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Safety, Tolerability and Immunogenicity of Two Different Formulations of MenB Vaccine, When Administered to Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00433914
First received: February 9, 2007
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  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
Meningococcal Disease
 Biological: Serogroup B meningococcal Vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase 2, Single Blind, Single Center, 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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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: No ]
  • Safety and tolerability of the two vaccines [ Time Frame: throughout the clinical study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity as measured by serum bactericidal activity of the two vaccines [ Time Frame: at one month after 2 vaccine administration ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2007
Study Completion Date: June 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I
Novartis rMenB Vaccine without OMV
 Biological: Serogroup B meningococcal Vaccine
In this study healthy infants aged 6 to 8 months at time of enrollment were randomized in a 1:1 ratio to receive 3 doses of Novartis rMenB Vaccine ±OMV at the time of enrollment (6 to 8 months of age), two months later and at 12 months of age. Novartis Meningococcal Recombinant Vaccine +/- OMV is supplied in a pre-filled syringe, 0.5 mL dose.
Experimental: Group II
Novartis rMenB Vaccine with OMV
 Biological: Serogroup B meningococcal Vaccine
In this study healthy infants aged 6 to 8 months at time of enrollment were randomized in a 1:1 ratio to receive 3 doses of Novartis rMenB Vaccine ±OMV at the time of enrollment (6 to 8 months of age), two months later and 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:   6 Months to 8 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy 6-8 months old infants

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: NCT00433914

Locations
United Kingdom
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines (formerly Chiron Vaccines) Novartis 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: NCT00433914     History of Changes
Other Study ID Numbers: V72P9, Eudract Number: 2006-005589-38
Study First Received: February 9, 2007
Last Updated: January 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Meningococcal disease, prevention, vaccination

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 21, 2013