Clinical trial NCT00262041: Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents
Official title: A Phase 2, Randomized, Single-blind, Controlled, Multicenter Study to Compare the Safety and Immune Response of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With the Safety and Immune Response of One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Adolescents 11 to 17 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prevention of Meningococcal Disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2005-12-06
Enrollment: 524
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.


Eligibility criteria: Inclusion Criteria:

* Healthy adolescents between and including 11-17 years of age, who provide written informed consent

Exclusion Criteria:

* Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

Primary outcomes:
measure: Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine
timeFrame: 1 month after vaccination
Secondary outcomes:
measure: hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine
timeFrame: 1 month after vaccination
measure: Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
timeFrame: 12 months after vaccination
measure: hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine
timeFrame: 12 months after vaccination
measure: Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination
timeFrame: Day 1 to Day 7
Other outcomes:
Locations:
city: Rochester
country: United States
state: Minnesota
city: Pittsburgh
country: United States
state: Pennsylvania
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Novartis
name: Novartis Vaccines
role: STUDY_DIRECTOR
References:
citation: Jackson LA, Jacobson RM, Reisinger KS, Anemona A, Danzig LE, Dull PM. A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents. Pediatr Infect Dis J. 2009 Feb;28(2):86-91. doi: 10.1097/INF.0b013e31818a0237.
citation: Jacobson RM, Jackson LA, Reisinger K, Izu A, Odrljin T, Dull PM. Antibody persistence and response to a booster dose of a quadrivalent conjugate vaccine for meningococcal disease in adolescents. Pediatr Infect Dis J. 2013 Apr;32(4):e170-7. doi: 10.1097/INF.0b013e318279ac38.