Last updated: 02/18/2020 07:20:18
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
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects reporting any local and systemic solicited Adverse Events (AEs)
Timeframe: From Day 1 of vaccination to Day 7 post vaccination
Number of subjects reporting any unsolicited adverse events (AEs)
Timeframe: From Day 1 of vaccination to Day 7 post vaccination
Number of subjects reporting medically attended AEs (MAAEs)
Timeframe: From Day 1 of vaccination to study termination (Day 29/early termination)
Number of subjects reporting serious AEs (SAEs)
Timeframe: From Day 1 of vaccination to study termination (Day 29/early termination)
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
3948
Primary completion date:
2018-22-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical 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.
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.
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.
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.
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.
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.
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.
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.
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.
Yoo BW et al. (2019) 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. 1-8.
Medical condition
Meningococcal disease
Product
GSK3536820A
Collaborators
Not applicable
Study date(s)
March 2013 to January 2018
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
2 months - 55 years
Accepts healthy volunteers
Yes
- 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
- 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;
Inclusion and exclusion 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).
Trial location(s)
Showing 1 - 6 of 29 Results
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2018-22-01
Actual study completion date
2018-22-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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