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

Sponsor:	Novartis Vaccines
Information provided by (Responsible Party):	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00433914

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 II

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:

MedlinePlus related topics: Meningococcal Infections

Drug Information available for: Meningococcal Vaccines Lactitol

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

Criteria

Inclusion Criteria:

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

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 February 12, 2012