Clinical trial NCT01766206: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningococcal Disease
Keywords: conjugate vaccine
phase IV clinical trial
Neisseria meningitidis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-01-11
Enrollment: 3948
Sex: ALL
Minimum age (years): 2
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)
timeFrame: From Day 1 of vaccination to Day 7 post vaccination
measure: Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
timeFrame: From Day 1 of vaccination to Day 7 post vaccination
measure: Number of Subjects Reporting Medically Attended AEs (MAAEs)
timeFrame: From Day 1 of vaccination to study termination (Day 29/early termination)
measure: Number of Subjects Reporting Serious AEs (SAEs)
timeFrame: From Day 1 of vaccination to study termination (Day 29/early termination)
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: GSK Investigational Site
city: Anyang
country: Korea, Republic of
facility: GSK Investigational Site
city: Bucheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Changwon
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: DaeJeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Daejeon
country: Korea, Republic of
facility: GSK Investigational Site
city: Donghae
country: Korea, Republic of
facility: GSK Investigational Site
city: Gimhae-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Guro Gu
country: Korea, Republic of
facility: GSK Investigational Site
city: Gwangmyeong-si
country: Korea, Republic of
facility: GSK Investigational Site
city: Gwangmyeong
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: Incheon
country: Korea, Republic of
facility: GSK Investigational Site
city: JeJu
country: Korea, Republic of
facility: GSK Investigational Site
city: Jeollanam Do
country: Korea, Republic of
facility: GSK Investigational Site
city: Kyeonggido
country: Korea, Republic of
facility: GSK Investigational Site
city: Pyeongtaek
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Ulsan
country: Korea, Republic of
facility: GSK Investigational Site
city: Ulsan
country: Korea, Republic of
facility: GSK Investigational Site
city: Yangju-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
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