Moscow, Russia
NCT Number: NCT02699840
Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation
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.
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Conditions
Age range
2 year–55 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
BiologicalNo vaccine will be provided as part of this study
Other names: Menactra®
Primary outcomes
-
Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine
Time frame: Day 0 to Day 7 post-vaccination
Solicited injection site: Pain, Erythema and Swelling, Solicited systemic: Fever (Temperature), Headache, Malaise and Myalgia
Secondary outcomes
-
Number of participants reporting unsolicited adverse events and serious adverse events after a single dose of Menactra® vaccine
Time frame: Day 0 to Day 28 post-vaccination
Sponsors and collaborators
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Industry
Registry information
Official study 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
Important dates
- Study start
- 2016
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Mar 4, 2016
- Registry last updated
- Apr 25, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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