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

A Phase 3, Multi-center Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adults and Compare to the Safety and Immune Response of a Licensed Conjugate Meningococcal ACWY Vaccine in Subjects Aged 19-55 Years of Age and to a Licensed Polysaccharide Vaccine in Subjects Aged 56-65 Years of Age.

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 2831
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1406DGI
    • Buenos Aires, Argentina
• Colombia
  • Cali; Bogota, Colombia
    • Cali, Colombia; Bogota, Colombia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Novartis MenACWY Vaccine (19 to 55 Years); Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years	Biological: MenACWY CRM (19 to 55 years); One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.
Active Comparator: Licensed polysaccharide vaccine; Licensed meningococcal ACWY polysaccharide vaccine	Biological: Meningococcal ACWY Polysaccharide Vaccine; One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.
Active Comparator: Licensed Conjugate Vaccine; Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine	Biological: Meningococcal ACWY Conjugate Vaccine; One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.
Experimental: Novartis MenACWY Vaccine (56 to 65 Years); Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years	Biological: Novartis MenACWY Vaccine (56 to 65 Years); One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years	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.	Days 1 to 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population	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.	1 month postvaccination
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population	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.	1 month postvaccination
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population	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.	1 month postvaccination
Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population	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.	1 month postvaccination
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years	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).	Days 1 to 7
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years	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).	Days 1 to 7

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Publications and helpful links

General Publications

• Stamboulian D, Lopardo G, Lopez P, Cortes-Barbosa C, Valencia A, Bedell L, Karsten A, Dull PM. Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. Int J Infect Dis. 2010 Oct;14(10):e868-75. doi: 10.1016/j.ijid.2010.03.017. Epub 2010 Jul 22.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: May 16, 2007
• First Submitted That Met QC Criteria: May 16, 2007
• First Posted (Estimate): May 17, 2007

Study Record Updates

• Last Update Posted (Estimate): April 21, 2014
• Last Update Submitted That Met QC Criteria: April 1, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: vaccine; adolescents; meningitis; adults; Meningococcal
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Neisseriaceae Infections; Meningitis, Meningococcal; Meningitis; Meningococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: V59P17