Clinical Trial: Safety and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Open Label, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine

Brief Summary: Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of Novartis Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants in Taiwan.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Immunogenicity: percentage of subjects with SBA titer higher than or equal to 1:5 [ Time Frame: 1 month following the third Vaccination ]
    To demonstrate the sufficiency of the immune response to rMenB+OMV NZ vaccine, when given concomitantly with routine vaccines (i.e DTaP-IPV-Hib, HepB and PCV-13) to healthy infants at 2, 4, 6 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:5 against the indicator strains H44/76, 5/99 and NZ98/254 at 1 month after the third vaccination (at 7 months of age).
  • Safety: assess percentage and numbers of subjects with local and systemic adverse events [ Time Frame: Until Day 7 post-each vaccination ]
    Assess the safety of a 3-dose schedule (at 2, 4, 6 months) of Novartis Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants in Taiwan.
  • Safety: percentage of subjects with SAEs, medically attended AEs and AEs leading to study withdrawal [ Time Frame: Until study end (at 13 months of age) ]


Original Primary Outcome:

  • Immunogenicity: percentage of subjects with SBA titer higher than or equal to 1:5 [ Time Frame: 1 month following the third ]
    To demonstrate the sufficiency of the immune response to rMenB+OMV NZ vaccine, when given concomitantly with routine vaccines (i.e DTaP-IPV-Hib, HepB and PCV-13) to healthy infants at 2, 4, 6 months of age, as measured by percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:5 against the indicator strains H44/76, 5/99 and NZ98/254 at 1 month after the third vaccination (at 7 months of age).
  • Safety: assess percentage and numbers of subjects with local and systemic adverse events [ Time Frame: Until Day 7 post-each vaccination ]
    Assess the safety of a 3-dose schedule (at 2, 4, 6 months) of Novartis Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants in Taiwan.
  • Safety: percentage of subjects with SAEs, medically attended AEs and AEs leading to study withdrawal [ Time Frame: Until study end (at 13 months of age) ]


Current Secondary Outcome:

  • Percentage of subjects with SBA titer higher than or equal to 1:5 [ Time Frame: 1 month following the booster ]
    - To demonstrate the sufficiency of the immune response to a booster dose of rMenB+OMV NZ vaccine when given concomitantly with routine vaccines (i.e. MMR and varicella) to healthy toddlers at 12 months of age that were previously primed with 3-doses of rMenB+OMV NZ, as measured by percentage of subjects with SBA titer ≥ 1:5 against the indicator strains H44/76, 5/99 and NZ98/254 at 1 month after the booster dose (at 13 months of age).
  • SBA GMTs [ Time Frame: Baseline (2 months of age), 1 month after the third vaccination (7 months of age), prior to the booster vaccination (12 months of age), 1 month after the booster vaccination (13 months of age) ]
    To assess bactericidal antibodies against meningococcal B in healthy infants receiving rMenB+OMV NZ concomitantly with routine vaccines (Group A) or routine vaccines alone (Group B) at 2, 4, 6 and 12 months of age, as measured by SBA geometric mean titers (GMTs) and percentage of subjects with SBA titer ≥ 1:5 against indicator strains H44/76, 5/99, NZ98/254 and strain M10713 at baseline (2 months of age), 1 month after the third vaccination (7 months of age), prior to the booster dose (12 months of age) and at 1 month after the booster dose (13 months of age).
  • SBA GMRs [ Time Frame: 1 month after the third vaccination (7 months of age), prior to the booster vaccination (12 months of age), 1 month after the booster vaccination (13 months of age) to Baseline (2 months of age) ]
    To assess bactericidal antibodies against meningococcal B in healthy infants receiving rMenB+OMV NZ concomitantly with routine vaccines (Group A) or routine vaccines alone (Group B) at 2, 4, 6 and 12 months of age, as measured by SBA geometric mean ratios between post and pre-vaccination (baseline) titers (GMRs) and percentage of subjects with SBA titer ≥ 1:5 against indicator strains H44/76, 5/99, NZ98/254 and strain M10713 at baseline (2 months of age), 1 month after the third vaccination (7 months of age), prior to the booster dose (12 months of age) and at 1 month after the booster dose (13 months of age).


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: June 5, 2014
Date Started: September 2014
Date Completion:
Last Updated: December 9, 2016
Last Verified: December 2016