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

Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560313
• Other study ID #: V72P4
• Secondary ID: 2007-001563-29
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2007
• Last updated: December 8, 2011
• Start date: July 2007
• Est. completion date: November 2009

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• Men ACWY CRM
a single dose of a 0.5 mL injectable solution
• 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.

Locations

Country	Name	City	State
Italy	Azienda USL 7 of Siena	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 incr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination	Geometric mean titers(GMT) and the respective confidence intervals measured after each vaccination against the three different meningococcal strains.	one month after vaccination	No
Primary	Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination	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	one month after vaccination	No
Primary	Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination	Geometric mean titer (GMT) of the Meningococcal ACWY Vaccine at One Month After the Immunization against the A, C, W-135 and Y strains.	one month after vaccination	No
Primary	Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination	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	one month after vaccination	No
Primary	Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination	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.	one month after vaccination	Yes