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

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

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