Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00657709
First received: April 2, 2008
Last updated: April 9, 2015
Last verified: April 2015

April 2, 2008
April 9, 2015
March 2008
January 2010   (final data collection date for primary outcome measure)
  • The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination [ Time Frame: one month after the third vaccination ] [ Designated as safety issue: No ]
    The hSBA antibody titer responses, one month after receiving the third vaccination of rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
  • The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined) [ Time Frame: one month after the third vaccination ] [ Designated as safety issue: No ]
    The immunogenicity was assessed in terms of the percentages of subjects who had received the three doses of rMenB+OMV NZ (3 lots combined) given concomitantly with routine infant vaccinations and percentages of subjects who received only the routine infant vaccinations as measured by hSBA titer ≥1:5 following rMenB+OMV NZ vaccinations one month after the third vaccination is reported.
  • Immunogenicity as measured by serum bactericidal activity (SBA) of 3 doses of Meningococcal B vaccine when given to infants concomitantly with routine infant vaccines [ Time Frame: 10 months of study participation, including 6 months safety follow up ] [ Designated as safety issue: No ]
  • Consistency of immune response from 3 lots of Meningococcal B Vaccine (SBA geometric mean titer) [ Time Frame: 10 months of study participation, including 6 months safety follow up ] [ Designated as safety issue: No ]
  • Safety and tolerability of 3 doses of Meningococcal B vaccine when given concomitantly with routine infant vaccines [ Time Frame: 10 months of study participation, including 6 months safety follow up ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00657709 on ClinicalTrials.gov Archive Site
  • The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots) [ Time Frame: 1 month after the third vaccination ] [ Designated as safety issue: No ]
    The immunogenicity was evaluated to assess the consistency of the immune response from three lots of rMenB+OMV NZ in terms of percentage of subjects as measured by hSBA titer ≥1:5 when given to healthy infants at 2, 4, and 6 months of age, at 1 month after the third vaccination.
  • Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ [ Time Frame: 1 Month after the third vaccination ] [ Designated as safety issue: No ]
    The immunogenicity was assessed in terms of prevalence of meningococcal B antibodies as measured by the hSBA, at baseline and at one month after the third vaccination, in the subjects that received routine infant vaccines without rMenB+OMV NZ.
  • Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen) [ Time Frame: 1 month after third vaccination ] [ Designated as safety issue: No ]
    The immunogenicity was evaluated to characterize the immune response against vaccine antigen 287-953, as measured by ELISA at one month after third vaccination.
  • Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations [ Time Frame: 1 month after third vaccination ] [ Designated as safety issue: No ]
    Immunogenicity of the pertussis components (PT, FHA, pertactin) of DTPa-HBV-IPV when given concomitantly with rMenB and PCV7 would be considered non-inferior to that of the routine vaccines given alone if the lower limit of the two-sided CI for the ratio of GMCs one month after third vaccination.
  • Percentages of Subjects With Antibody Response Against the Routine Antigens [ Time Frame: 1 Month after third vaccination ] [ Designated as safety issue: No ]

    The immunogenicity of routine infant vaccines when given concomitantly with rMenB+OMV NZ at 2, 4, and 6 months of age and of the routine infant vaccines given without rMenB+OMV NZ at 1 month after third vaccination with B pertussis, diptheria and tetanus toxoid, H influenza type b, Hepatitis B antigens was measured by ELISA (Enzyme-linked immunosorbent assay) and for polio type 1, type 2 and type 3 by neutralization test (NT)(>=1:8). Diptheria and Tetanus: primary endpoint ELISA >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.

    HepB (HBV):primary endpoint ELISA >=10 mU/mL. PRP-T: primary endpoint ≥ 0.15 mcg/mL and ≥ 1.00 mcg/mL.PNC >=0.35 mcg/ml

  • Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    Immunogenicity was assessed in terms of the percentages of subjects with fourfold increase in antibody concentrations against the routine pertussis antigens FHA (Filamentous Hemagglutinin), Pertactin and PT (Pertussis Toxoid).
  • Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination [ Time Frame: 1 Month after third vaccination ] [ Designated as safety issue: No ]
    Immunogenicity was assessed in terms of the percentages of subjects with fourfold rise in hSBA titers after the three doses of rMenB+OMV NZ (lot 1 or lot 2 or lot 3) vaccination at 2, 4 and 6 months of age.
  • Percentage of Subjects With hSBA Titers ≥1:8 [ Time Frame: 1 month after third vaccination ] [ Designated as safety issue: Yes ]
    Immunogenicity was assessed in terms of the percentages of subjects achieving hSBA titers ≥1:8 at one month after third vaccination with rMenB (lot 1 or lot 2 or lot 3) against the three vaccine strains.
  • Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine [ Time Frame: upto 7 days after any vaccination ] [ Designated as safety issue: Yes ]
    The safety and tolerability of three doses of rMenB+OMV NZ when given concomitantly with routine infant vaccines at 2, 4 and 6 months of age was assessed by the number of subjects reporting solicited local and systemic adverse events.
  • Consistency of immune response from 3 lots of Meningococcal B vaccine, as measured by percentage of subjects with SBA titer ≥1:4 [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Non-inferiority of immunogenicity of routine infant vaccines when given concomitantly with Meningococcal B vaccine to that of routine infant vaccines given alone. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Prevalence of meningococcal B antibodies in the subjects that received routine infant vaccines only. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Serogroup B Meningococcal Meningitis
  • Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
    One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
  • Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
    One dose of rMenB concomitantly with the routinely administered infant vaccines
  • Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
    One dose of rMenB concomitantly with the routinely administered infant vaccines
  • Biological: Infanrix Hexa
    Routine vaccination
  • Biological: Menjugate
    One dose of the routinely administered infant vaccines + MenC vaccine
  • Biological: Prevenar
    Routine vaccination
  • Experimental: rMenB Lot1
    Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
    Intervention: Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
  • Experimental: rMenB Lot2
    Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
    Intervention: Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
  • Experimental: rMenB Lot3
    Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
    Intervention: Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
  • Active Comparator: Routine
    Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
    Interventions:
    • Biological: Infanrix Hexa
    • Biological: Prevenar
  • Active Comparator: MenC + Routine
    Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
    Interventions:
    • Biological: Infanrix Hexa
    • Biological: Menjugate
    • Biological: Prevenar
Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A; EU Meningococcal B Infant Vaccine Study group. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013 Mar 9;381(9869):825-35. Erratum in: Lancet. 2013 Mar 9;381(9869):804.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3630
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy 2-month old infants (55-89 days, inclusive)

Exclusion Criteria:

  • Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens)
  • Previous ascertained or suspected disease caused by N. meningitidis
  • History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
  • Any serious chronic or progressive disease
  • Known or suspected impairment or alteration of the immune system
Both
55 Days to 89 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Finland,   Germany,   Italy
 
NCT00657709
V72P13, EUDRACT 2007-007781-38
Yes
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP