Postmarketing Surveillance Study for Use of Menactra® in the Republic of Korea

Study Overview
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Brief Summary
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The purpose of the study is to perform the re-examination of Menactra® administered in the routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation. Primary objective: To describe the safety profile after 1 dose of Menactra® administered from 9 months to 55 years of age under standard health care practice.

Detailed Description
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Subjects aged 9 months through 55 years and who are given study vaccine during routine health-care visits will be enrolled in the study. They will be followed-up for up to Day 42 following vaccination. No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.

Official Title
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Postmarketing Surveillance Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in the Republic of Korea

Conditions
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Meningitis, Meningococcal Meningitis, Meningococcal Infections

Intervention / Treatment
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* Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
* Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent form signed by the subject (for subjects from 19 to 55 years of age) or the parent(s) or other legal representative (for subjects from 9 months to 18 years of age) Receipt of one dose of Menactra® (on the day of inclusion) according to approved local product insert paper . Exclusion Criteria: Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure Subjects who already participated in this study.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menactra Group 1<br>Participants aged 9 to 23 months will receive 2 doses of Menactra | Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine<br>* 0.5 mL, Intramuscular. 2 doses 3 months apart<br>* Other names: Menactra®;|
| Experimental: Menactra Group 2<br>Participants aged 2 to 55 years will receive 1 dose of Menactra | Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Solicited Injection-Site Reactions and Systemic Reactions Following Vaccination with Menactra® | Solicited injection-site reactions: Tenderness/Pain, Erythema, and Swelling. Solicited systemic reactions: infants and toddlers (9 to 23 months) Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite and Irritability; Subjects aged 2 to 55 years, Fever (temperature), Headache, Malaise, and Myalgia | Day 0 up to Day 30 post-vaccination | 
| Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra® |  | Day 0 up to Day 30 post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine