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
  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:


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
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: 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 July 29, 2014