Pneumococcal polysaccharide vaccine ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎3
46悪性関節リウマチ5
222一次性ネフローゼ症候群1

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05028634
(ClinicalTrials.gov)
October 27, 202125/8/2021Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-ß or No Disease Modifying TherapyA Phase 3b, Multicenter, Open-Label Study to Evaluate the Immune Response to, and the Safety of, Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Oral Ozanimod Compared to Non-Pegylated Interferon (IFN)-ß or No Disease Modifying TherapyMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingBiological: Tetanus, diphtheria, and acellular pertussis vaccine;Biological: Pneumococcal polysaccharide vaccine;Biological: Seasonal influenza vaccineCelgeneNULLRecruiting18 Years55 YearsAll60Phase 3United States;Germany
2NCT03650114
(ClinicalTrials.gov)
November 22, 201817/8/2018Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MSAn Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisBiological: Ofatumumab;Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap);Biological: 13-valent pneumococcal conjugate vaccine (13-PCV);Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV);Biological: Seasonal Quadrivalent influenza vaccine;Biological: Keyhole limpet hemocyanin (KLH) neo-antigenNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll2010Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;India;Israel;Japan;Latvia;Lithuania;Mexico;Netherlands;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom
3NCT02097849
(ClinicalTrials.gov)
February 28, 201525/3/2014Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.An Open-Label Study to Assess the Immune Response to Vaccination in Tecfidera® (BG00012)-Treated Versus Interferon-Treated Subjects With Relapsing Forms of Multiple Sclerosis.Relapsing Forms of Multiple SclerosisDrug: dimethyl fumarate;Biological: tetanus diphtheria toxoids vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent);Drug: non-pegylated interferonBiogenNULLCompleted18 Years55 YearsAll71Phase 2United States

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03762824
(ClinicalTrials.gov)
June 14, 20163/12/2018Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic DiseaseCombined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;SpondyloarthritisBiological: 13-valent pneumococcal conjugate vaccine;Biological: 23-valent pneumococcal polysaccharide vaccineRegion SkaneNULLCompleted18 YearsN/AAll300Phase 4NULL
2NCT02547493
(ClinicalTrials.gov)
March 3, 20167/9/2015Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis PatientsComparison of Humoral Response to Conjugate Pneumococcal Vaccine and Polysaccharide Pneumococcal Vaccine in Rheumatoid Arthritis (RA) Patients Treated With AbataceptRheumatoid ArthritisBiological: pneumococcal polysaccharide vaccine;Biological: pneumococcal conjugate vaccine;Drug: AbataceptUniversity Hospital, MontpellierBristol-Myers SquibbCompleted18 Years85 YearsAll80N/AFrance;Monaco
3EUCTR2014-001299-79-DK
(EUCTR)
06/10/201407/07/2014Pnemococcal vaccination of rheumatoid arthritis patients in biological treatmentPneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy - Immunovax_RA Immunoresponse on pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapy
MedDRA version: 18.0;Level: LLT;Classification code 10069594;Term: Pneumococcal immunization;System Organ Class: 100000004865;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Prevenar 13
INN or Proposed INN: pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM197 CARRIER PROTEIN AND ADSORBED ON ALUMINIUM PHOSPHATE
Trade Name: Pneumovax
INN or Proposed INN: pneumococcal polysaccharide serotype 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT)
Department of Infectious Diseases, Odense University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 3Denmark
4NCT01163747
(ClinicalTrials.gov)
September 201014/7/2010A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background MethotrexateRheumatoid ArthritisBiological: tocilizumab;Drug: methotrexate;Biological: 23-Valent Pneumococcal Polysaccharide Vaccine;Biological: Tetanus Toxoid Adsorbed VaccineGenentech, Inc.NULLCompleted18 Years64 YearsAll91Phase 4United States
5NCT00282308
(ClinicalTrials.gov)
January 23, 200624/1/2006A Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background MethotrexateA Phase II, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Rituximab on Immune Responses in Subjects With Active Rheumatoid Arthritis Receiving Background MethotrexateRheumatoid ArthritisDrug: Rituximab;Drug: Methotrexate;Drug: Methylprednisone;Biological: C. albicans;Biological: Tetanus toxoid adsorbed booster vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine;Biological: Keyhole limpet hemocyaninGenentech, Inc.NULLCompleted18 Years65 YearsAll103Phase 2United States

222. 一次性ネフローゼ症候群


臨床試験数 : 285 薬物数 : 285 - (DrugBank : 108) / 標的遺伝子数 : 62 - 標的パスウェイ数 : 191
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-002637-15-IT
(EUCTR)
09/04/202104/06/2021Phase 2, multicenter, open-label, randomized, controlled study is designed to evaluate the safety and efficacy of APL-2 in patients who have post-transplant recurrence of C3G or IC-MPGNAn Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrenceof C3G or IC-MPGN - NOBLE complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)
MedDRA version: 20.1;Level: LLT;Classification code 10063210;Term: Transplant glomerulopathy;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Pegcetacoplan
Product Code: [APL-2]
INN or Proposed INN: Pegcetacoplan
Trade Name: Prevenar 13 suspension for injection
Product Name: Prevenar 13 suspension for injection
Product Code: [na]
INN or Proposed INN: Pneumococcal polysaccharide serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F
Other descriptive name: Pneumococcal polysaccharide serotype 11 2.2 µg
Trade Name: Pneumococcal polysaccharide vaccine
Product Name: Pneumococcal polysaccharide vaccine solution for injection in a vial
Product Code: [na]
INN or Proposed INN: Pneumococcal Polysaccharide Vaccine
Other descriptive name: The 0.5 mL dose of vaccine contains 25 micrograms of each of the following 23 pneumococcal polysaccharide
APELLIS PHARMACEUTCIALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2France;Argentina;Spain;Brazil;Austria;Australia;Netherlands;United Kingdom;Switzerland;Italy;United States