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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699840
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date March 1, 2016
First Posted Date March 4, 2016
Last Update Posted Date February 15, 2019
Study Start Date February 2016
Actual Primary Completion Date July 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02699840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 1, 2016)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Meningitis
  • Meningococcal Meningitis
  • Meningococcal Infections
Intervention 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 Name: Menactra®
Study Groups/Cohorts
  • Menactra Study Group 1
    Participant aged 2 through 11 years at vaccination
    Intervention: 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
    Intervention: 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
    Intervention: Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 1, 2016)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date July 25, 2016
Actual Primary Completion Date July 25, 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT02699840
Other Study ID Numbers MTA92
U1111-1174-4339 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi".
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor Sanofi Pasteur, a Sanofi Company
Collaborators Not Provided
Investigators
Study Director: Medical Director Sanofi Pasteur Russia
PRS Account Sanofi
Verification Date February 2019