- Trials with a EudraCT protocol (482)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
482 result(s) found for: Process safety.
Displaying page 1 of 25.
EudraCT Number: 2004-005023-18 | Sponsor Protocol Number: V232-054-00 | Start Date*: 2005-06-09 | |||||||||||
Sponsor Name:Merck Sharp & Dohme (Sweden) AB | |||||||||||||
Full Title: Study in Healthy Young Adults to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade | |||||||||||||
Medical condition: Acute hepatitis B without delta-agent and without hepatic coma | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Completed) FI (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2005-002578-31 | Sponsor Protocol Number: X05-AR21-302 | Start Date*: 2005-09-14 |
Sponsor Name:Sanofi Pasteur MSD S.N.C. | ||
Full Title: A controlled, double-blind and randomized study, to compare the immunogenicity and safety of HEXAVAC manufactured by an upgraded process to HEXAVAC manufactured by the current process when given to... | ||
Medical condition: The vaccine is indicated for primary and booster vaccination of children against six infectious diseases: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis caused by 3 types of poliovirus ... | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: SK (Ongoing) CZ (Prematurely Ended) | ||
Trial results: (No results available) |
EudraCT Number: 2005-002789-12 | Sponsor Protocol Number: U05-PnPS-403 | Start Date*: 2005-09-28 |
Sponsor Name:Sanofi Pasteur MSD S.N.C | ||
Full Title: A double blind comparative and randomised study in healthy adults of the safety, tolerability, and immunogenicity of PNEUMOVAX®II formulated with either all new process polysaccharides or all curre... | ||
Medical condition: Prevention of invasive pneumococcal disease (IPD) | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male, Female | |
Trial protocol: GB (Completed) | ||
Trial results: View results |
EudraCT Number: 2006-003648-46 | Sponsor Protocol Number: V121-019-00 | Start Date*: 2007-03-12 |
Sponsor Name:Merck & Co. Inc. | ||
Full Title: A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process | ||
Medical condition: Hepatitis-B infection | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: FI (Completed) | ||
Trial results: View results |
EudraCT Number: 2006-001638-42 | Sponsor Protocol Number: 057-00 | Start Date*: 2006-09-22 | |||||||||||
Sponsor Name:MSD (Norge) AS | |||||||||||||
Full Title: Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and ... | |||||||||||||
Medical condition: Hepatitis B | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: NO (Completed) FI (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-001444-35 | Sponsor Protocol Number: V210-063 | Start Date*: 2017-04-07 | |||||||||||
Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | |||||||||||||
Full Title: A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly with M-M-R™ II | |||||||||||||
Medical condition: Active immunization for the prevention of varicella in individuals 12 months of age and older | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-003981-15 | Sponsor Protocol Number: V232-056 | Start Date*: 2016-09-30 | |||||||||||
Sponsor Name:Merck & Co., Inc. | |||||||||||||
Full Title: A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process | |||||||||||||
Medical condition: Hepatitis B | |||||||||||||
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Population Age: Newborns, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2006-003649-18 | Sponsor Protocol Number: V232-059-00 | Start Date*: 2007-01-12 | |||||||||||
Sponsor Name:Merck & Co. Inc. | |||||||||||||
Full Title: A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process | |||||||||||||
Medical condition: Hepatitis B | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Completed) GB (Completed) DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-001910-27 | Sponsor Protocol Number: V210-A03 | Start Date*: 2019-07-02 | |||||||||||
Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc | |||||||||||||
Full Title: A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process Administered Concomitantl... | |||||||||||||
Medical condition: Prevention of varicella in individuals 12 months of age and older | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-001476-63 | Sponsor Protocol Number: 2014-001476-63 | Start Date*: 2023-05-05 |
Sponsor Name:CELLPROTHERA S.A.S | ||
Full Title: A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process, and injected ... | ||
Medical condition: Severe acute myocardial Infarction. Indication : Injection of in vitro expanded peripheral blood CD34+ stem cells output by the StempXpand Automated Process, in patients with an acute myocardial in... | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male, Female | |
Trial protocol: SI (Completed) | ||
Trial results: (No results available) |
EudraCT Number: 2006-003650-20 | Sponsor Protocol Number: V232-060-02 | Start Date*: 2007-02-19 | |||||||||||
Sponsor Name:Merck & Co Inc., | |||||||||||||
Full Title: A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured with a Modified Process | |||||||||||||
