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The purpose of this post market clinical investigation is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo in children above 2 years.
Healsea® Babykids is an isotonic saline solution based nasal spray supplemented with a natural Symbiofilm® extract (0.04%) isolated from marine bacteria. Symbiofilm® has in vitro antibiofilm activity and protects in vitro human nasal epithelial cells viability after Rhinovirus, Adenovirus, coronavirus OC43 and flu infection.
Healsea® Babykids is a nasal spray indicated in children above 2 years to clean and moisten the nose during colds and rhinitis.
The common cold is an acute viral infection of the upper respiratory tract, involving, to variable degrees, sneezing, nasal congestion and discharge (rhinorrhea), sore throat, cough, low-grade fever, headache, and malaise. Acute viral rhinitis is generally self-limiting. In children where the illness is not self-limiting and extends beyond 7-10 days, many agree that a bacterial infection is likely. Bacterial over infections and progression to a chronic state are favoured by the formation of biofilms, which facilitate bacterial growth and persistence as well as reducing antibiotic efficacy.
The aim of this study is to demonstrate that Healsea® Babykids alleviates symptoms of the acute rhinitis phase with better efficacy than isotonic saline solution used as Placebo.
The study comprises 2 parts:
- Part 1 (Day 1-Day 11): treatment of the acute phase
• with Healsea® Babykids, 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes of Healsea® Babykids) up to 10 days (20 intakes of the investigational device).
or • with isotonic nasal spray (Placebo), 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes of Placebo) up to 10 days (20 intakes of the investigational device).
- Part 2 (up to Day 15/Day 18): follow-up phase.
The study comprises two visits:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healsea Babykids | Experimental | Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). |
|
| Placebo | Placebo Comparator | The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healsea Babykids | Device | 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Full Analysis Set (FAS) | ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30). | From Day 1 to Day 10 |
| The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Per Protocol Set (PP) | ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30). | From Day 1 to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Each Cold Symptom (Questions 2 to 7 of the ARSSQ) in Both Groups | For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days. Duration may be censored at Visit 2. | Through study completion, up to Day 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rada MARKOVA, MD | Medical Center, Sofia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical center | Plovdiv | Bulgaria | ||||
| Medical center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24415465 | Result | Passioti M, Maggina P, Megremis S, Papadopoulos NG. The common cold: potential for future prevention or cure. Curr Allergy Asthma Rep. 2014 Feb;14(2):413. doi: 10.1007/s11882-013-0413-5. | |
| 32077450 | Result | Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healsea Babykids | Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . |
| FG001 | Placebo | The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healsea Babykids | Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Full Analysis Set (FAS) | ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30). | FAS: all the subjects from the Safety Population and with at least one post-baseline efficacy data | Posted | Mean | Standard Deviation | score on a scale*day | From Day 1 to Day 10 |
|
Adverse events were collected during the intervention through the study completion , up to day 18
Reporting of adverse events and of incidents (Incident: any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healsea Babykids | Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tonsillitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
In the absence of validated questionnaire assessing the severity and functional impact of an acute infectious rhinitis in young children, we used a customized non validated questionnaire, the ARSSQ (Acute Rhinitis Symptoms Severity Questionnaire).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Bernard Gout | Pharmndev Experts | +41798659000 | bgout@pharmndev.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2023 | Jan 3, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2023 | Jan 3, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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Randomized controlled trial double blind
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The investigational device and the comparator were indistinguishable. The comparator (isotonic nasal spray) used the same technology and the same packaging than Healsea Babykids. A white label with regulatory mentions for clinical investigations was stuck on the vial A white label with regulatory mentions was sticked on a white cardboard box used as secondary packaging. The IFUs (Bulgarian version) was included in the secondary packaging (on one face, Healsea Babykids, on the other face Placebo
| Placebo | Device | 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . |
|
| Duration of Quality-of-life Impairment (Questions 8 to 10 of the ARSSQ). | For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days. Duration may be censored at Visit 2. | Through study completion, up to Day 18 |
| Cumulative Number of Days of Concomitant Treatments Use That May Affect Common Cold Symptoms (Antibiotics, Antipyretics, Systemic or Local Mucolytics, Decongestants, Antitussives, Systemic and Topical Corticosteroids) | Concomitant treatments use (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | Through study completion, up to Day 18 |
| Cumulative Number of Days of Antibiotics Intake | Antibiotics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | through study completion , up to day 18 |
| Cumulative Number of Days of Antipyretics Intake | Antipyretics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | through study completion, up to day 18 |
| Cumulative Number of Days of Mucolytics Intake | Mucolytics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | Through study completion , up to day 18 |
| Cumulative Number of Days of Decongestants Use | Decongestants use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | through study completion, up to day 18 |
| Cumulative Number of Days of Antitussives Use | Antitussives use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | through study completion, up to day 18 |
| Cumulative Number of Days of Systemic and Topical Corticosteroids Use | Systemic and topical corticosteroids use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | Through study completion, up to day 18 |
| Sofia |
| Bulgaria |
| Medical center | Vratsa | Bulgaria |
| 12517470 | Result | Heikkinen T, Jarvinen A. The common cold. Lancet. 2003 Jan 4;361(9351):51-9. doi: 10.1016/S0140-6736(03)12162-9. |
| 28492494 | Result | Principi N, Esposito S. Nasal Irrigation: An Imprecisely Defined Medical Procedure. Int J Environ Res Public Health. 2017 May 11;14(5):516. doi: 10.3390/ijerph14050516. |
| Placebo |
The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Healsea® Babykids, nasal spray indistinguishable from the comparator. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ).
