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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Meningococcal ACWY Polysaccharide Vaccine

MenACWY CRM (19 to 55 years)

Meningococcal ACWY Conjugate Vaccine

Novartis MenACWY Vaccine (56 to 65 Years)

About this trial

This is an interventional prevention trial for Meningococcal Meningitis focused on measuring Meningococcal, meningitis, vaccine, adolescents, adults

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Buenos Aires, Argentina
Cali, Colombia; Bogota, Colombia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Novartis MenACWY Vaccine (19 to 55 Years)

Licensed polysaccharide vaccine

Licensed Conjugate Vaccine

Novartis MenACWY Vaccine (56 to 65 Years)

Arm Description

Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years

Licensed meningococcal ACWY polysaccharide vaccine

Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine

Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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).

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).

Full Information

NCT ID

NCT00474487

First Posted

May 16, 2007

Last Updated

April 1, 2014

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT00474487

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningococcal Meningitis, Meningococcal Infections

Keywords

Meningococcal, meningitis, vaccine, adolescents, adults

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2831 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Novartis MenACWY Vaccine (19 to 55 Years)

Arm Type

Experimental

Arm Description

Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years

Arm Title

Licensed polysaccharide vaccine

Arm Type

Active Comparator

Arm Description

Licensed meningococcal ACWY polysaccharide vaccine

Arm Title

Licensed Conjugate Vaccine

Arm Type

Active Comparator

Arm Description

Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine

Arm Title

Novartis MenACWY Vaccine (56 to 65 Years)

Arm Type

Experimental

Arm Description

Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years

Intervention Type

Biological

Intervention Name(s)

Meningococcal ACWY Polysaccharide Vaccine

Intervention Description

One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.

Intervention Type

Biological

Intervention Name(s)

MenACWY CRM (19 to 55 years)

Intervention Description

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.

Intervention Type

Biological

Intervention Name(s)

Meningococcal ACWY Conjugate Vaccine

Intervention Description

One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.

Intervention Type

Biological

Intervention Name(s)

Novartis MenACWY Vaccine (56 to 65 Years)

Intervention Description

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.

Primary Outcome Measure Information:

Title

Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years

Description

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.

Time Frame

Days 1 to 7

Secondary Outcome Measure Information:

Title

Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population

Description

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.

Time Frame

1 month postvaccination

Title

Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population

Description

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.

Time Frame

1 month postvaccination

Title

Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population

Description

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.

Time Frame

1 month postvaccination

Title

Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population

Description

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.

Time Frame

1 month postvaccination

Title

Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years

Description

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).

Time Frame

Days 1 to 7

Title

Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years

Description

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).

Time Frame

Days 1 to 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines and Diagnostics

Organizational Affiliation

Novartis

Official's Role

Study Director

Facility Information:

Facility Name

Buenos Aires, Argentina

City

Buenos Aires

ZIP/Postal Code

C1406DGI

Country

Argentina

Facility Name

Cali, Colombia; Bogota, Colombia

City

Cali; Bogota

Country

Colombia

12. IPD Sharing Statement

Citations:

PubMed Identifier

20655261

Citation

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.

Results Reference

result

Meningococcal Meningitis, Meningococcal Infections

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial