E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study will collect real-world post-vaccination adverse events. |
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E.1.1.1 | Medical condition in easily understood language |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this PMS is to collect safety data on Bexsero vaccine from participants receiving at least one dose of vaccine administered as per routine practice according to the approved prescribing information (PI). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Participants, aged two months or older at the time of first vaccination, who receive Bexsero administered as per routine practice according to the approved PI in Korea. Participants with incomplete vaccination schedule will still be eligible for inclusion. • Participants who have provided the written informed consent. For participants who are below the legal age of consent, written informed consent must be obtained from the parent(s)/ legally acceptable representative (LAR) (s) of the participant and informed assent must be obtained from the participant according to ethics committee (EC) requirement as well as local law. For participants (infants, toddlers, and children) who are too young to provide informed assent, the informed assent can be waived, and only legal consent will be obtained from their parent(s)/LAR(s)
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E.4 | Principal exclusion criteria |
• Child in care (CiC): CiC are children who have been placed under the control or protection of an agency, organization, institution or entity by the courts, the government, or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of CiC can include children cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of CiC does not include a child who is adopted or has appointed legal guardian. • Participants who, based on the judgement of the prescribing physician, have contraindication for receiving Bexsero, as indicated in the locally approved Product Information, or are not appropriate for vaccination with Bexsero for any other reason
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of occurrences of adverse events (AEs) 2. Percentage of participants with AEs 3. Number of occurrences of unexpected adverse events (UAEs) and unexpected adverse drug reaction (UADRs) 4. Percentage of participants with UAEs and UADRs 5. Number of occurrences of serious adverse events (SAEs) and serious adverse drug reaction (SADRs) 6. Percentage of participants with SAEs and SADRs 7. Number of occurrences of specific adverse events (SpAEs) 8. Percentage of participants with SpAEs |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1, 2, 3, 4, 5, 6, 7, 8. During the 30 days (including the day of intervention) following each dose, during the 6-year study period (May 2022-May 2028) |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of Study corresponds to SAC date as defined in the protocol. For PMS studies which have completed a pre-defined re-examination period determined by MFDS, (re-examination period is from start date of the PMS study to the timepoint at which no more data are expected to be received to develop the final report), SAC date will correspond to the end of the re-examination period encompassing domestic and foreign safety information derived from routine pharmacovigilance. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 18 |