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

Overview

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

Full Title of Study: “A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, When Administered to Healthy Infants 6-8 Months Old”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2007

Interventions

  • Biological: rMenB
    • 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.
  • Biological: rMenB+OMV
    • 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.

Arms, Groups and Cohorts

  • Experimental: rMenB
    • 6-8 months-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and 12 months of age.
  • Experimental: rMenB+OMV
    • 6-8 months-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and 12 months of age.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: Baseline and one month after second and third vaccination
    • 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).
  • 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
    • Time Frame: Baseline and one month after second and third vaccination
    • 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).

Secondary Measures

  • 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
    • Time Frame: One month after second and third vaccination
    • 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).
  • Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
    • Time Frame: Baseline and one month after second and third vaccination
    • The immune response was measured as the geometric mean bactericidal titers directed 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).
  • Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
    • Time Frame: Baseline and one month after second and third vaccination
    • The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), 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).
  • Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ
    • Time Frame: One month after second and third vaccination
    • Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
  • Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ
    • Time Frame: Day 1 through day 7 after each vaccination
    • Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 8 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Novartis Vaccines
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Vaccines (formerly Chiron Vaccines) Novartis, Study Chair, Novartis Vaccines

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