Meningitis Clinical Trial
Official title:
Observational Study of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Menactra® Administered in Individuals 2 Through 55 Years Old Under Standard Health Care Practice in the Russian Federation
| Verified date | April 2022 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | July 25, 2016 |
| Est. primary completion date | July 25, 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 2 Years to 55 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi Pasteur, a Sanofi Company |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine | Solicited injection site: Pain, Erythema and Swelling, Solicited systemic: Fever (Temperature), Headache, Malaise and Myalgia | Day 0 to Day 7 post-vaccination | |
| Secondary | 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 |
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