Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation

Completed

• Conditions: Meningitis; Meningococcal Meningitis; Meningococcal Infections
• Interventions: Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

• Registration Number: NCT02699840
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-04
• Primary Completion: 2016-07-25
• Study Completion: 2016-07-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Menactra Study Group 2	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Participant aged 12 through 17 years at vaccination
Menactra Study Group 1	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Participant aged 2 through 11 years at vaccination
Menactra Study Group 3	Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Participant aged 18 through 55 years at vaccination

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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