Clinical trials: sponsored by Sanofi
Hemophilia A
An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A.
- Trial name
- NCT02234323
- Testing
- rFVIIIFc
- Where
- 71 sites in United States, Australia and 12 more
- Volunteers
- 108 people
- Sponsor
- Bioverativ, a Sanofi company
Type 1 Diabetes Mellitus
Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)
Primary Objective: To evaluate the effect of virtual approach via novel technologies versus traditional study conduct on glycemic control in terms of glycated hemoglobin (HbA1c).
- Trial name
- NCT03260868
- Testing
- Insulin glargine, 300 units per milliliter (U/mL), Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)
- Where
- 6 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- Sanofi
Influenza
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
This randomized, modified double-blind, active-controlled, multi-center trial assessed the safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared to either the licensed or investigational…
- Trial name
- NCT03282240
- Testing
- QIV-HD, Licensed TIV-HD1, Investigational TIV-HD2
- Where
- 36 sites in United States
- Volunteers
- 2,670 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pompe Disease, Glycogen Storage Disease Type II (GSD-II)
Immune Tolerance Induction Study
An exploratory, open-labeled study of participants with Pompe disease, who had previously received Myozyme® (alglucosidase alfa) treatment, to evaluate the efficacy, safety and clinical benefit of 2 Immune Tolerance Induction…
- Conditions
- Pompe Disease, Glycogen Storage Disease Type II (GSD-II), Glycogenesis 2 Acid Maltase Deficiency
- Trial name
- NCT00701701
- Testing
- Myozyme® (alglucosidase alfa)
- Where
- 5 sites in United States, Israel
- Volunteers
- 4 people
- Sponsor
- Genzyme, a Sanofi Company
Hepatitis B
Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine.
The aim of the study is to assess the persistence of anti-Hep B antibody at 9 to 10 years of age after the last priming dose in subjects who completed study A3L12 (NCT00401531), and also evaluate the immune response against…
- Trial name
- NCT02697474
- Testing
- Euvax B®: Hepatitis B vaccine
- Where
- 2 sites in Thailand
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza
Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok
The purpose of this study was to evaluate a single dose of FluBlok in terms of safety, efficacy and effectiveness in prevention of influenza and influenza-like illness and assess clinical lot-to-lot consistency in manufacturing…
- Trial name
- NCT00539981
- Testing
- FluBlok®
- Where
- 24 sites in United States
- Volunteers
- 4,648 people, healthy volunteers welcome
- Sponsor
- Sanofi
Meningococcal Infections
Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children
This was an open-label, multi-center study to describe the immune persistence of the priming dose and describe the immunogenicity and safety of a booster dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus…
- Trial name
- NCT03476135
- Testing
- MenACYW conjugate vaccine
- Where
- 8 sites in Finland
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Dengue, Dengue Fever
Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India
The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects. Primary Objectives: To describe the neutralizing antibody response to each dengue virus serotype before the…
- Conditions
- Dengue, Dengue Fever, Dengue Hemorrhagic Fever
- Trial name
- NCT01550289
- Testing
- Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
- Where
- 5 sites in India
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth
The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months…
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT02428491
- Testing
- Hexaxim®
- Where
- Vietnam
- Volunteers
- 354 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Dengue Virus, Dengue Fever
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
This trial evaluated the use of a tetravalent vaccine against dengue. Primary objectives: To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents…
- Conditions
- Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Disease
- Trial name
- NCT00875524
- Testing
- CYD dengue vaccine serotypes (1, 2, 3, 4)., Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
- Where
- Vietnam
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02752906
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- 30 sites in United States, Puerto Rico
- Volunteers
- 810 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older
The aim of the study was to demonstrate non-inferiority of immunogenicity and evaluate the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid conjugate vaccine (MenACYW conjugate…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02842866
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 907 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Dengue Virus, Dengue Fever
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease. Primary Objectives: To describe the humoral immune response to dengue before and after each vaccination with…
- Conditions
- Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
- Trial name
- NCT00788151
- Testing
- CYD Dengue Vaccine Serotypes 1, 2, 3, and 4, Pneumococcal polysaccharide vaccine
- Where
- Peru
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
This study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02817451
- Testing
- Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
- Where
- South Africa
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Toddlers
The purpose of the study was to evaluate the immunogenicity and describe the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02955797
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine
- Where
- 33 sites in Finland, Germany and 2 more
- Volunteers
- 918 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal
Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers
This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study was conducted to assess the immunogenicity and safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W)…
- Trial name
- NCT03205371
- Testing
- MenACYW conjugate vaccine, MMR, Varicella
- Where
- 37 sites in Mexico, Russia and 2 more
- Volunteers
- 1,183 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal Meningitis
Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
The purpose of the study was to evaluate immune lot consistency of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine and the immune non-inferiority compared to the licensed vaccine…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02842853
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- 89 sites in United States
- Volunteers
- 3,344 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Dengue Virus, Dengue Fever
Efficacy and Safety of Dengue Vaccine in Healthy Children
The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four…
- Conditions
- Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
- Trial name
- NCT00842530
- Testing
- CYD Dengue Vaccine, Inactivated rabies virus vaccine
- Where
- Thailand
- Volunteers
- 4,002 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Influenza
Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age
The objectives of this study were: To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including…
- Trial name
- QHD04 (NCT03698279)
- Testing
- High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated), High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated), High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)
- Where
- 16 sites in United States, Canada
- Volunteers
- 665 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02199691
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 1,715 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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