Study to Evaluate the Safety and Immunogenicity of Travel Vaccines when Administered Concomitantly with Meningococcal ACWY Conjugate Vaccine in Healthy Adults

• Conditions: Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults; MedDRA version: 14.0Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-000475-14-DE
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-08
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Inclusion Criteria: Female and male subjects eligible to be enrolled in this study
must be:
? available for all study visits,
? able to give written informed consent,
? between 18 and 60 years of age, and
? generally in good health.
Subjects with previous vaccination with one or more antigens related to any of the
study vaccines, determined by history (interview of the subject) and/or by review of
his or her vaccination card, will be eligible to participate in the study if more than 5
years have elapsed since vaccination.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Serious, acute, or chronic illnesses are reasons for exclusion.
Women will be required to have a negative urine pregnancy test before being
enrolled in the study.
The full list of inclusion and exclusion criteria is included in protocol section 4.0.
Personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any
flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow
fever, dengue fever, West e virus infection) is considered exclusion criteria.

Study & Design

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