Phase 4
N=3,939
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
Bottom Line
View on ClinicalTrials.gov: NCT01766206 ↗Enrolled (actual)
3,939
Serious AEs
0.2%
Results posted
Sep 2018
Primary outcome: Primary: Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) — 67; 32; 28; 110 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- MenACWY-CRM (Menveo) (Biological)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs) |
67; 32; 28; 110; 126; 219 | — |
| PRIMARY Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) |
82; 56; 18; 8; 17; 5 | — |
| PRIMARY Number of Subjects Reporting Medically Attended AEs (MAAEs) |
238; 120; 28; 20; 16; 5 | — |
| PRIMARY Number of Subjects Reporting Serious AEs (SAEs) |
3; 3; 0; 2; 0; 0 | — |
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:
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT01766206). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.