Healsea Babykids: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) .
| OG001 | Placebo | The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . |
|
|
|
| Secondary | Duration of Each Cold Symptom (Questions 2 to 7 of the ARSSQ) in Both Groups | For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days. Duration may be censored at Visit 2. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Number of days | Through study completion, up to Day 18 |
|
|
|
|
| Secondary | Duration of Quality-of-life Impairment (Questions 8 to 10 of the ARSSQ). | For each separate symptom, the duration is defined as the number of days between Day 1 and the first day the parent/legal guardian reports the patient not having this symptom ("Not present") for 2 consecutive days. Duration may be censored at Visit 2. | Full Analysis Set (FAS) | Posted | Mean | Standard Deviation | Duration in Days | Through study completion, up to Day 18 |
|
|
|
|
| Secondary | Cumulative Number of Days of Concomitant Treatments Use That May Affect Common Cold Symptoms (Antibiotics, Antipyretics, Systemic or Local Mucolytics, Decongestants, Antitussives, Systemic and Topical Corticosteroids) | Concomitant treatments use (antibiotics, antipyretics, systemic or local mucolytics, decongestants, antitussives, systemic and topical corticosteroids) will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | Full Analysis Set | Posted | Number | number of days | Through study completion, up to Day 18 |
|
|
|
|
| Secondary | Cumulative Number of Days of Antibiotics Intake | Antibiotics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | Full Analysis Set | Posted | Number | number of days | through study completion , up to day 18 |
|
|
|
|
| Secondary | Cumulative Number of Days of Antipyretics Intake | Antipyretics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | Full Analysis Set | Posted | Number | number of days | through study completion, up to day 18 |
|
|
|
|
| Secondary | Cumulative Number of Days of Mucolytics Intake | Mucolytics use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | Full Analysis Set | Posted | Number | number of days | Through study completion , up to day 18 |
|
|
|
|
| Secondary | Cumulative Number of Days of Decongestants Use | Decongestants use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | Full Analysis Set | Posted | Number | number of days | through study completion, up to day 18 |
|
|
|
|
| Secondary | Cumulative Number of Days of Antitussives Use | Antitussives use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | Full Analysis Set | Posted | Number | number of days | through study completion, up to day 18 |
|
|
|
|
| Secondary | Cumulative Number of Days of Systemic and Topical Corticosteroids Use | Systemic and topical corticosteroids use will be reported in the paper diary by parents/legal guardians throughout the study, validated by the investigator at the end of the study visit before being reported in the e-CRF. | Full Analysis Set | Posted | Number | number of days | Through study completion, up to day 18 |
|
|
|
|
| Primary | The Area Under the Curve (AUC) of the Global Score of the Acute Rhinitis Symptoms Severity Questionnaire (ARSSQ) During First 10 Days of Symptoms - Per Protocol Set (PP) | ARSSQ is a non-validated customized questionnaire. It includes 10 items assessing symptoms (questions 2 to 7), functional impairments (8 to 10), and global severity (question 1). Each item is scored from 0 (not present/no impact/ not sick) to 3 (severe, severe impact and very sick) for symptoms, functional impairment and global severity respectively. The questionnaire is to be completed in a diary once daily in the evening. The minimum ARSSQ score is zero (0) and the maximum ARSSQ score is thirty (30). | PP: efficacy population based on the FAS for subjects without major protocol deviation | Posted | Mean | Standard Deviation | score on a scale*day | From Day 1 to Day 10 |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 11 |
| 100 |
| EG001 | Placebo | The comparator is a saline isotonic nasal spray considered as inert Placebo i.e., neutral for the nasal mucosa. Subjects have to spray 2 puffs in each nostril 2 times per day with a minimum of 7-day-treatment period (14 intakes ) up to 10 days (20 intakes ). Placebo: 7-day-treatment period (14 intakes ) up to 10 days (20 intakes) . | 0 | 100 | 0 | 100 | 14 | 100 |
| otitis media acute | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Scarlet fever | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| bronchiolitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| laryngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| pharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| ear pain | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
|
| inner ear inflammation | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment | Adverse possibly related to the investigational device, ie incident reported to the competent authority per regulation EU 745/2017 , not rated as serious and did not lead to study /device discontinuation |
|
| pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment | Adverse possibly related to the investigational device, ie incident reported to the competent authority per regulation EU 745/2017 , not rated as serious and did not lead to study /device discontinuation |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment | Adverse possibly related to the investigational device, ie incident reported to the competent authority per regulation EU 745/2017 , not rated as serious and did not lead to study /device discontinuation |
|
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| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |