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

• Conditions: ovartis Meningococcal ACWY conjugate vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis serogroups A, C, W and Y.; MedDRA version: 17.1Level: PTClassification code 10027280Term: Meningococcal sepsisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.1Level: PTClassification code 10027249Term: Meningitis meningococcalSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.1Level: LLTClassification code 10027276Term: Meningococcal meningitisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.1Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.1Level: LLTClassification code 10040081Term: Septicaemia meningococcalSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.1Level: LLTClassification code 10040048Term: Sepsis meningococcalSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-003504-79-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines & Diagnostics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-24
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 3539

Inclusion Criteria

Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1636
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1332
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Subjects with:
•A previous or suspected disease caused by N. meningitidis
•Previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
•Previous or suspected disease caused by N. meningitidis
•Any serious acute, chronic or progressive disease
•Pregnant or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified