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
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: 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 October 29, 2014