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

Phase 3

Completed

• Conditions: Meningococcal Meningitis; Meningococcal Infections
• Interventions: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: MenACWY CRM (19 to 55 years); Biological: Meningococcal ACWY Polysaccharide Vaccine; Biological: Novartis MenACWY Vaccine (56 to 65 Years)

• 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

Arm && Interventions

Group	Intervention	Description
Licensed Conjugate Vaccine	Meningococcal ACWY Conjugate Vaccine	Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine
Novartis MenACWY Vaccine (19 to 55 Years)	MenACWY CRM (19 to 55 years)	Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years
Licensed polysaccharide vaccine	Meningococcal ACWY Polysaccharide Vaccine	Licensed meningococcal ACWY polysaccharide vaccine
Novartis MenACWY Vaccine (56 to 65 Years)	Novartis MenACWY Vaccine (56 to 65 Years)	Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years

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)

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

Buenos Aires, Argentina; 🇦🇷 Buenos Aires, Argentina