| 9 Octubre 2013 - 1:47pm por BIOCEN | 14 Octubre 2022 - 9:35am por BIOCEN | ||
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Imported with node_import. | |||
| Cambios a Regulatory instance to authorize the initiation of the study | |||
| - | Center for State Control of the Quality of Drugs(CECMED) | + | Center for State Control of Drugs, Medical Devices and Equipment (CECMED) |
| Cambios a Authorization date | |||
| - | 2013-04-11 04:00:00 | + | 2013-04-11 00:00:00 |
| Cambios a Reference number | |||
| - | 445/05-001-13B | + | 445/05-001-13-B |
| Cambios a Clinical sites | |||
| - | Not applicable. In the protocol all the investigators are considered principal investigators. | + | Havana, Pediatric Hospital Ángel Arturo Aballí, Emilia Rivero Pino, MD, Specialist of Frist Degree in Allergology |
| + | Havana, Pediatric Hospital Pedro Borras, Julia Eugenia Urbina Reynaldo, MD, Specialist of Frist Degree in Allergology | ||
| + | Havana, Center of Medical Surgical Investigations (CIMEQ), Omar Herrera Barrios, MD, Specialist of Frist Degree in Allergology | ||
| + | Havana, Clinic of 43, Omar Herrera Barrios, MD, Specialist of Frist Degree in Allergology | ||
| + | Holguín, Pediatric Hospital Octavio de la Concepción y la Pedraja, Sara Iris Romero Cuenca, MD, Specialist of Frist Degree in Allergology | ||
| + | Sancti Spíritus, Pediatric Docent Hospital José Martí, Álvaro Tomás González Marín, MD, Specialist of Second Degree in Allergology | ||
| + | Sancti Spíritus, University Policlinic Juan M. Martínez Puentes (Policlinic North), Álvaro González Iglesias, MD, Specialist of Frist Degree in Allergology | ||
| + | Sancti Spíritus, University Policlinic Manuel de Jesús Lara Cantero, Adriana Albert Montero, MD, Specialist of Frist Degree in Allergology | ||
| + | Sancti Spíritus, University Policlinic Ramón Balboa Monzón, Anabel Ruiz Cárdenas, MD, Specialist of Frist Degree in Allergology | ||
| + | Sancti Spíritus, Docent Policlinic of family Camilo Cienfuegos, Lidia Mabel Pérez Reyes, MD, Specialist of Frist Degree in Allergology | ||
| + | Sancti Spíritus, University Policlinic, Antonio Ávila Valdivia, Dra. Ropsalig Guerra Marzo, MD, Specialist of Frist Degree in Allergology | ||
| + | Camagüey, Pediatric Hospital Eduardo Agramonte Piña, Adianez Sugrañes Montalván, MD, Specialist of Frist Degree in Allergology | ||
| + | Santiago de Cuba, Pediatric South Docent Hospital Antonio María Béguez César, Caridad Sanchez Silot, MD, Specialist of Second Degree in Allergology | ||
| Cambios a Research ethics committees | |||
| - | Pediatric Hospital William Soler, September 27, 2012 Pediatric Hospital Juan Manuel Marquez, October 15, 2012 Pediatric Hospital Angel Arturo Aballi, October 3, 2012 | + | Pediatric Hospital Juan Manuel Marquez, December 19, 2011, April 11, 2018 |
| + | Pediatric Hospital Angel Arturo Aballi, December 7, 2011, April 3, 2018 | ||
| + | Pediatric Hospital Pedro Borras, March 26, 2018 | ||
| + | Center of Medical Surgical Investigations (CIMEQ), April 19, 2018 | ||
| + | Clinic of 43, April 30, 2018 | ||
| + | Pediatric Hospital Octavio de la Concepción y la Pedraja, April 2, 2018 | ||
| + | Allergy Clinic of Policlinic Máximo Gómez Báez, April 10, 2018 | ||
| + | Pediatric Docent Hospital José Martí, March 7, 2018 | ||
| + | University Policlinic Juan M. Martínez Puentes (Policlinic North), March 5, 2018 | ||
| + | University Policlinic Rudelsindo García del Rijo (Policlinic South), March 9, 2018 | ||
| + | University Policlinic Manuel de Jesús Lara Cantero, March 20, 2018 | ||
| + | University Policlinic Ramón Balboa Monzón, February 13, 2018 | ||
| + | Docent Policlinic of family Camilo Cienfuegos, March 26, 2018 | ||
| + | University Policlinic, Antonio Ávila Valdivia, March 26, 2018 | ||
| + | Pediatric Hospital Eduardo Agramonte Piña, March 26, 2018 | ||
| + | Pediatric South Docent Hospital Antonio María Béguez César, March 6, 2018 | ||
| Cambios a Recruitment status | |||
| - | Recruiting | + | Complete |
| Cambios a Data sharing plan | |||
| - | + | Not entered | |
| Cambios a Date of first enrollment | |||
| - | 2013-10-16 04:00:00 | + | 2013-09-16 00:00:00 |
| Cambios a First name | |||
| - | Pediatric Hospital “William Soler”, Concepción Insua, MD. Specialist of 1er Degree in Immunology . Pediatric Hospital “Juan Manuel Marquez”, Rafaela Andina Corrales, MD. Specialist of 1er Degree in Allergology. Pediatric Hospital “Angel Arturo Aballi”, Marlene Jiménez Frandin MD. Specialist of 1er Degree in Allergology. | + | Rafaela |
| Cambios a Primary outcome(s) | |||
| - | Symptom score: Dyspnea, cough, expectoration, wheeze and tightness (four-digit score: 0 = non symptom, 1 = mild, 2 = moderate, 3 = severe). Measuring time: daily during 6 months. Consumption of medications (three-digit score: 0= no use, 1= use beta-2 agonists, metilxantine, ephedrine, adrenaline, 2 = corticosteroids)). Measuring time: daily during 6 months. Determination of Peak Expiratory Flow (PEF), (using standard meter of PEF: FERRARIS POCKETPEAK Measuring time: twice a day during 6 months. Skin reactivity: (value Ch10: relative allergen concentration causing in the patient a similar wheal to induced wheal by a HCL histamine solution (10 mg/mL= 54.3 mmol/L de Histamina base)). Measuring time: 6 months. Quality of life (PAQLQ(S)). Measuring time: 6 months. | + | 1. Symptom score: Dyspnea, cough, expectoration, wheeze and tightness (four-digit score: 0 = non symptom, 1 = mild, 2 = moderate, 3 = severe). Measuring time: daily during 6 months. Consumption of medications (three-digit score: 0= no use, 1= use beta-2 agonists, metilxantine, ephedrine, adrenaline, 2 = corticosteroids)). Measuring time: daily during 6 months.
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| + | 2. Determination of Peak Expiratory Flow (PEF), (using standard meter of PEF: FERRARIS POCKETPEAK Measuring time: twice a day during 6 months. Skin reactivity: (value Ch10: relative allergen concentration causing in the patient a similar wheal to induced wheal by a HCL histamine solution (10 mg/mL= 54.3 mmol/L de Histamina base)). Measuring time: Pretreatment and 6 months.
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| + | 3. Quality of life (PAQLQ(S)). Measuring time: Pretreatment and 6 months. | ||
| Cambios a Last name | |||
| - | Not entered | + | Andina Corrales |
| Cambios a Medical Specialty | |||
| - | + | Specialist of Frist Degree in Allergology | |
| Cambios a Key secondary outcomes | |||
| - | Allergen-specific antibodies (antibody titer determination and IgG4 serum allergen-specific IgE in patients using an indirect ELISA). Measuring time: 6 months. Adverse events (AE). Measuring time: during 6 months. - Occurrence of some AE in the patient (yes/no). - Description of the AE (Name of adverse event). - According to available previous information (unexpected and expected) - According to its localization the expected AE (World Allergy Organization Criterion: local and systemic AE (0= Nonspecific Symptoms, I= Mild systemic reactions, II= Moderate systemic reactions, III= Severe (nonlife-threatening) systemic reactions, IV= Anaphylactic shock)). - Duration of the AE (Difference of dates between beginning and termination of event) - Intensity of the AE (Light, Moderate, Severe) - Graveness of the AE (Serious, No serious) - Attitude regarding the treatment in study (without changes, dose modification, temporary or definitive interruption of the treatment in study) - Result of the AE (Recovered, Improved, Persists or sequels) - Relationship of causation of the AE (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated) | + | 1. Allergen-specific antibodies (antibody titer determination and IgG4 serum allergen-specific IgE in patients using an indirect ELISA). Measuring time: 6 months.
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| + | 2. Adverse events (AE). Measuring time: during 6 months. - Occurrence of some AE in the patient (yes/no). - Description of the AE (Name of adverse event). - According to available previous information (unexpected and expected) - According to its localization the expected AE (World Allergy Organization Criterion: local and systemic AE (0= Nonspecific Symptoms, I= Mild systemic reactions, II= Moderate systemic reactions, III= Severe (nonlife-threatening) systemic reactions, IV= Anaphylactic shock)). - Duration of the AE (Difference of dates between beginning and termination of event) - Intensity of the AE (Light, Moderate, Severe) - Seriousness of the AE (Serious, No serious) - Attitude regarding the treatment in study (without changes, dose modification, temporary or definitive interruption of the treatment in study) - Result of the AE (Recovered, Improved, Persists or sequels) - Relationship of causation of the AE (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated). Measuring time: Daily during the frits 23 days and monthly until 6 months. | ||
| Cambios a Affiliation | |||
| - | Not entered | + | Pediatric Hospital “Juan Manuel Márquez” |
| Cambios a Intervention(s) | |||
| - | Group A: VALERGEN-DP Group B: VALERGEN-BT In each group there are 3 schemes. In each scheme, the treatment is presented as: - Increasing Phase: Vaccination, sublingually, daily for 23 days - Maintenance phase: Vaccination, sublingually, 2 times per week until completing 6 months Increasing Phase. The vaccine will be administered in volumes of 1, 2, 3, 4, 6, 8 and 10 drops depending on day 1, 2, 3, 4, 5, 6 and 7 of each week, respectively. Group A Scheme 1. It begins in the concentration of 2UB/mL Week 1. Day 1 to 7. Concentration of 2 BU / mL Week 2. Day 8 to 14. Concentration of 20 BU / mL Week 3. Day 15 to 21. Concentration of 200 BU / mL Week 4. Day 22 and 23. Concentration of 2000 BU / mL Group A Scheme 2. It begins in the concentration of 20 UB/mL Week 1. Day 1 to 7. Concentration of 20 BU / mL Week 2. Day 8 to 14. Concentration of 200 BU / mL Week 3. Day 15 to 21. Concentration of 2000 BU / mL Week 4. Day 22 and 23. Concentration of 20000 BU / mL Group A Scheme 3. It begins in the concentration of 200 UB/mL Week 1. Day 1 to 7. Concentration of 200 BU / mL Week 2. Day 8 to 14. Concentration of 2000 BU / mL Week 3. Day 15 to 21. Concentration of 20000 BU / mL Week 4. Day 22 and 23. Concentration of 200000 BU / mL Group B Scheme 1. It begins in the concentration of 2UB/mL Week 1. Day 1 to 7. Concentration of 2 BU / mL Week 2. Day 8 to 14. Concentration of 20 BU / mL Week 3. Day 15 to 21. Concentration of 200 BU / mL Week 4. Day 22 and 23. Concentration of 2000 BU / mL Group B Scheme 2. It begins in the concentration of 20 UB/mL Week 1. Day 1 to 7. Concentration of 20 BU / mL Week 2. Day 8 to 14. Concentration of 200 BU / mL Week 3. Day 15 to 21. Concentration of 2000 BU / mL Week 4. Day 22 and 23. Concentration of 20000 BU / mL Group B Scheme 3. It begins in the concentration of 200 UB/mL Week 1. Day 1 to 7. Concentration of 200 BU / mL Week 2. Day 8 to 14. Concentration of 2000 BU / mL Week 3. Day 15 to 21. Concentration of 20000 BU / mL Week 4. Day 22 and 23. Concentration of 200000 BU / mL Maintenance phase. It begins when the patient reaches the maximum tolerated dose (range between 2 and 400 000 BU / mL). The maximum tolerated dose is defined as the dose at which no systemic reactions were observed. For patients receiving the whole increasing phase, the maintenance dose will be 200, 2000 and 20000 UB as Scheme 1, 2 or 3 respectively. In all cases, be applied at this stage 2 drops, 2 times per week. In both groups, the second scheme is the control group. | + | Group A: VALERGEN-DP
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| + | Group B: VALERGEN-BT
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| + | In each group, there are 3 schemes. In each scheme, the treatment has an increasing and maintenance phase.
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| + | - Increasing phase: Sublingual Vaccination, daily for 23 days
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| + | - Maintenance phase: Vaccination, sublingually, 2 times per week until completing 6 months Increasing Phase. Vaccine will be administered in volumes of 1, 2, 3, 4, 6, 8 and 10 drops depending on day 1, 2, 3, 4, 5, 6 and 7 of each week, respectively.
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| + | 1. Group A1: Schedule 1. It begins in the concentration of 2UB/mL Week 1. Day 1 to 7. Concentration of 2 BU / mL Week 2. Day 8 to 14. Concentration of 20 BU / mL Week 3. Day 15 to 21. Concentration of 200 BU / mL Week 4. Day 22 and 23. Concentration of 2000 BU / mL
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| + | 2. Group A2: Schedule 2. It begins in the concentration of 20 UB/mL Week 1. Day 1 to 7. Concentration of 20 BU / mL Week 2. Day 8 to 14. Concentration of 200 BU / mL Week 3. Day 15 to 21. Concentration of 2000 BU / mL Week 4. Day 22 and 23. Concentration of 20000 BU / mL 3. Group A3: Schedule 3. It begins in the concentration of 200 UB/mL Week 1. Day 1 to 7. Concentration of 200 BU / mL Week 2. Day 8 to 14. Concentration of 2000 BU / mL Week 3. Day 15 to 21. Concentration of 20000 BU / mL Week 4. Day 22 and 23. Concentration of 200000 BU / mL
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| + | 4. Group B1: Schedule 1. It begins in the concentration of 2UB/mL Week 1. Day 1 to 7. Concentration of 2 BU / mL Week 2. Day 8 to 14. Concentration of 20 BU / mL Week 3. Day 15 to 21. Concentration of 200 BU / mL Week 4. Day 22 and 23. Concentration of 2000 BU / mL.
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| + | 5. Group B2: Schedule 2. It begins in the concentration of 20 UB/mL Week 1. Day 1 to 7. Concentration of 20 BU / mL Week 2. Day 8 to 14. Concentration of 200 BU / mL Week 3. Day 15 to 21. Concentration of 2000 BU / mL Week 4. Day 22 and 23. Concentration of 20000 BU / mL 6. Group B3: Schedule 3. It begins in the concentration of 200 UB/mL Week 1. Day 1 to 7. Concentration of 200 BU / mL Week 2. Day 8 to 14. Concentration of 2000 BU / mL Week 3. Day 15 to 21. Concentration of 20000 BU / mL Week 4. Day 22 and 23. Concentration of 200000 BU / mL.
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| + | |||
| + | - Maintenance phase. It begins when the patient reaches the maximum tolerated dose (range between 2 and 400 000 BU / mL). The maximum tolerated dose is defined as the dose at which no systemic reactions were observed. For patients receiving the whole increasing phase, the maintenance dose will be 200, 2000 and 20000 UB as Scheme 1, 2 or 3 respectively. In all cases, be applied at this phase 2 drops, twice for week. In both groups, the second schedule is the control group.
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| Cambios a Postal address | |||
| - | Not entered | + | 31 Avenue and 76 Street, Marianao |
| Cambios a City | |||
| - | Not entered | + | Havana |
| Cambios a Country | |||
| - | Not entered | + | Cuba |
| Cambios a Zip Code | |||
| - | Not entered | + | 11500 |
| Cambios a Inclusion criteria | |||
| - | 1. Asthmatic allergic patients with a clinical positive history of allergic symptoms provoked by the house-dust. 2. It proves cutaneous positive with the allergen extracts of D. pteronyssinus or B. Tropicalis to 20 000 UB / mL Keeping in mind that the cutaneous answer for the respective allergen is predominant when compared to that obtained with other mites, the patients will be included in one of the two groups: A: D. pteronyssinus, B: B. tropicalis) 3. Patients clinically diagnosed as extrinsic asthmatics that, according to the clinical-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Agreement on Asthma Diagnosis and Treatment. 4. Age between 5 and 15 years. 5. Any sex and race. 6. Patient whose parents or tutors express their informed consent in writing to participate in the trial | + | 1. Asthmatic allergic patients with a clinical positive history of allergic symptoms provoked by the house-dust.
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| + | 2. It proves cutaneous positive with the allergen extracts of D. pteronyssinus or B. Tropicalis to 20 000 UB / mL Keeping in mind that the cutaneous answer for the respective allergen is predominant when compared to that obtained with other mites, the patients will be included in one of the two groups: A: D. pteronyssinus, B: B. tropicalis)
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| + | 3. Patients clinically diagnosed as extrinsic asthmatics that, according to the clinical-therapeutic identification booklet, are classified as mild or moderate persistent patients in keeping with the International Agreement on Asthma Diagnosis and Treatment.
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| + | 4. Age between 5 and 15 years.
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| + | 5. Any sex and color skin.
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| + | 6. Patient whose parents or tutors express their informed consent in writing to participate in the trial. | ||
| Cambios a Exclusion criteria | |||
| - | 1. Patients on allergenic extract immunotherapy during the two years before. 2. Patients classified as intermittent or severe persistent asthmatics after being interviewed. 3. Patients with a diagnostic of an autoimmune disease. 4. Generalized severe eczema. 5. Patients with diagnosed tumoral disease. 6. Patients on betablocker treatment. 7. Patients with psychiatric disorders. 8. Patients not cooperating with treatment. 9. Patients who needed,at least a year before the study, immunostimulant or immunosuppressor treatment (no corticosteroids) including interferon and cyclosporine A. 10. Pregnancy and breastfeeding (will be perform pregnancy test to females after menarche). 11. Adrenalin-contraindicated patients (high blood pressure). 12. Patients who, at least one year before the study, were under non-conventional treatments such as: Vimang, Aloe, ozone, banana capsules. | + | 1. Patients on allergenic extract immunotherapy during the two years before.
