Clinical trials: Safety Issues
Safety Issues, Immunogenicity
Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
- Trial name
- NCT03680417
- Testing
- Measles-Rubella (MR) Vaccine
- Where
- Indonesia
- Volunteers
- 590 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I)
This study is to assess the safety of Vi-DT vaccine in adults and children.
- Trial name
- NCT03109600
- Testing
- Vi-DT (Bio Farma), Vi polysaccharide vaccine, Influenzae vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population
This study is to assess protectivity and safety of Quadrivalent Influenza Vaccine in Indonesian Population
- Trial name
- NCT03336593
- Testing
- Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine
- Where
- 3 sites in Indonesia
- Volunteers
- 810 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues, Effect of Drug
ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection
The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection.
- Trial name
- ADC (NCT06342921)
- Testing
- 15 mg ADC189, 45 mg ADC189
- Where
- China
- Volunteers
- 749 people
- Sponsor
- Jiaxing AnDiCon Biotech Co.,Ltd
Safety Issues
Safety Evaluation of Lactobacillus Salivarius AP-32 and Bifidobacterium Animalis Subsp. Lactis CP-9 in Healthy Infants.
This is a three-arm, double-blind, placebo-controlled study to investigate the safety of Lactobacillus salivarius AP-32 and Bifidobacterium animalis subsp. lactis CP-9 used individually in healthy infants.
- Trial name
- NCT04140604
- Testing
- Lactobacillus salivarius AP-32, Bifidobacterium animalis subsp. lactis CP-9
- Where
- Taiwan
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Hsieh-Hsun Ho
Safety Issues, HPV Infection
BS-FU01 Follow-Up Study of FluBHPVE6E7 Study Subjects
This is a follow-up study for patients treated with FluBHPVE6E7 in previous interventional studies.
- Trial name
- NCT04528407
- Testing
- Observation without intervention
- Where
- Austria
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- BlueSky Immunotherapies GmbH
Safety Issues
Safety Analysis of Implantation of Stromal Vascular Fraction
Stromal vascular fraction (SVF) can be isolated from fat (adipose) tissue in an outpatient in-clinic procedure. Platelet rich plasma (PRP) can be isolated from peripheral blood.
- Trial name
- NCT03226093
- Testing
- Stromal Vascular Fraction
- Volunteers
- 676 people
- Sponsor
- Bioheart, Inc.
Safety Issues, Immunogenicity
Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
- Trial name
- NCT04051268
- Testing
- Vi-DT Typhoid Conjugate Vaccine, PQed Typhoid Conjugate Vaccine, Vi Polysaccharide Vaccine
- Where
- Indonesia
- Volunteers
- 3,071 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
- Trial name
- NCT06053853
- Testing
- Diphtheria Antitoxin
- Where
- Indonesia
- Volunteers
- 68 people
- Sponsor
- PT Bio Farma
Safety Issues, Immunogenicity
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
- Trial name
- NCT03460405
- Testing
- Vi-DT Vaccine, Vi Polysaccharide Vaccine, IPV Vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Tolerance of a Probiotic Formula
Evaluate the tolerance of a probiotic formula in infants
- Trial name
- NCT03925558
- Testing
- Probiotics
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Probi AB
Safety Issues
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
- Trial name
- NCT03462108
- Testing
- Rotavirus (Bio Farma) Vaccine
- Where
- 4 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma