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 13, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Serogroup B Meningococcal Meningitis
Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
Biological: Infanrix Hexa
Biological: Menjugate
Biological: Prevenar
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 3630
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
One dose of rMenB Lot concomitantly with the routinely administered infant vaccines
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.
Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
One dose of rMenB concomitantly with the routinely administered infant vaccines
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.
Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
One dose of rMenB concomitantly with the routinely administered infant vaccines
Active Comparator: Routine
Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
Biological: Infanrix Hexa
Routine vaccination
Biological: Prevenar
Routine vaccination
Active Comparator: MenC + Routine
Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
Biological: Infanrix Hexa
Routine vaccination
Biological: Menjugate
One dose of the routinely administered infant vaccines + MenC vaccine
Biological: Prevenar
Routine vaccination

  Eligibility

Ages Eligible for Study:   55 Days to 89 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657709

  Show 66 Study Locations
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00657709     History of Changes
Other Study ID Numbers: V72P13, EUDRACT 2007-007781-38
Study First Received: April 2, 2008
Results First Received: February 13, 2015
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Czech Republic: State Institute for Drug Control
Austria: Federal Office for Safety in Health Care

Keywords provided by Novartis:
infant
Meningococcal disease
prevention
vaccination

Additional relevant MeSH terms:
Meningitis, Meningococcal
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on May 05, 2015