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
  Purpose

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


Condition Intervention Phase
Healthy
Biological: Serogroup B meningococcal Vaccine
Phase 2

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 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 147
Study Start Date: September 2006
Study Completion Date: August 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
"rMenB "Routine vaccinations + Novartis rMenB vaccine 2, 4, 6, and 12 months (rMenB)
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 2
"rMenB + OMV" Routine vaccinations + Novartis rMenB vaccine + OMV NZ 2, 4, 6, and 12 months (rMenB+ OMV)
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 3
"Routine" Routine vaccinations + Novartis rMenB vaccine12 months (rMenB)
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 4
"Routine+OMV" Routine vaccinations + Novartis rMenB vaccine + OMV NZ 12 months (rMenB + OMV)
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.

  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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381615

Locations
United Kingdom
Gloucester, United Kingdom, GLI 3NN
London, United Kingdom, NW9 5EQ
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines - Information Services Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00381615     History of Changes
Other Study ID Numbers: V72P6
Study First Received: September 27, 2006
Last Updated: January 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Meningococcal disease
prevention
vaccination

ClinicalTrials.gov processed this record on April 17, 2014