A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

Meningococcal Meningitis Clinical Trial

Official title:

A Phase 3, Multi-center Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450437
• Other study ID #: V59P13
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2007
• Last updated: January 15, 2015
• Start date: March 2007
• Est. completion date: January 2008

Study information

• Verified date: January 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3539
• Est. completion date: January 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent

Exclusion Criteria:

• Subjects with a previous or suspected disease caused by N. meningitidis

• previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)

• previous or suspected disease caused by N. meningitidis

• Any serious acute, chronic or progressive disease

• 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:
• MenACWY CRM
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
• Meningococcal ACWY Conjugate vaccine
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

United States, 

References & Publications (2)

Jackson LA, Baxter R, Reisinger K, Karsten A, Shah J, Bedell L, Dull PM; V59P13 Study Group. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Cli — View Citation

Reisinger KS, Baxter R, Block SL, Shah J, Bedell L, Dull PM. Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra. Clin Vaccine Immunol. 2009 Dec;1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years	The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)	28 days after vaccination	No
Primary	Percentage of Seroresponders, Ages 11 to 18 Years	Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).; Seroresponse to MenACWY: 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.	28 days after vaccination	No
Primary	Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years	Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.; Note: severe adverse events: unable to perform normal daily activity	6 days after vaccination	Yes
Primary	Percentage of Seroresponders, Ages 19 to 55 Years	Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age).; Seroresponse to MenACWY: 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.	28 days after vaccination	No
Secondary	Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer = 1:8, and = 1:4, Ages 11 to 18 Years	The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer = 1:4 and = 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).; Seroresponse to MenACWY: 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.	28 days after vaccination	No
Secondary	Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer = 1:8, and hSBA Titer = 1:4, Ages 11 to 55 Years	Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).; Seroresponse to MenACWY: 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.	28 days after vaccination	No
Secondary	Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years	Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).	28 days after vaccination	No
Secondary	Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years	Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).	Days 1 to 7	Yes