Meningitis, Meningococcal Meningitis, Meningococcal Infections
Conditions
Keywords
Meningitis, Meningococcal Meningitis, Meningococcal Infections, Menactra®, Meningococcal Vaccine
Brief summary
The aim of this study is to generate local data on the safety of Menactra® in individuals 2 to 55 years of age in the Russian Federation. Primary Objective: * To describe the safety profile after 1 dose of Menactra® administered in individuals 2-55 years of age under standard health care practices.
Detailed description
Participants will be enrolled after receipt of one dose of Menactra® during a routine health care visit. They will be monitored for safety throughout the study.
Interventions
BIOLOGICALMeningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be provided as part of this study
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 2 through 55 years on the day of enrollment 2 through 55 years means from the day of the 2nd birthday to the day before the 56th birthday * For adults (18-55 years old) Informed consent form has been signed and dated by the participant. * For minors: Informed consent form has been signed and dated by the parent. In addition, in accordance with the Institution Ethics Committee/Institution Review Board requirements and as appropriate for the age of the participant: * participants aged 14 to 17 years are required to sign and date the informed consent form, * participants aged 10 to 13 years are required to sign and date the assent form, * for participants under 10 years, consent may be asked orally according to participant's age and ability for understanding * Receipt of one dose of Menactra® on the day of inclusion and prior to enrollment into the study, in routine practice according to the approved local product insert.
Exclusion criteria
* Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine | Day 0 to Day 7 post-vaccination | Solicited injection site: Pain, Erythema and Swelling, Solicited systemic: Fever (Temperature), Headache, Malaise and Myalgia |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants reporting unsolicited adverse events and serious adverse events after a single dose of Menactra® vaccine | Day 0 to Day 28 post-vaccination |
Countries
Russia
Outcome results
None listed