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OpenTrials
Completed

NCT Number: NCT02699840

Observational Safety Study of Menactra® Administered 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.

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

No vaccine will be provided as part of this study

Other names: Menactra®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2016
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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