A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

Phase 3

Completed

• Conditions: Meningococcal Meningitis; Meningococcal Infections

• Registration Number: NCT00474487
• Lead Sponsor: Novartis Vaccines

Brief Summary

This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-16
• Study First Posted: 2007-05-17
• Primary Completion: 2007-08
• Study Completion: 2008-02
• Disposition First Submitted: 2009-08-03
• Disposition First Submitted QC: 2009-08-03
• Disposition First Posted: 2009-08-10
• Results First Submitted: 2010-03-19
• Results First Submitted QC: 2010-07-05
• Results First Posted: 2010-08-04
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2831

Inclusion Criteria

• individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent
• individuals who are available for all visits and telephone calls scheduled for the study;
• individuals who are in good health

Exclusion Criteria

• individuals with a previous or suspected disease caused by N. meningitidis
• individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
• individuals with previous or suspected disease caused by N. meningitidis
• individuals with any serious acute, chronic or progressive disease
• individuals who are pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years	Days 1 to 7	Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population	1 month postvaccination	Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years).; Seroresponse: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population	1 month postvaccination	Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age.
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years	Days 1 to 7	Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years).
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years	Days 1 to 7	Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years).
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population	1 month postvaccination	Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years).; Seroresponse: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population	1 month postvaccination	Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age.

Trial Locations

Locations (2)

Buenos Aires, Argentina; 🇦🇷 Buenos Aires, Argentina

Cali, Colombia; Bogota, Colombia; 🇨🇴 Cali; Bogota, Colombia