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| + | 2. Patients classified as intermittent or severe persistent asthmatics after being interviewed.
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| + | 3. Patients with a diagnostic of an autoimmune disease.
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| + | 4. Generalized severe eczema.
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| + | 5. Patients with diagnosed tumoral disease.
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| + | 6. Patients on betablocker treatment.
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| + | 7. Patients with psychiatric disorders.
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| + | 8. Patients not cooperating with treatment.
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| + | 9. Patients who needed,at least a year before the study, immunostimulant or immunosuppressor treatment (no corticosteroids) including interferon and cyclosporine A.
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| + | 10. Pregnancy and breastfeeding (will be perform pregnancy test to females after menarche).
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| + | 11. Adrenalin-contraindicated patients (high blood pressure).
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| + | 12. Patients who, at least one year before the study, were under non-conventional treatments such as: Vimang, Aloe, ozone, banana capsules. | ||
| Cambios a Final enrolment number | |||
| - | + | 27/12/2018 | |
| Cambios a First Name | |||
| - | Mary | + | Rafaela |
| Cambios a Middle Name | |||
| - | Carmen | + | |
| Cambios a Last Name | |||
| - | Reyes Zamora | + | Andina Corrales |
| Cambios a Specialty | |||
| - | IGM and Immunology | + | Specialist 1st Degree in Allergology |
| Cambios a Affiliation | |||
| - | National Center of Bioproducts (BIOCEN), Allergen Department | + | Juan Manuel Marquez Pediatric Hospital |
| Cambios a Postal Address | |||
| - | Carretera de Beltrán Km 1 ½, | + | ave 31 esq 76, Marianao |
| Cambios a City | |||
| - | Bejucal, Mayabeque | + | Havana |
| Cambios a Zip Code | |||
| - | CP 13050, Box 6048 | + | 11400 |
| Cambios a Telephone | |||
| - | 53-047-066-82201 - 07, ext: 2100, 2101 y 2102. | + | 72609651 |
| Cambios a First Name | |||
| - | Raúl | + | Mary |
| Cambios a Middle Name | |||
| - | Lázaro | + | Carmen |
| Cambios a Last Name | |||
| - | Castro Almarales | + | Reyes Zamora |
| Cambios a Specialty | |||
| - | IGM and Allergy | + | Frist Degree Specialist in Immunology, Master in Clinical Trials |
| Cambios a Affiliation | |||
| - | National Center of Bioproducts (BIOCEN), Allergen Deparment | + | National Center of Bioproducts (BIOCEN), Group of Clinical Trials. |
| Cambios a Postal Address | |||
| - | Carretera de Beltrán Km 1 ½ | + | Carretera de Beltrán Km 1 ½, Bejucal |
| Cambios a City | |||
| - | Bejucal, Mayabeque | + | Mayabeque |
| Cambios a Zip Code | |||
| - | CP 13050, Box 6048 | + | 32600 |
| Cambios a Telephone | |||
| - | 53-047-066-82201 - 07, ext: 2100, 2101 y 2102. | + | +53 47 682201-07 ext 1145 and 1147 |
| Cambios a Record Verification Date | |||
| - | 2012-03-30 20:00 | + | 2022/10/14 |
| Cambios a Next update date | |||
| - | + | 2023/10/14 | |
| Cambios a Acronym of Public Title | |||
| - | + | SLIT VALERGEN-Asthma-Children-Phase II | |
| Cambios a Scientific title | |||
| - | Therapeutic effect and security of the sublingual vaccines of house-dust mites, with different posologicals regimens in asthmatic children sensitive to those mites (Version 1). | + | Therapeutic effect and safety of the sublingual vaccines of house-dust mites with different treatment schedules in asthmatic children sensitive to those mites (Version 1.3). |
| Cambios a Acronym of Scientific Title | |||
| - | + | SLIT VALERGEN-Asthma-Children-Phase II | |
| Cambios a Secondary indentifying numbers | |||
| - | DA-EC2012012 | + | GEC2012DPBT016 |
| Cambios a Source(s) of monetary or material support | |||
| - | National Center of Bioproducts (BioCen) | + | National Center of Bioproducts (BioCen)Cuban Ministry of Public Health |
Revisión de 14 Octubre 2022 - 9:35am