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

Meningococcal Meningitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474487
• Other study ID #: V59P17
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2007
• Last updated: April 1, 2014
• Start date: May 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2831
• Est. completion date: February 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Infections
• Meningococcal Meningitis

Intervention

Biological:
• Meningococcal ACWY Polysaccharide Vaccine
One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.
• 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.
• Meningococcal ACWY Conjugate Vaccine
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.
• 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.

Locations

Country	Name	City	State
Argentina	Buenos Aires, Argentina	Buenos Aires
Colombia	Cali, Colombia; Bogota, Colombia	Cali; Bogota

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Argentina,  Colombia, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes