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

April 21, 2022 updated by: Sanofi Pasteur, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Menactra Study Group 1
Participant aged 2 through 11 years at vaccination
Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be provided as part of this study
Other Names:
  • Menactra®
Menactra Study Group 2
Participant aged 12 through 17 years at vaccination
Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be provided as part of this study
Other Names:
  • Menactra®
Menactra Study Group 3
Participant aged 18 through 55 years at vaccination
Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be provided as part of this study
Other Names:
  • Menactra®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 to Day 7 post-vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 0 to Day 28 post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Investigators

  • Study Director: Medical Director, Sanofi Pasteur Russia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 25, 2016

Study Completion (Actual)

July 25, 2016

Study Registration Dates

First Submitted

March 1, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTA92
  • U1111-1174-4339 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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