Clinical trial NCT00474487: A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Meningitis
Meningococcal Infections
Keywords: Meningococcal
meningitis
vaccine
adolescents
adults
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 2831
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years
timeFrame: Days 1 to 7
Secondary outcomes:
measure: Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population
timeFrame: 1 month postvaccination
measure: Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population
timeFrame: 1 month postvaccination
measure: Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population
timeFrame: 1 month postvaccination
measure: Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population
timeFrame: 1 month postvaccination
measure: Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years
timeFrame: Days 1 to 7
measure: Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years
timeFrame: Days 1 to 7
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Buenos Aires, Argentina
city: Cali; Bogota
country: Colombia
facility: Cali, Colombia; Bogota, Colombia
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_DIRECTOR
References:
citation: 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 Latin America. Int J Infect Dis. 2010 Oct;14(10):e868-75. doi: 10.1016/j.ijid.2010.03.017. Epub 2010 Jul 22.