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

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.

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Disease
• Intervention / Treatment: Biological: MenACWY-CRM (Menveo)

• Study Type: Interventional
• Enrollment (Actual): 3948
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of, 15381
    • GSK Investigational Site
  • Anyang, Korea, Republic of, 431 062
    • GSK Investigational Site
  • Bucheon, Korea, Republic of, 14610
    • GSK Investigational Site
  • Busan, Korea, Republic of
    • GSK Investigational Site
  • Changwon, Korea, Republic of, 51503
    • GSK Investigational Site
  • DaeJeon, Korea, Republic of, 34189
    • GSK Investigational Site
  • Daegu, Korea, Republic of, 706 090
    • GSK Investigational Site
  • Daejeon, Korea, Republic of, 34944
    • GSK Investigational Site
  • Donghae, Korea, Republic of, 25768
    • GSK Investigational Site
  • Gimhae-si, Korea, Republic of, 51004
    • GSK Investigational Site
  • Goyang-si, Korea, Republic of, 10589
    • GSK Investigational Site
  • Goyang-si, Gyeonggi-do, Korea, Republic of, 10503
    • GSK Investigational Site
  • Guro Gu, Korea, Republic of, 152703
    • GSK Investigational Site
  • Gwangmyeong, Korea, Republic of, 484 5
    • GSK Investigational Site
  • Gwangmyeong-si, Korea, Republic of, 14250
    • GSK Investigational Site
  • Gyeonggi do, Korea, Republic of, 158 774
    • GSK Investigational Site
  • Gyeonggi-do, Korea, Republic of, 16481
    • GSK Investigational Site
  • Gyeonggi-do, Korea, Republic of, 463 707
    • GSK Investigational Site
  • Gyeonggi-do, Korea, Republic of
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 22214
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 22397
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 22736
    • GSK Investigational Site
  • JeJu, Korea, Republic of, 63070
    • GSK Investigational Site
  • Jeollanam Do, Korea, Republic of, 530822
    • GSK Investigational Site
  • Kyeonggido, Korea, Republic of
    • GSK Investigational Site
  • Pyeongtaek, Korea, Republic of, 450 832
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 06591
    • GSK Investigational Site
  • Seoul, Korea, Republic of
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 02598
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 02717
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 03966
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 04143
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 04154
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 04168
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 100 032
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 110746
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 130 702
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 130-702
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 130-711
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 132-703
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 135 244
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 135720
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 135951
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 137 873
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 138 162
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 138201
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 140 887
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 143729
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 156-070
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 156755
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 158 885
    • GSK Investigational Site
  • Ulsan, Korea, Republic of, 683380
    • GSK Investigational Site
  • Ulsan, Korea, Republic of
    • GSK Investigational Site
  • Yangju-si, Gyeonggi-do, Korea, Republic of, 11440
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MenACWY-CRM Group; Healthy subjects from 2 months to 55 years of age in South Korea, who received MenACWY-CRM (Menveo) vaccination, according to routine clinical care.	Biological: MenACWY-CRM (Menveo); One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Day 1 of vaccination to Day 7 post vaccination
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.	From Day 1 of vaccination to Day 7 post vaccination
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.	From Day 1 of vaccination to study termination (Day 29/early termination)
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.	From Day 1 of vaccination to study termination (Day 29/early termination)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Al-Tawfiq JA, Clark TA, Memish ZA. Meningococcal disease: the organism, clinical presentation, and worldwide epidemiology. J Travel Med. 2010 Sep-Oct;17 Suppl:3-8. doi: 10.1111/j.1708-8305.2010.00448.x. No abstract available.
• Bae SM, Kang YH. Serological and genetic characterization of meningococcal isolates in Korea. Jpn J Infect Dis. 2008 Nov;61(6):434-7.
• Cho HK, Lee H, Kang JH, Kim KN, Kim DS, Kim YK, Kim JS, Kim JH, Kim CH, Kim HM, Park SE, Oh SH, Chung EH, Cha SH, Choi YY, Hur JK, Hong YJ, Lee HJ, Kim KH. The causative organisms of bacterial meningitis in Korean children in 1996-2005. J Korean Med Sci. 2010 Jun;25(6):895-9. doi: 10.3346/jkms.2010.25.6.895. Epub 2010 May 24.
• Deasy A, Read RC. Challenges for development of meningococcal vaccines in infants and children. Expert Rev Vaccines. 2011 Mar;10(3):335-43. doi: 10.1586/erv.11.3.
• Hill DJ, Griffiths NJ, Borodina E, Virji M. Cellular and molecular biology of Neisseria meningitidis colonization and invasive disease. Clin Sci (Lond). 2010 Feb 9;118(9):547-64. doi: 10.1042/CS20090513.
• Lee JH, Cho HK, Kim KH, Kim CH, Kim DS, Kim KN, Cha SH, Oh SH, Hur JK, Kang JH, Kim JH, Kim YK, Hong YJ, Chung EH, Park SE, Choi YY, Kim JS, Kim HM, Choi EH, Lee HJ. Etiology of invasive bacterial infections in immunocompetent children in Korea (1996-2005): a retrospective multicenter study. J Korean Med Sci. 2011 Feb;26(2):174-83. doi: 10.3346/jkms.2011.26.2.174. Epub 2011 Jan 24.
• 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.
• 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.
• 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.
• 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.
• Yoo BW, Jung HL, Byeon YS, Han DK, Jeong NY, Curina C, Moraschini L, Kim SJ, Bhusal C, Pellegrini M, Miao Y. Results from a large post-marketing safety surveillance study in the Republic of Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 2 months-55 years. Hum Vaccin Immunother. 2020 Jun 2;16(6):1260-1267. doi: 10.1080/21645515.2019.1670125. Epub 2019 Oct 25.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2013
• Primary Completion (Actual): January 22, 2018
• Study Completion (Actual): January 22, 2018

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: January 9, 2013
• First Posted (Estimate): January 11, 2013

Study Record Updates

• Last Update Posted (Actual): September 21, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Neisseria meningitidis; conjugate vaccine; phase IV clinical trial
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: 205341; V59_62 (Other Identifier: Novartis)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• product manufactured in and exported from the U.S.: Yes