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Post Marketing Surveillance for ADACEL™ in South Korea

2014-08-27 03:13:09 | BioPortfolio

Summary

This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".

The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Diphtheria

Intervention

ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined

Location

Jung-gu
Incheon
Korea, Republic of

Status

Recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:09-0400

Clinical Trials [351 Associated Clinical Trials listed on BioPortfolio]

Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration. To des...

A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older

It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have re...

Assessment of the Reactogenicity of ADACEL® (TdcP Vaccine) in Children and Adolescents 7 to 19 Years of Age

To compare the reactogenicity of ADACEL® vaccine given at intervals of 2 to 9 years with the reactogenicity of ADACEL® vaccine given at an interval of 10 or more years following the last...

The Safety and Immunogenicity of Acellular Pertussis Vaccine in Bone Marrow Transplant Recipients

The purpose of this study is to determine if pertussis (whooping cough) vaccine is safe and produces an appropriate immune response against pertussis in blood and marrow transplant patient...

Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose

The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to esta...

PubMed Articles [1495 Associated PubMed Articles listed on BioPortfolio]

Sex-differential effects of diphtheria-tetanus-pertussis vaccine for the outcome of paediatric admissions? A hospital based observational study from Guinea-Bissau.

In spite of protection against the targeted infections, a large volume of observational data indicates that diphtheria-tetanus-pertussis (DTP) vaccine may have a negative impact on overall childhood m...

Immunogenicity and safety of a second booster dose of an acellular pertussis vaccine combined with reduced antigen content diphtheria-tetanus toxoids 10 years after a first booster in adolescence: An open, phase III, non-randomized, multi-center study.

Pertussis is a highly contagious disease, for which periodic peaks in incidence and an increasing number of outbreaks have been observed over the last decades. The reduced-antigen-content tetanus-diph...

Relationship between patient copayments in Medicare Part D and vaccination claim status for herpes zoster and tetanus-diphtheria-acellular pertussis.

To assess the relationship between copay amount and vaccination claim submission status for tetanus-diphtheria-acellular pertussis (Tdap) and herpes zoster (GSK study identifier: HO-14-14319).

Impact of the US Maternal Tetanus, Diphtheria, and Acellular Pertussis Vaccination Program on Preventing Pertussis in Infants <2 Months of Age: A Case-Control Evaluation.

Infants aged

Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose.

Reduced-antigen-content tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is recommended in many countries for boosting immunity in adolescents and adults. Although immunity to these antigen...

Medical and Biotech [MESH] Definitions

A suspension of killed Bordetella pertussis organisms, used for immunization against pertussis (WHOOPING COUGH). It is generally used in a mixture with diphtheria and tetanus toxoids (DTP). There is an acellular pertussis vaccine prepared from the purified antigenic components of Bordetella pertussis, which causes fewer adverse reactions than whole-cell vaccine and, like the whole-cell vaccine, is generally used in a mixture with diphtheria and tetanus toxoids. (From Dorland, 28th ed)

Combined vaccines consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and an acellular form of PERTUSSIS VACCINE. At least five different purified antigens of B. pertussis have been used in various combinations in these vaccines.

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

A vaccine consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and whole-cell PERTUSSIS VACCINE. The vaccine protects against diphtheria, tetanus, and whooping cough.

The formaldehyde-inactivated toxin of Corynebacterium diphtheriae. It is generally used in mixtures with TETANUS TOXOID and PERTUSSIS VACCINE; (DTP); or with tetanus toxoid alone (DT for pediatric use and Td, which contains 5- to 10-fold less diphtheria toxoid, for other use). Diphtheria toxoid is used for the prevention of diphtheria; DIPHTHERIA ANTITOXIN is for treatment.

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