Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Meningococcal Disease

Treatments

Biological: MenACWY-CRM (Menveo)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01766206

V59_62 (Other Identifier)

205341

Details and patient eligibility

About

A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.

Enrollment

3,948 patients

Sex

All

Ages

2 months to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Individuals eligible for enrolment in this study are those:

male and female subjects from 2 months to 55 years of the age at the time of Visit 1 (including all 55 years old subjects, up to one day before their 56th year birthday), who are scheduled to receive vaccination with MenACWY-CRM conjugate vaccine, according to the local prescribing information and routine clinical practice;
to whom the nature of the study has been described and the subject or subject's parent/legal representative has provided written informed consent;
whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the Diary Card);
who are in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator.

Exclusion criteria

Contraindication, special warnings and/or precautions, as evaluated by the investigators, reported in the MenACWY-CRM conjugate vaccine Korean prescribing information. In particular, should not be included in the study a subject who has ever had:

an allergic reaction to the active substances or any of the other ingredients of the study vaccine; an allergic reaction to diphtheria toxoid;
an illness with high fever; however, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination. Special care should be taken for subjects having haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).