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.
- Conditions
- Healthy volunteers (Prevention of invasive meningococcal disease)Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2017-000166-30-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 3960
1. Male and female subjects from 2 months to 55 years of the age at the time of vaccination (including all 55 years of age 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;
2. To whom the nature of the study has been described and the subject or subject’s parent/legal representative has provided written informed consent;
3. Whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the Diary Card);
4. Who are in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 3960
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Contraindication, special warnings and/or precautions, as evaluated by the investigators, reported in the MenACWY-CRM conjugate vaccine Korean prescribing information.
2. Infants who were already enrolled in this trial at another study site for previous vaccination.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method