Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00381615
First received: September 27, 2006
Last updated: January 4, 2012
Last verified: January 2012

September 27, 2006
January 4, 2012
September 2006
July 2007   (final data collection date for primary outcome measure)
Safety, tolerability and Immunogenicity as measured by serum bactericidal activity of the two vaccines [ Time Frame: at one month after completion of immunization schedule ] [ Designated as safety issue: Yes ]
Safety, tolerabilty and Immunogenicity as measured by serum bactericidal activity of the two vaccines at one month after completion of immunization schedule
Complete list of historical versions of study NCT00381615 on ClinicalTrials.gov Archive Site
Safety, tolerability and Immunogenicity as measured by serum bactericidal activity of the two vaccines at other time points [ Time Frame: 6 months after completion of the immunization schedule ] [ Designated as safety issue: Yes ]
Safety, tolerabilty and Immunogenicity as measured by serum bactericidal activity of the two vaccines at other time points (i.e.6 months after completion of the immunization schedule)
Not Provided
Not Provided
 
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
A Phase 2, Open Label, Multi-Centre, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Two Different Formulations of Novartis Meningococcal B Vaccine When Administered to Healthy Infants

This study is aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy
Biological: Serogroup B meningococcal Vaccine
In this study, healthy infants aged 2 months at enrollment time were randomized in a 2:2:1:1 ratio to receive either 4 doses of Novartis Meningococcal Recombinant Vaccine +/- OMV according to a 2, 4, 6, 12-month schedule or a single dose of Novartis Meningococcal Recombinant Vaccine +/- OMV at 12 months of age. Novartis Meningococcal Recombinant Vaccine +/- OMV is supplied in a pre-filled syringe, 0.5 mL dose.
  • Experimental: Group 1
    "rMenB "Routine vaccinations + Novartis rMenB vaccine 2, 4, 6, and 12 months (rMenB)
    Intervention: Biological: Serogroup B meningococcal Vaccine
  • Experimental: Group 2
    "rMenB + OMV" Routine vaccinations + Novartis rMenB vaccine + OMV NZ 2, 4, 6, and 12 months (rMenB+ OMV)
    Intervention: Biological: Serogroup B meningococcal Vaccine
  • Experimental: Group 3
    "Routine" Routine vaccinations + Novartis rMenB vaccine12 months (rMenB)
    Intervention: Biological: Serogroup B meningococcal Vaccine
  • Experimental: Group 4
    "Routine+OMV" Routine vaccinations + Novartis rMenB vaccine + OMV NZ 12 months (rMenB + OMV)
    Intervention: Biological: Serogroup B meningococcal Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
August 2008
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

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
Both
55 Days to 89 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00381615
V72P6
No
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines - Information Services Novartis
Novartis
January 2012

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