Clinical trial NCT00518180: A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents
Official title: A Phase 3, Single-Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY Vaccine Administered Either Alone or Concomitantly With a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine in Healthy Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Meningitis
Human Papillomavirus Infection
Pertussis
Tetanus
Keywords: Meningococcal
meningitis
vaccine
adolescents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 1620
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
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 the Novartis Meningococcal ACWY conjugate vaccine when administered with Tdap and HPV vaccinations to healthy adolescents


Eligibility criteria: Inclusion Criteria:

* Healthy adolescents 11-18 years of age
* virgins (both male and female) with no intention of becoming sexually active during the study period
* who have been properly vaccinated against diphtheria, tetanus, pertussis

Exclusion Criteria:

* who had a previous confirmed or suspected disease caused by N. meningitidis;
* who have previously been immunized with a meningococcal vaccine
* who have received prior human papillomavirus (HPV) vaccine;
* who have any serious acute, chronic or progressive disease
* who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
* who have a known or suspected impairment/alteration of immune function, either congenital or acquired
* who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
* who have Down's syndrome or other known cytogenic disorders;

Primary outcomes:
measure: Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
timeFrame: 1 month post MenACWY vaccination
measure: Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
timeFrame: 1 month post Tdap vaccination
measure: Geometric Mean Concentrations (GMC) of Antipertussis Toxin (Anti-PT), Antifilamentous Hemagglutinin (Anti-FHA), and Antipertactin (Anti-PRN)
timeFrame: 1 month post Tdap vaccination
Secondary outcomes:
measure: Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
timeFrame: 1 month post MenACWY vaccination
measure: Percentage of Subjects With Anti-HPV Seroconversion
timeFrame: 1 month post third HPV vaccination
measure: Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay
timeFrame: 1 month post third HPV vaccination
measure: Percentage of Subjects With hSBA ≥ 1:8, hSBA Titer ≥ 1:4, for A, C, W, and Y Serogroups
timeFrame: 1 month post MenACWY vaccination
measure: The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus
timeFrame: 1 month post Tdap vaccination
measure: Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
timeFrame: 1 month post Tdap vaccination
measure: Geometric Mean Titers (GMT) of Pertussis Antigens
timeFrame: 1 month post Tdap vaccination
measure: Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
timeFrame: 1 month post Tdap vaccination
measure: Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.
timeFrame: Days 1 to 7
measure: Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination
timeFrame: Days 1 to 7
Other outcomes:
Locations:
city: San Jose
country: Costa Rica
facility: San Jose, Costa Rica
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_DIRECTOR
References:
citation: Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, Porras W, Alvarado O, Aguilar L, Abdelnour A, Grunwald U, Bedell L, Anemona A, Dull PM. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010 Apr 19;28(18):3171-9. doi: 10.1016/j.vaccine.2010.02.045. Epub 2010 Feb 26.