Meningitis, Meningococcal Meningitis, Meningococcal Infections
Conditions
Keywords
Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine
Brief summary
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
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.
Interventions
BIOLOGICALMeningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular. 2 doses 3 months apart
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Solicited Injection-Site Reactions and Systemic Reactions Following Vaccination with Menactra® | Day 0 up to Day 30 post-vaccination | 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 |
| Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra® | Day 0 up to Day 30 post-vaccination | — |
Countries
South Korea
Outcome results
None listed