Medical condition: Hepatitis B | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) ES (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2009-017781-23 | Sponsor Protocol Number: 720903 | Start Date*: 2010-01-18 | |||||||||||
Sponsor Name:Baxter Innovations GmbH | |||||||||||||
Full Title: An Open Label Phase 3 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult Population | |||||||||||||
Medical condition: To verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season, manufactured according to the ... | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: BE (Completed) AT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2008-004764-39 | Sponsor Protocol Number: CTBM100C2303E1 | Start Date*: 2009-09-07 | |||||||||||
Sponsor Name:Novartis Pharma Services AG | |||||||||||||
Full Title: A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Comp... | |||||||||||||
Medical condition: Pseudomonas aeruginosa infection in cystic fibrosis patients | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: LT (Completed) LV (Completed) EE (Completed) BG (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2008-002318-22 | Sponsor Protocol Number: CTBM100C2303 | Start Date*: 2009-09-07 | |||||||||||
Sponsor Name:Novartis Pharma Services AG | |||||||||||||
Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a ... | |||||||||||||
Medical condition: Pseudomonas aeruginosa infection in cystic fibrosis patients | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: LT (Completed) LV (Completed) EE (Completed) BG (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2009-016734-26 | Sponsor Protocol Number: CTBM100C2303E2 | Start Date*: 2010-01-08 | |||||||||||
Sponsor Name:Novartis Pharma Services AG | |||||||||||||
Full Title: A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who succ... | |||||||||||||
Medical condition: Pseudomonas aeruginosa infection in cystic fibrosis patients | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: EE (Completed) LV (Completed) LT (Completed) BG (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-002048-18 | Sponsor Protocol Number: 16/195 | Start Date*: 2016-11-21 |
Sponsor Name:UNIVERSIDAD REY JUAN CARLOS | ||
Full Title: Clinical Trial to determine efficacy and safety of healing with platelet-rich plasma, fibrin and leukocytes compared to standard healing with nitrofurazone ointment in subjects with onychocryptosis. | ||
Medical condition: THE POST-OPERATIVE OF NAIL SURGERY WITH PHENOL 88% TECHNIQUE IN SUBJECTS WITH ONYCOCRYPTOSIS IN BOTH FIRST TOES HEALINGS WITH NITROFURAZONE OINTMENT OR LEUCOYTES, FIBRINE AND PLATELETS PLASMA CLOT. | ||
Disease: | ||
Population Age: Adults | Gender: Male, Female | |
Trial protocol: ES (Completed) | ||
Trial results: View results |
EudraCT Number: 2006-001639-23 | Sponsor Protocol Number: V232-058 | Start Date*: 2006-09-05 | |||||||||||
Sponsor Name:Merck SHARP & DOHME DE ESPAÑA | |||||||||||||
Full Title: A Study to Assess the Anamnestic Immune Response 4 to 6 Years After a Primary Vaccination Series With HBVAXPRO™ Estudio para evaluar la respuesta inmune anamnésica 4 a 6 años después de una pauta d... | |||||||||||||
Medical condition: Hepatitis B | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2015-005792-25 | Sponsor Protocol Number: R04341 | Start Date*: 2017-12-22 | ||||||||||||||||||||||||||
Sponsor Name:Manchester University NHS Foundation Trust | ||||||||||||||||||||||||||||
Full Title: Feasibility study on the effects of L-citrulline on uteroplacental and cardiovascular function in hypertensive pregnant women | ||||||||||||||||||||||||||||
Medical condition: The medical condition that is to be investigated in this study is essential hypertension in pregnant women. In this study it is defined as diastolic BP of ≥90 mmHg (average of two clinic readings) ... | ||||||||||||||||||||||||||||
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Population Age: Adults | Gender: Female | |||||||||||||||||||||||||||
Trial protocol: GB (Completed) | ||||||||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2015-005327-63 | Sponsor Protocol Number: NN7088-4033 | Start Date*: 2016-12-08 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A multi-centre, comparative, double blind, randomised cross-over trial investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pe... | |||||||||||||
Medical condition: Haemophilia A | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: NL (Completed) DK (Completed) DE (Completed) ES (Completed) FR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-004441-32 | Sponsor Protocol Number: MSV-crio | Start Date*: 2013-03-06 | |||||||||||
Sponsor Name:Fundación Teknon | |||||||||||||
Full Title: Pilot clinical trial to determine the feasibility and safety of MSV * cryopreserved in the treatment of gonartrosis. * MSV = mesenchymal progenitor cells of expanded autologous bone marrow with GMP... | |||||||||||||
Medical condition: Patients diagnosed with gonarthrosis II, III and IV degrees of Kellgren and Lawrence | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Completed) | |||||||||||||
Trial results: (No results available) |
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