Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

Novartis Vaccines60 enrolled

Overview

To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Meningococcal Disease

Interventions

rMenBBIOLOGICAL

One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.

rMenB+OMVBIOLOGICAL

One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 8 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy 6-8 months old infants Exclusion Criteria: * previous receipt of any meningococcal B vaccine; * previous ascertained or suspected disease caused by N meningitidis; * history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; * any present or suspected serious acute or chronic disease * known or suspected autoimmune disease or impairment /alteration of immune function

Locations (1)

Unnamed facility

Oxford, United Kingdom

Outcomes

Primary Outcomes

Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).

Time frame: Baseline and one month after second and third vaccination

Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).

Time frame: Baseline and one month after second and third vaccination

Secondary Outcomes

Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).

Time frame: One month after second and third vaccination

Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ

Data from ClinicalTrials.gov

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