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Diphtheria clinical trials

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NCT ID: NCT02040636 Completed - Hepatitis B Clinical Trials

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

Start date: January 1999
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT01993173 Completed - Tetanus Clinical Trials

Sanofi Pasteur's Tdap Combined Vaccine as a Booster Versus Local DT Vaccine in Children or Versus Local Td Vaccine in Adolescents and Adults in China.

Start date: November 2013
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT01988857 Completed - Tetanus Clinical Trials

Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children

Start date: February 22, 2014
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01983540 Completed - Hepatitis B Clinical Trials

Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination

Start date: October 2013
Phase: Phase 3
Study type: Interventional

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).

NCT ID: NCT01948193 Completed - Hepatitis B Clinical Trials

Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth

Start date: February 2014
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01933776 Completed - Tetanus Clinical Trials

Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China

Start date: August 2013
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT01929291 Completed - Clinical trials for Diphtheria-Tetanus-acellular Pertussis Vaccines

Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea

Start date: September 23, 2013
Phase:
Study type: Observational

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.

NCT ID: NCT01926015 Completed - Rotavirus Disease Clinical Trials

Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)

Start date: September 19, 2013
Phase: Phase 4
Study type: Interventional

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™.

NCT ID: NCT01917357 Completed - Hepatitis B Clinical Trials

A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject

Start date: September 2013
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01896596 Completed - Hepatitis b Clinical Trials

Hepatitis B Vaccination in Infants

Infanrix
Start date: July 2013
Phase: Phase 4
Study type: Interventional

In the UK, infants currently receive a 5-in-1 vaccine (Pediacel) at 2, 3 and 4 months of age, which protects against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae type b (Hib). Infants also routinely receive a meningococcal group C vaccine (MenC) at 3 and 4 months and a 13-valent pneumococcal vaccine (Prevenar13) at 2 and 4 months of age. This study aims to offer infants a 6-in-1 vaccine (Infanrix-Hexa)that also helps protect against hepatitis B alongside the other routine vaccinations in the UK infant immunisation schedule and assess their immune responses to the different vaccines. Hepatitis B virus infects the liver and usually affects adults, but children can be infected through close contact with carriers of the virus. Children with hepatitis B infection may not have symptoms for many years but may go on to develop liver failure, cirrhosis and cancer. Many other countries already use Infanrix-Hexa and this study is being undertaken to help decide whether the UK can do the same. Babies taking part in this study will receive Infanrix-Hexa instead of Pediacel. All other vaccines given will be the same as in the routine schedule but will include one MenC vaccine instead of 2 doses because the UK infant immunisation schedule is soon going to change so that all babies will receive only one MenC vaccine at 3 months of age. There are currently several licensed MenC vaccines that can be given to babies. In order to check whether there are differences in protection, babies taking part will randomly receive one of 3 MenC-containing vaccines: NeisVacC, Menjugate or Menitorix. Studies have already shown that one dose of Neis-Vac or Menjugate given to babies at 3 months provides similar protection against MenC infection as two doses given at 3 and 4 months. Menitorix protects against both Hib and MenC, so babies in the group receiving MenitorixTM will have an extra dose of Hib which is also included in Infanrix-Hexa but might have a lower antibody response to MenC compared to the other two MenC vaccines, although all infants should be well-protected after their 12-month booster vaccinations, which also contain Menitorix.