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

Phase 2

Completed

• Conditions: Meningococcal Disease
• Interventions: Biological: Men ACWY CRM; Biological: 4CMenB

• Registration Number: NCT00560313
• Lead Sponsor: Novartis Vaccines

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2011-06-06
• Results First Submitted QC: 2011-06-06
• Results First Posted: 2011-07-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Healthy adults,18 through 50 years of age, who were or might 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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MenACWY CRM	Men ACWY CRM	-
4CMenB	4CMenB	-

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination.	One month after vaccinations	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.	One month after vaccinations	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.	One month after vaccinations	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	One month after vaccinations	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.	One month after vaccinations	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.

Trial Locations

Locations (1)

Azienda USL 7 of Siena; 🇮🇹 Siena, Italy