View clinical trials related to Diphtheria.
Filter by:The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.
Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal disease caused by Clostridium tetani infection. Currently, there is no clinical trial registration of Diphtheria, tetanus, and pertussis (DPT) vaccine applicable to ≥6 years of age in China, therefore, the five-component acellular DPT combination vaccine developed by our research has a promising future.
This is an open-label Phase Ia/Ib clinical study of tagraxofusp-erzs, a novel cytokine-drug conjugate that links interleukin-3 with a truncated diphtheria toxin, in combination with gemtuzumab ozogamicin for patients with relapsed/refractory AML. The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of tagraxofusp-erzs in combination with gemtuzumab ozogamicin in this patient population. Then, once RP2D is determined, to determine the safety and tolerability of combination gemtuzumab and tagraxofusp-erzs when administered at the RP2D.
The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against diphtheria, tetanus, pertussis, and polio.
The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age.
Pregnancy involves changes in immune response. The investigators aim to evaluate the immune response to Tdap in pregnancy in comparison to non pregnant women usig proteomics and gene sequencing.
Phase III, open, mono-center study in 177 infants who received a dose of Hep B vaccine at birth or within 1 month after birth. Infants will receive Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine (study vaccine) at 2, 3, and 4 months of age. All subjects will provide blood samples for immunogenicity assessment at baseline (pre-vaccination) and at 30 days following the third vaccination. Regarding safety, solicited reactions and unsolicited non-serious adverse events (AEs) will be collected up to 7 days and up to 30 days after each vaccination, respectively. Serious adverse events (SAEs) will be collected throughout the study trial (from Visit 1 to Visit 4)
Vaccines can have non-targeted or heterologous (also called non-specific) immunological effects on the immune system i.e. effects other than inducing an immune response against the disease targeted by the vaccine. This trial aims to evaluate the non-specific immunological effects of two vaccines - diphtheria-tetanus-acellular pertussis (DTP) vaccine and seasonal influenza vaccine - in a cohort of elderly humans (>65 years of age) and healthy adult control subjects (30-50 years).
A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.