Clinical trials: Enterovirus Infections
Enterovirus Infections
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 6 to 35 Months Old
The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant AlPO4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children…
- Trial name
- NCT02777411
- Testing
- EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose), EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose), EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)
- Where
- 4 sites in Taiwan
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Enimmune Corporation
Diphtheria, Tetanus
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00654901
- Testing
- DTaP-IPV-Hep B-PRP~T vaccine (Batch 1), DTaP-IPV-Hep B-PRP~T vaccine (Batch 2), DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
- Where
- 4 sites in Mexico
- Volunteers
- 881 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Hepatitis A
Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years
To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.
- Trial name
- NCT00197119
- Testing
- Twinrix™ Adult, Twinrix™ Junior
- Where
- 2 sites in Belgium, Czechia
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hand, Foot and Mouth Disease
Efficacy Trial of a Commercial EV71 Vaccine
The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine post marketing, and explore the protective levels of various enterovirus neutralizing antibodies
- Trial name
- NCT03903926
- Testing
- 5000 volunteers (6-35 months)-EV71 vaccine
- Where
- 2 sites in China
- Volunteers
- 15,500 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Hepatitis A
Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug".
- Trial name
- NCT01838070
- Where
- South Korea
- Volunteers
- 614 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Acellular Pertussis, Tetanus
Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age
The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine.
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria, Hepatitis B
- Trial name
- NCT00376779
- Testing
- Infanrix hexa Vaccine
- Where
- 6 sites in Finland
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Acellular Pertussis
Evaluation of Immunogenicity and Safety of DTPa-IPV/Hib Conjugate Vaccine (Infanrix™-IPV/Hib) Administered at 6, 10 and 14 Weeks in Healthy Indian Infants
The purpose of this study is to assess the immunogenicity and safety of DTPa-IPV/Hib when administered at 6, 10 and 14 weeks to healthy Indian infants, as per guidance from the Indian regulatory authority.
- Conditions
- Diphtheria, Acellular Pertussis, Haemophilus Influenzae Type b, Tetanus
- Trial name
- NCT03128489
- Testing
- Infanrix-IPV/Hib
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Acellular Pertussis
Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines
The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal…
- Conditions
- Hepatitis B, Acellular Pertussis, Tetanus, Poliomyelitis
- Trial name
- NCT00463437
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Prevenar, Infanrix hexa
- Where
- 63 sites in Germany, Poland and 1 more
- Volunteers
- 1,437 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Polio
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00401531
- Testing
- DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines, DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
- Where
- 2 sites in Thailand
- Volunteers
- 412 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis A
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants between 6-12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae.
- Trial name
- NCT00338351
- Testing
- Pneumococcal (vaccine)
- Where
- Chile
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Enterovirus Infections
Extension Study of Protocol EV-BR1701 Group B1
The main study was a randomized, multi-nation, multi-centered, double-blinded, phase III study on subjects aged 2 months to <6 years old (<72 months). Two parts were conducted in Taiwan (Group A) and Vietnam (Group B).
- Trial name
- NCT07630493
- Where
- Vietnam
- Volunteers
- 126 people
- Sponsor
- Enimmune Corporation
Poliomyelitis, Tetanus
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
This study will evaluate the immunogenicity of the co-administration of different combinations of DTPa, IPV, hepatitis B, Hib and Men C vaccines during the first year of life.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Hepatitis B
- Trial name
- NCT00352963
- Testing
- Study vaccines: IH+Hib-MenC/NVC; Control: IH+Meningitec
- Where
- 22 sites in Spain
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in…
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio
- Trial name
- NCT01491087
- Testing
- DTacP IPV//PRP~T combined vaccine: PENTAXIM®
- Where
- 3 sites in China
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis C Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks…
- Trial name
- NCT01701401
- Testing
- LDV/SOF, RBV
- Where
- 88 sites in United States, France and 5 more
- Volunteers
- 870 people
- Sponsor
- Gilead Sciences
Poliomyelitis
Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine
The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and…
- Trial name
- NCT04386707
- Testing
- Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age, Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age, Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
- Where
- 4 sites in China
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Hepatitis B, Hepatitis A
Evaluation of the Long-term Hepatitis A and B Antibody Persistence in Healthy Adult Subjects, Primed 16 to 20 Years Earlier With GSK Biologicals' Combined Hepatitis A and B Vaccine, Twinrix® (SB208127) in Study HAB-084 (208127/084)
The purpose of this study is to assess the long-term persistence of immunity to hepatitis A and B in adults who were vaccinated 16-20 years earlier with the combined hepatitis A and hepatitis B vaccine, Twinrix.
- Trial name
- NCT02135666
- Testing
- Blood sampling
- Where
- Czechia
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Hepatitis A
Long-term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Mth Schedule in Healthy Adults
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 after subjects received their first dose of a 3 dose primary vaccination schedule of combined hepatitis…
- Trial name
- NCT00289770
- Testing
- Twinrix™
- Where
- Belgium
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines. Stage I Primary Objectives: 1.
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Polio
- Trial name
- NCT00662870
- Testing
- DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine), Pentacel: DTaP-IPV/Hib
- Where
- 26 sites in United States
- Volunteers
- 1,941 people, healthy volunteers welcome
- Sponsor
- Sanofi
Chronic Hepatitis C Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) administered for 8 or 12 weeks in treatment-naive…
- Trial name
- NCT01851330
- Testing
- LDV/SOF, RBV
- Where
- 52 sites in United States
- Volunteers
- 647 people
- Sponsor
- Gilead Sciences
Poliomyelitis
An Immunogenicity and Safety Study of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.
- Trial name
- NCT03526978
- Testing
- Investigational sIPV, Control IPV
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd