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Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea

Primary Purpose

Meningococcal Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MenACWY-CRM (Menveo)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring conjugate vaccine, phase IV clinical trial, Neisseria meningitidis

Eligibility Criteria

2 Months - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Individuals eligible for enrolment in this study are those:

  1. male and female subjects from 2 months to 55 years of the age at the time of Visit 1 (including all 55 years old subjects, up to one day before their 56th year birthday), who are scheduled to receive vaccination with MenACWY-CRM conjugate vaccine, according to the local prescribing information and routine clinical practice;
  2. to whom the nature of the study has been described and the subject or subject's parent/legal representative has provided written informed consent;
  3. whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the Diary Card);
  4. who are in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator.

Exclusion Criteria:

1. Contraindication, special warnings and/or precautions, as evaluated by the investigators, reported in the MenACWY-CRM conjugate vaccine Korean prescribing information. In particular, should not be included in the study a subject who has ever had:

  • an allergic reaction to the active substances or any of the other ingredients of the study vaccine; an allergic reaction to diphtheria toxoid;
  • an illness with high fever; however, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination. Special care should be taken for subjects having haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MenACWY-CRM Group

Arm Description

Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.

Outcomes

Primary Outcome Measures

Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. All unsolicited AEs reported from day 1 to day 7 post vaccination were assessed. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Number of Subjects Reporting Medically Attended AEs (MAAEs)
MAAEs are defined as events that require a physician's visit or an emergency room visit. All reported MAAEs from day 1 to day 29 were assessed. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Number of Subjects Reporting Serious AEs (SAEs)
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe, requires or prolongs subject's hospitalization, results in persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions), results in a congenital anomaly/birth defect, is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.

Secondary Outcome Measures

Full Information

First Posted
January 8, 2013
Last Updated
August 22, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01766206
Brief Title
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea
Official Title
A Multicenter Post Marketing Surveillance Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ACWY Conjugate Vaccine(MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects From 2 Months to 55 Years of Age in the Republic of South Korea.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 15, 2013 (Actual)
Primary Completion Date
January 22, 2018 (Actual)
Study Completion Date
January 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease
Keywords
conjugate vaccine, phase IV clinical trial, Neisseria meningitidis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3948 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MenACWY-CRM Group
Arm Type
Experimental
Arm Description
Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM (Menveo)
Intervention Description
One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
Description
Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Time Frame
From Day 1 of vaccination to Day 7 post vaccination
Title
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Description
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. All unsolicited AEs reported from day 1 to day 7 post vaccination were assessed. "Any" is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Time Frame
From Day 1 of vaccination to Day 7 post vaccination
Title
Number of Subjects Reporting Medically Attended AEs (MAAEs)
Description
MAAEs are defined as events that require a physician's visit or an emergency room visit. All reported MAAEs from day 1 to day 29 were assessed. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Time Frame
From Day 1 of vaccination to study termination (Day 29/early termination)
Title
Number of Subjects Reporting Serious AEs (SAEs)
Description
An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe, requires or prolongs subject's hospitalization, results in persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions), results in a congenital anomaly/birth defect, is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.
Time Frame
From Day 1 of vaccination to study termination (Day 29/early termination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals eligible for enrolment in this study are those: male and female subjects from 2 months to 55 years of the age at the time of Visit 1 (including all 55 years old subjects, up to one day before their 56th year birthday), who are scheduled to receive vaccination with MenACWY-CRM conjugate vaccine, according to the local prescribing information and routine clinical practice; to whom the nature of the study has been described and the subject or subject's parent/legal representative has provided written informed consent; whom the investigator believes that the subject can and will comply with the requirements of the protocol (e.g., completion of the Diary Card); who are in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator. Exclusion Criteria: 1. Contraindication, special warnings and/or precautions, as evaluated by the investigators, reported in the MenACWY-CRM conjugate vaccine Korean prescribing information. In particular, should not be included in the study a subject who has ever had: an allergic reaction to the active substances or any of the other ingredients of the study vaccine; an allergic reaction to diphtheria toxoid; an illness with high fever; however, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination. Special care should be taken for subjects having haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ansan
ZIP/Postal Code
15381
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Anyang
ZIP/Postal Code
431 062
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Bucheon
ZIP/Postal Code
14610
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Busan
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Changwon
ZIP/Postal Code
51503
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daegu
ZIP/Postal Code
706 090
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
DaeJeon
ZIP/Postal Code
34189
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daejeon
ZIP/Postal Code
34944
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Donghae
ZIP/Postal Code
25768
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gimhae-si
ZIP/Postal Code
51004
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Goyang-si, Gyeonggi-do
ZIP/Postal Code
10503
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Goyang-si
ZIP/Postal Code
10589
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Guro Gu
ZIP/Postal Code
152703
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gwangmyeong-si
ZIP/Postal Code
14250
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gwangmyeong
ZIP/Postal Code
484 5
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gyeonggi do
ZIP/Postal Code
158 774
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
16481
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gyeonggi-do
ZIP/Postal Code
463 707
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Incheon
ZIP/Postal Code
22214
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Incheon
ZIP/Postal Code
22397
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Incheon
ZIP/Postal Code
22736
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
JeJu
ZIP/Postal Code
63070
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Jeollanam Do
ZIP/Postal Code
530822
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Kyeonggido
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Pyeongtaek
ZIP/Postal Code
450 832
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
02598
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
02717
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
03966
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
04143
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
04154
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
04168
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
100 032
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
110746
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
130 702
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
130-711
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
132-703
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135 244
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135720
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135951
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
137 873
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
138 162
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
138201
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
140 887
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
143729
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
156-070
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
156755
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
158 885
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Ulsan
ZIP/Postal Code
683380
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Ulsan
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Yangju-si, Gyeonggi-do
ZIP/Postal Code
11440
Country
Korea, Republic of

12. IPD Sharing Statement

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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
Moon SY, Chung DR, Kim SW, Chang HH, Lee H, Jung DS, Kim YS, Jung SI, Ryu SY, Heo ST, Moon C, Ki HK, Son JS, Kwon KT, Shin SY, Lee JS, Lee SS, Rhee JY, Lee JA, Joung MK, Cheong HS, Peck KR, Song JH. Changing etiology of community-acquired bacterial meningitis in adults: a nationwide multicenter study in Korea. Eur J Clin Microbiol Infect Dis. 2010 Jul;29(7):793-800. doi: 10.1007/s10096-010-0929-8. Epub 2010 May 1.
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Obaro SK, Madhi SA. Bacterial pneumonia vaccines and childhood pneumonia: are we winning, refining, or redefining? Lancet Infect Dis. 2006 Mar;6(3):150-61. doi: 10.1016/S1473-3099(06)70411-X.
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PubMed Identifier
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Citation
Rouphael NG, Stephens DS. Neisseria meningitidis: biology, microbiology, and epidemiology. Methods Mol Biol. 2012;799:1-20. doi: 10.1007/978-1-61779-346-2_1.
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Trotter CL, Andrews NJ, Kaczmarski EB, Miller E, Ramsay ME. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet. 2004 Jul 24-30;364(9431):365-7. doi: 10.1016/S0140-6736(04)16725-1.
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Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea

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