Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the R… (NCT02699840) | Clinical Trial Compass
CompletedNot Applicable
Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation
Russia100 participantsStarted 2016-02
Plain-language 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.
Who can participate
Age range2 Years – 55 Years
SexALL
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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.
What they're measuring
1
Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine