Brief Title
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
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
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Secondary Outcome
Effect of Concomitant and Sequential Vaccination on hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
Condition
Meningococcal Meningitis
Intervention
Novartis Meningococcal ACWY Conjugate Vaccine
Study Arms / Comparison Groups
MenACWY + Tdap + HPV
Description: Subjects received MenACWY concomitantly with Tdap and HPV at study month 0 followed by two injections of HPV at month 2 and 6
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
1620
Start Date
July 2007
Completion Date
October 2008
Primary Completion Date
April 2008
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;
Gender
All
Ages
11 Years - 18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Novartis Vaccines and Diagnostics, ,
Location Countries
Costa Rica
Location Countries
Costa Rica
Administrative Informations
NCT ID
NCT00518180
Organization ID
V59P18
Responsible Party
Sponsor
Study Sponsor
Novartis Vaccines
Study Sponsor
Novartis Vaccines and Diagnostics, Study Director, Novartis
Verification Date
April 2016