Postmarketing Surveillance Study for Use of Menactra® in the Republic of Korea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-21

Study Completion Date

2019-06-12

Brief Summary

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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.

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Detailed Description

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Subjects aged 9 months through 55 years and who are given study vaccine during routine health-care visits will be enrolled in the study.

They will be followed-up for up to Day 42 following vaccination.

No study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.

Conditions

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Meningitis Meningococcal Meningitis Meningococcal Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Menactra Group 1

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular. 2 doses 3 months apart

Menactra Group 2

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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

0.5 mL, Intramuscular. 2 doses 3 months apart

Intervention Type BIOLOGICAL

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

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Menactra® Menactra®

Eligibility Criteria

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Inclusion Criteria

* 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)
* Receipt of one dose of Menactra® (on the day of inclusion) according to approved local product insert paper .

Exclusion Criteria

* 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.

Minimum Eligible Age

9 Months

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes