Sanofi: Hepatitis B trials

The registry lists 45 Hepatitis B studies with Sanofi as lead sponsor. 0 are open to participants now and 24 have results posted.

Phase 1 4Phase 2 6Phase 3 30No phase 5(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and InfantsCompletedNCT04398706Phase 2Results posted
• HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing HemodialysisCompletedNCT03934736Phase 1Results posted
• Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® VaccineCompletedNCT02117934Phase 3Results posted
• Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at BirthCompletedNCT01948193Phase 3Results posted
• Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy InfantsCompletedNCT01444781Phase 3Results posted
• A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American InfantsCompletedNCT01177722Phase 3Results posted
• Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B VaccineCompletedNCT01005407Phase 3Results posted
• Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) PatientsCompletedNCT00985426Phase 3Results posted
• Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian InfantsCompletedNCT00831753Phase 3Results posted
• Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean InfantsCompletedNCT00831311Phase 2Results posted
• Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™CompletedNCT00654901Phase 3Results posted
• Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish InfantsCompletedNCT00619502Phase 3Results posted
• Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™CompletedNCT00534833Phase 3Results posted
• Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino InfantsCompletedNCT00514709Phase 3Results posted
• Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus VaccineCompletedNCT00511095Phase 2Results posted
• Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® VaccineCompletedNCT00435812Phase 3Results posted
• Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy InfantsCompletedNCT00404651Phase 3Results posted
• Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai InfantsCompletedNCT00401531Phase 3Results posted
• Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPVCompletedNCT00362336Phase 3Results posted
• Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy InfantsCompletedNCT00348881Phase 3Results posted
• Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio VaccineCompletedNCT00343889Phase 3Results posted
• Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months ScheduleCompletedNCT00315055Phase 3Results posted
• Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.CompletedNCT00313911Phase 3Results posted
• Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean InfantsCompletedNCT00303316Phase 3Results posted
• Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of KoreaCompletedNCT06793826
• Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in ThailandCompletedNCT04429295Phase 3
• DV2-HBV-27: Observational Pregnancy RegistryActive, not recruitingNCT03664648
• DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected InfantsCompletedNCT02817451Phase 3
• 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.CompletedNCT02697474Phase 3
• Anti-Hep B Antibodies at Age 12 to 18 Months After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Concomitantly With Prevnar® at 2, 4 and 6 Months of AgeCompletedNCT02610348Not applicable
• 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 BirthCompletedNCT02428491Phase 3
• DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed InfantsCompletedNCT02094833Phase 3
• Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated PoliomyelitisCompletedNCT02040636Phase 2
• Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXACompletedNCT02012998Phase 3
• A Study of the Immune Response to Heplisav in Healthy Older AdultsCompletedNCT01999699Phase 1
• Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa VaccinationCompletedNCT01983540Phase 3
• Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney DiseaseCompletedNCT01282762
• Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on HemodialysisCompletedNCT01195246Phase 3
• Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control VaccineCompletedNCT01105559
• A Study to Assess DV-601 in Subjects With Chronic Hepatitis BCompletedNCT01023230Phase 1
• A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXACompletedNCT00693186Phase 3
• A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal DiseaseTerminatedNCT00498212Phase 2
• Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure PatientsCompletedNCT00426712Phase 1
• Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®CompletedNCT00362427Phase 2
• Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®CompletedNCT00355654Phase 3