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

NCT01766206 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 205341V59_62
• Study Type: interventional
• Target: 3,948
• Locations: 1 country
• Sites: 54

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.

Conditions

Meningococcal Disease

Keywords

conjugate vaccine; phase IV clinical trial; Neisseria meningitidis

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

MenACWY-CRM Group

EXPERIMENTAL

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)

Interventions

MenACWY-CRM (Menveo) BIOLOGICAL

One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.

MenACWY-CRM Group

Eligibility Criteria

• Age: 2 Months - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \. 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (54)

GSK Investigational Site

Ansan, 15381, South Korea

Location

GSK Investigational Site

Anyang, 431 062, South Korea

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GSK Investigational Site

Bucheon-si, 14610, South Korea

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GSK Investigational Site

Busan, South Korea

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GSK Investigational Site

Changwon, 51503, South Korea

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GSK Investigational Site

Daegu, 706 090, South Korea

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GSK Investigational Site

Daejeon, 34189, South Korea

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GSK Investigational Site

Daejeon, 34944, South Korea

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GSK Investigational Site

Donghae, 25768, South Korea

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GSK Investigational Site

Gimhae, 51004, South Korea

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GSK Investigational Site

Goyang-si, 10589, South Korea

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GSK Investigational Site

Goyang-si, Gyeonggi-do, 10503, South Korea

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GSK Investigational Site

Guro Gu, 152703, South Korea

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GSK Investigational Site

Gwangmyeong, 14250, South Korea

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GSK Investigational Site

Gwangmyeong, 484 5, South Korea

Location

GSK Investigational Site

Gyeonggi-do, 158 774, South Korea

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GSK Investigational Site

Gyeonggi-do, 16481, South Korea

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GSK Investigational Site

Gyeonggi-do, 463 707, South Korea

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GSK Investigational Site

Gyeonggi-do, South Korea

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GSK Investigational Site

Incheon, 22214, South Korea

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GSK Investigational Site

Incheon, 22397, South Korea

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GSK Investigational Site

Incheon, 22736, South Korea

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GSK Investigational Site

Jeju City, 63070, South Korea

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GSK Investigational Site

Jeollanam Do, 530822, South Korea

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GSK Investigational Site

Kyeonggido, South Korea

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GSK Investigational Site

Pyeongtaek-si, 450 832, South Korea

Location

GSK Investigational Site

Seoul, 02598, South Korea

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GSK Investigational Site

Seoul, 02717, South Korea

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GSK Investigational Site

Seoul, 03966, South Korea

Location

GSK Investigational Site

Seoul, 04143, South Korea

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GSK Investigational Site

Seoul, 04154, South Korea

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GSK Investigational Site

Seoul, 04168, South Korea

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GSK Investigational Site

Seoul, 06591, South Korea

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GSK Investigational Site

Seoul, 100 032, South Korea

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GSK Investigational Site

Seoul, 110746, South Korea

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GSK Investigational Site

Seoul, 130 702, South Korea

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GSK Investigational Site

Seoul, 130-702, South Korea

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GSK Investigational Site

Seoul, 130-711, South Korea

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GSK Investigational Site

Seoul, 132-703, South Korea

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GSK Investigational Site

Seoul, 135 244, South Korea

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GSK Investigational Site

Seoul, 135720, South Korea

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GSK Investigational Site

Seoul, 135951, South Korea

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GSK Investigational Site

Seoul, 137 873, South Korea

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GSK Investigational Site

Seoul, 138 162, South Korea

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GSK Investigational Site

Seoul, 138201, South Korea

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GSK Investigational Site

Seoul, 140 887, South Korea

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GSK Investigational Site

Seoul, 143729, South Korea

Location

GSK Investigational Site

Seoul, 156-070, South Korea

Location

GSK Investigational Site

Seoul, 156755, South Korea

Location

GSK Investigational Site

Seoul, 158 885, South Korea

Location

GSK Investigational Site

Seoul, South Korea

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GSK Investigational Site

Ulsan, 683380, South Korea

Location

GSK Investigational Site

Ulsan, South Korea

Location

GSK Investigational Site

Yangju-si, Gyeonggi-do, 11440, South Korea

Location

Related Publications (11)

• 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.

  PMID: 20849427 BACKGROUND

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

  PMID: 19050348 BACKGROUND

• 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.

  PMID: 20514311 BACKGROUND

• 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.

  PMID: 21434801 BACKGROUND

• 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.

  PMID: 20132098 BACKGROUND

• 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.

  PMID: 21286006 BACKGROUND

• 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.

  PMID: 20432052 BACKGROUND

• 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.

  PMID: 16500596 BACKGROUND

• 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.

  PMID: 21993636 BACKGROUND

• 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.

  PMID: 15276396 BACKGROUND

• 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.

  PMID: 31634044 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

sss42438@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 11, 2013
• Study Start: March 15, 2013
• Primary Completion: January 22, 2018
• Study Completion: January 22, 2018
• Last Updated: September 21, 2018
• Results First Posted: September 21, 2018

Record last verified: 2018-07

Locations

KR (54)