Clinical trial NCT00450437: A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Infections
Meningococcal Meningitis
Keywords: Meningococcal
meningitis
vaccine
adolescents
adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-03-22
Enrollment: 3539
Sex: ALL
Minimum age (years): 11
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
timeFrame: 28 days after vaccination
measure: Percentage of Seroresponders, Ages 11 to 18 Years
timeFrame: 28 days after vaccination
measure: Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
timeFrame: 6 days after vaccination
measure: Percentage of Seroresponders, Ages 19 to 55 Years
timeFrame: 28 days after vaccination
Secondary outcomes:
measure: 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
timeFrame: 28 days after vaccination
measure: Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
timeFrame: 28 days after vaccination
measure: Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
timeFrame: 28 days after vaccination
measure: Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
timeFrame: Days 1 to 7
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Fremont
country: United States
state: California
city: Fresno
country: United States
state: California
city: Hayward
country: United States
state: California
city: Oakland
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Jose
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Bardstown
country: United States
state: Kentucky
city: Annapolis
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Frederick
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Fall River
country: United States
state: Massachusetts
city: Lebanon
country: United States
state: New Hampshire
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: South Euclid
country: United States
state: Ohio
city: Carnegie
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: Pennsylvania
city: Grove City
country: United States
state: Pennsylvania
city: Harleyville
country: United States
state: Pennsylvania
city: Jefferson Borough
country: United States
state: Pennsylvania
city: Latrobe
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Uniontown
country: United States
state: Pennsylvania
city: Upper St. Clair
country: United States
state: Pennsylvania
city: Washington
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Galveston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_DIRECTOR
References:
citation: 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. Clin Infect Dis. 2009 Jul 1;49(1):e1-10. doi: 10.1086/599117.
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;16(12):1810-5. doi: 10.1128/CVI.00207-09. Epub 2009 Oct 7.