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

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ClinicalTrials.gov Identifier: NCT02699840
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( 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.

Condition or disease Intervention/treatment
Meningitis Meningococcal Meningitis Meningococcal Infections Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

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
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : February 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : October 2016


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 Name: 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 Name: 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 Name: Menactra®




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699840


Locations
Russian Federation
Moscow, Russian Federation
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Russia

Additional Information:
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02699840     History of Changes
Other Study ID Numbers: MTA92
U1111-1174-4339 ( Other Identifier: WHO )
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (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".

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Meningitis
Meningococcal Infections
Menactra®
Meningococcal Vaccine

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs