NCT02864927

Brief Summary

The purpose of the study is to perform the re-examination of Menactra® administered in the routine clinical settings in accordance with the Ministry of Food and Drug Safety regulation. Primary objective:

  • To describe the safety profile after 1 dose of Menactra® administered from 9 months to 55 years of age under standard health care practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,311

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2016

Typical duration for phase_4

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

July 21, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

2.9 years

First QC Date

August 5, 2016

Last Update Submit

April 21, 2022

Conditions

MeningitisMeningococcal MeningitisMeningococcal Infections

Keywords

MeningitisMeningococcal MeningitisMeningococcal InfectionsMenactra®Meningococcal Vaccine

Outcome Measures

Primary Outcomes (2)

  • Number of Participants Reporting Solicited Injection-Site Reactions and Systemic Reactions Following Vaccination with Menactra®

    Solicited injection-site reactions: Tenderness/Pain, Erythema, and Swelling. Solicited systemic reactions: infants and toddlers (9 to 23 months) Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite and Irritability; Subjects aged 2 to 55 years, Fever (temperature), Headache, Malaise, and Myalgia

    Day 0 up to Day 30 post-vaccination

  • Number of Participants Reporting Unsolicited Adverse Events Following Vaccination with Menactra®

    Day 0 up to Day 30 post-vaccination

Study Arms (2)

Menactra Group 1

EXPERIMENTAL

Participants aged 9 to 23 months will receive 2 doses of Menactra

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

Menactra Group 2

EXPERIMENTAL

Participants aged 2 to 55 years will receive 1 dose of Menactra

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

0.5 mL, Intramuscular. 2 doses 3 months apart

Also known as: Menactra®
Menactra Group 1

Eligibility Criteria

Age9 Months - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Informed consent form signed by the subject (for subjects from 19 to 55 years of age) or the parent(s) or other legal representative (for subjects from 9 months to 18 years of age)

You may not qualify if:

  • Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure
  • Subjects who already participated in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

  • Kim HS, Engel S, Neveu D, Thollot Y, Oster P, Yang K. Post-Marketing Surveillance Observational Study of Quadrivalent Meningococcal Diphtheria Toxoid Conjugate Vaccine (MenACWY-DT, MCV4/Menactra(R)) in the Republic of Korea, 2014-2019. Infect Dis Ther. 2021 Mar;10(1):399-409. doi: 10.1007/s40121-020-00393-4. Epub 2021 Jan 13.

    PMID: 33439463DERIVED

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

  • Clinical Sciences & Operations

    Sanofi Pasteur, a Sanofi Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 12, 2016

Study Start

July 21, 2016

Primary Completion

June 12, 2019

Study Completion

June 12, 2019

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

KR(1)