Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults - Full Text View

Sponsor:	Novartis Vaccines
Information provided by (Responsible Party):	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00560313

Purpose

This study is aimed to evaluate safety, tolerability and immunogenicity of three doses of Novartis 4CMenB and of one dose of Novartis Meningococcal ACWY vaccine when administered to healthy at-risk adults.

Condition	Intervention	Phase
Meningococcal Disease	Biological: Men ACWY CRM Biological: 4CMenB	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase 2, Multi-Center, Open-label Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2, 6-Month Schedule and of a Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy At-risk Adults 18-50 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Meningococcal Infections

Drug Information available for: Lactitol

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]
Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.
Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; %≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:
- prior to the first vaccination
- 30 days following the first, second, prior to the third and 30 days after the third vaccination
Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]
Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.
Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: No ]
Percentage of participants with serum bactericidal activity (SBA) of the Meningococcal ACWY vaccine at one month after vaccination against A, C, W-135 and Y strains. Bactericidal activity (% ≥1:4, i.e., percentage of subjects with BCA titer ≥ 1:4; %≥ 1:8, i.e. percentage of subjects with BCA titer ≥ 1:8) against a panel of genetically distinct meningococcal B strains:
- prior to the first vaccination
- 30 days following the first, second, prior to the third and 30 days after the third vaccination
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination [ Time Frame: one month after vaccination ] [ Designated as safety issue: Yes ]
the number of subjects who reported solicited reactions after the administration of the Meningococcal B vaccine at a 0, 2, 6-month schedule and the administration of the Meningococcal A, C, W, and Y vaccine at month 7.

Enrollment:	54
Study Start Date:	July 2007
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 4CMenB	Biological: 4CMenB All subjects will receive the study vaccine following a 0,2,6 vaccination schedule. Pre-filled syringe, administered by intramuscular injection into the deltoid area of the non dominant arm.
Experimental: MenACWY CRM	Biological: Men ACWY CRM a single dose of a 0.5 mL injectable solution

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy adults,18 through 50 years of age, who are or may be routinely exposed to N. meningitidis cultures

Exclusion Criteria:

previous ascertained or suspected disease caused by N. meningitidis;
pregnancy or breastfeeding;
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: NCT00560313

Locations

Italy
Azienda USL 7 of Siena
Siena, Italy, 53100

Sponsors and Collaborators

Novartis Vaccines

Investigators

Study Director:

Novartis Vaccines

More Information

Publications:

Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol. 2011 Mar;18(3):483-6. Epub 2010 Dec 22.

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00560313 History of Changes
Other Study ID Numbers:	V72P4, 2007-001563-29
Study First Received:	November 16, 2007
Results First Received:	June 6, 2011
Last Updated:	December 8, 2011
Health Authority:	Germany: Paul-Ehrlich-Institut

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