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

Purpose

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

Condition	Intervention	Phase
Meningococcal Meningitis Meningococcal Infections	Biological: Meningococcal ACWY Polysaccharide Vaccine Biological: MenACWY CRM (19 to 55 years) Biological: Meningococcal ACWY Conjugate Vaccine Biological: Novartis MenACWY Vaccine (56 to 65 Years)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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.

Resource links provided by NLM:

MedlinePlus related topics: Meningitis Meningococcal Infections

Drug Information available for: Lactitol

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 month postvaccination ] [ Designated as safety issue: No ]
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 [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Days 1 to 7 ] [ Designated as safety issue: Yes ]
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).

Enrollment:	2831
Study Start Date:	May 2007
Study Completion Date:	February 2008
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474487

Locations

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

Sponsors and Collaborators

Novartis Vaccines

Investigators

Study Director:

Novartis Vaccines and Diagnostics

Novartis

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00474487 History of Changes
Other Study ID Numbers:	V59P17
Study First Received:	May 16, 2007
Results First Received:	March 19, 2010
Last Updated:	December 9, 2011
Health Authority:	United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Novartis:

Meningococcal
meningitis
vaccine
adolescents
adults

Additional relevant MeSH terms:

Lactitol
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial

Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013