A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

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

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

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;