NCT02699840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2016

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

March 1, 2016

Last Update Submit

April 21, 2022

Conditions

MeningitisMeningococcal MeningitisMeningococcal Infections

Keywords

MeningitisMeningococcal MeningitisMeningococcal InfectionsMenactra®Meningococcal Vaccine

Outcome Measures

Primary Outcomes (1)

  • Number of participants reporting solicited injection site and systemic reactions after a single dose of Menactra® vaccine

    Solicited injection site: Pain, Erythema and Swelling, Solicited systemic: Fever (Temperature), Headache, Malaise and Myalgia

    Day 0 to Day 7 post-vaccination

Secondary Outcomes (1)

  • 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

Study Arms (3)

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

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

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

Interventions

Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineBIOLOGICAL

No vaccine will be provided as part of this study

Also known as: Menactra®
Menactra Study Group 1

Eligibility Criteria

Age2 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Moscow, Russia

Location

Related Links

MeSH Terms

Conditions

MeningitisMeningitis, MeningococcalMeningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System DiseasesMeningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Medical Director

    Sanofi Pasteur Russia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 4, 2016

Study Start

February 1, 2016

Primary Completion

July 25, 2016

Study Completion

July 25, 2016

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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

Locations

RU(1)