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

Meningococcal Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766206
• Other study ID #: 205341
• Secondary ID: V59_62
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2013
• Est. completion date: January 22, 2018

Study information

• Verified date: July 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3948
• Est. completion date: January 22, 2018
• Est. primary completion date: January 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Meningococcal Disease
• Meningococcal Infections

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Ansan
Korea, Republic of	GSK Investigational Site	Anyang
Korea, Republic of	GSK Investigational Site	Bucheon
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Changwon
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	DaeJeon
Korea, Republic of	GSK Investigational Site	Daejeon
Korea, Republic of	GSK Investigational Site	Donghae
Korea, Republic of	GSK Investigational Site	Gimhae-si
Korea, Republic of	GSK Investigational Site	Goyang-si
Korea, Republic of	GSK Investigational Site	Goyang-si, Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Guro Gu
Korea, Republic of	GSK Investigational Site	Gwangmyeong
Korea, Republic of	GSK Investigational Site	Gwangmyeong-si
Korea, Republic of	GSK Investigational Site	Gyeonggi do
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	JeJu
Korea, Republic of	GSK Investigational Site	Jeollanam Do
Korea, Republic of	GSK Investigational Site	Kyeonggido
Korea, Republic of	GSK Investigational Site	Pyeongtaek
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Ulsan
Korea, Republic of	GSK Investigational Site	Ulsan
Korea, Republic of	GSK Investigational Site	Yangju-si, Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (10)

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. — View Citation

Bae SM, Kang YH. Serological and genetic characterization of meningococcal isolates in Korea. Jpn J Infect Dis. 2008 Nov;61(6):434-7. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View 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. — View Citation

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. Review. — View 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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)