View clinical trials related to Diphtheria.
Filter by:The aim of the study is to generate additional safety and immunogenicity data to support the registration of the product in Japan. Primary objectives: - To demonstrate the non-inferiority of SP306 versus DT (DT BIK® 0.1mL) vaccine in terms of diphtheria and tetanus booster response rate (proportion of subjects with booster responses) and seroprotection rate (percentage of subjects with antitoxin concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age. - To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in terms of booster response rate (proportion of subjects with booster responses) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age. Secondary objectives: - To further evaluate the immune response of the study vaccines against diphtheria, tetanus and pertussis antigens. - To assess the safety of the study vaccines after one injection in Japanese adolescents 11-12 years of age.
Primary objective: - To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) and Hepatitis B vaccine administered concurrently in adolescents 11-14 years of age. Secondary objective: - To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at 11-14 years of age results in detectable immunologic interactions between components of the two vaccines.
The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in participants in China. Primary objective: - To describe diphtheria and tetanus seroprotection rates and pertussis booster response rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups), local DT vaccine (in children), and local Td vaccine (in adolescents and adults). Secondary Objectives: - To further describe in each group the immunogenicity of the study vaccines at baseline and 1 month after vaccination. - To describe the safety of the study vaccines
This study will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old children. Data that are available globally on the age group from four to six years of age will be used to bridge the age gap in this study and aid in the registration of the vaccine for children from the age of four years.
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722) and booster vaccination in Study A3L27 (NCT01444781). Study Objective: - To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a 3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) +Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix hexa™+Prevenar™ (PCV7) at 12 to 24 months of age. Observational Objectives: - To describe the long-term antibody persistence by group and by stratification on the age at inclusion of the A3L27 booster study. - To describe the effect of one additional oral dose of stand alone poliovirus isotypes 1, 2 and 3 vaccine* on the antibody persistence immune response for poliovirus isotypes (4 vs 5 doses of poliovirus administered).
The purpose of this study is to describe the immunogenicity and safety of a novel DTaP- IPV- Hep B-PRT~T fully liquid combined hexavalent vaccine (Hexaxim™) administered at 6, 10 and 14 weeks of age in infants born to mothers documented to be serum anti-hepatitis B surface antigen (HBsAg) serology negative in India. Primary Objective: - To evaluate the immunogenicity of the study vaccine in terms of seroprotection [diphtheria toxoid, tetanus toxoid, poliovirus types 1, 2 and 3, Haemophilus influenzae type b (Hib) polysaccharide (PRP), hepatitis B (Hep B)] and vaccine response for pertussis antigens [pertussis toxoid (PT) and filamentous haemagglutinin (FHA)] one month after the third dose. Secondary Objectives: - To further describe the immunogenicity of the study vaccine, before the first dose and one month after the third dose. - To describe the safety after each and any doses of the study vaccine.
The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of participants in China. Primary objective: - To describe the safety in terms of occurrence of serious adverse reactions and grade 3 adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children. Secondary objective: - To describe the full reactogenicity profile after administration of sanofi pasteur's Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.
The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with staggered administration of RotaTeq™.
This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.