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Active clinical trials for "Tetanus"

Results 21-30 of 164

Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

TetanusDiphtheria2 more

The aim of this study is to describe immunogenicity of a single booster dose of Adacel vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age. Primary objective: To describe seroprotection rates against tetanus and diphtheria in subjects randomized to receive either Adacel or Boostrix vaccine. Observational objectives: To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean antibody concentrations (GMCs) in subjects randomized to receive either Adacel or Boostrix vaccine. To describe booster response rates against tetanus, diphtheria, and pertussis in subjects randomized to receive either Adacel or Boostrix vaccine. To describe the rates of adverse events (AEs) immediately post-vaccination, and the rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with Adacel or Boostrix vaccine from Visit 1 through Visit 2.

Completed23 enrollment criteria

Study of Tetanus and Diphtheria Toxoids Adsorbed Combined With Component Pertussis Vaccine and Inactivated...

PertussisTetanus3 more

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.

Completed17 enrollment criteria

Comparative Study of Two Tetanus Toxoid Vaccination Strategies: Cold Chain Versus Controlled Temperature...

TetanusTetanus Vaccine

The purpose of this study is to determine the effectiveness, safety and feasibility of a tetanus toxoid (TT) vaccination strategy relying on the maintenance of vaccines in a controlled temperature chain (CTC). The CTC is defined as the storage and transport of vaccines within a temperature range appropriate to the heat stability profile of TT vaccine. In this study vaccines are transported and stored in the cold chain up to district level. From district to beneficiary level vaccines are exposed to ambient temperatures during a limited period of time. In an initial phase, the stability of 3 lots of TT vaccine kept in CTC is determined. For this, the potency, safety, pH and adsorption of vaccines maintained in CTC will be tested in the laboratory and compared to vaccines that have been maintained in cold chain. If all parameters (i.e. potency, safety, pH and adsorption) are above WHO specifications the strategy in CTC will be used. Only if the laboratory results are adequate, villages will be assigned to one of the vaccination strategies. All women between 14 to 49 years of age in the selected villages who fulfill the inclusion criteria will be invited to participate. In order to determine the baseline anti-tetanus protection, TT vaccination history will be collected from all participants using a standardized questionnaire. Women who have already received at least 2 doses of TT vaccine will be excluded from the study. Moreover, blood will be collected from all participants to later verify in laboratory the baseline protection. A first dose of TT vaccine will be given according to the assigned strategy (CTC or cold chain). Four weeks after the 1st vaccination, a second TT vaccine will be given using the same strategy employed for the first dose. Finally, four weeks after the second dose, a blood sample will be collected from all participants who received two doses of vaccine. The serological responses will be compared in the group that received two doses of TT vaccine maintained in cold chain ant the group that received two doses of vaccine maintained in CTC.

Completed11 enrollment criteria

Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers

Acellular PertussisHaemophilus Influenzae Type b4 more

This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.

Completed16 enrollment criteria

DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in...

DiphtheriaTetanus4 more

The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's DTaP-IPV//PRP~T combined vaccine (Pentaxim™) given at 2, 4, and 6 months of age and Hep B vaccine (Euvax B®) given at 1 and 6 months of age in South Korean infants that received a birth dose of Hep B and born to mothers documented to be serum anti-HBs Ag negative. Primary Objective To demonstrate the non-inferiority in terms of seroprotection (Diphtheria, Tetanus, poliovirus types 1, 2, and 3, PRP-T, Hep B) and vaccine response for pertussis antigens (pertussis toxoid [PT] and filamentous haemagglutinin [FHA]) of Group A versus Group B, one month after the third dose of combined vaccines. Secondary Objectives: To further study the immunogenicity of the two vaccination schemes, before the first dose and one month after the last dose of vaccines. To study the safety after each and any dose of vaccines administered in the two vaccination schemes

Completed21 enrollment criteria

Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis...

DiphtheriaTetanus2 more

Primary objective: To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects Secondary objectives: If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years To describe the immune responses to REPEVAX in these subjects To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects

Completed12 enrollment criteria

REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children

DiphtheriaTetanus1 more

Primary objective: To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children . Secondary objectives: Additional immunogenicity assessments. To describe the safety profile of a single dose of REVAXIS® or DT-Polio®

Completed14 enrollment criteria

Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine...

DiphtheriaTetanus3 more

DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance. Primary Objectives: To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth. To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth. Secondary Objective: To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).

Completed17 enrollment criteria

Immunogenicity and Safety of Tetanus, Diphtheria and Mono Component Acellular Pertussis (TdaP) Vaccine...

Healthy

The clinical trial is a phase III, double-blind, randomised, controlled, multi-centre, clinical trial, on the immunogenicity and safety of TdaP vaccine in comparison to Td vaccine when given as a booster vaccination to adults who were vaccinated with D, T and wP vaccine according to the Danish vaccination programme in their childhood. Healthy, adult, female or male volunteers, who completed primary vaccination with diphtheria (D), tetanus (T) and whole cell pertussis vaccine (wP), typically during their childhood, is the target population.

Completed16 enrollment criteria

Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With...

DiphtheriaTetanus3 more

Objectives: To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine. To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.

Completed21 enrollment criteria
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