Clinical trial NCT02699840: Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Keywords: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Menactra®
Meningococcal Vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged 2 to 55 years will be enrolled after receipt of one dose of Menactra® during a routine health care visit.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine
timeFrame: Day 0 to Day 7 post-vaccination
Secondary outcomes:
measure: Number of participants reporting unsolicited adverse events and serious adverse events after a single dose of Menactra® vaccine
timeFrame: Day 0 to Day 28 post-vaccination
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
Study officials:
affiliation: Sanofi Pasteur Russia
name: Medical Director
role: STUDY_DIRECTOR
References: