-06-11 · How we verify

Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents and Young Adults to Evaluate Safety and Immunogenicity of Two Different rMenB With OMV + MenACWY Combination Vaccination Formulations

NCT01272180 Phase 2 COMPLETED Results posted

This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 2
Status	COMPLETED
Enrolment	484
Start date	2011-08
Completion	2012-09

Conditions

Invasive Meningococcal Disease

Interventions

Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.
Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.

Primary outcomes

Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. — One month after the second vaccination (Day 91)
Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y. Seroresponse is defined as: 1. For subjects with a pre-vaccination hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; 2. For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer. Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA).
Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters. — One month after the second vaccination (Day 91)
The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation.

Countries

United States, Poland