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Pertussis clinical trials

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NCT ID: NCT02257645 Not yet recruiting - Hepatitis B Clinical Trials

Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks

Start date: March 2015
Phase: N/A
Study type: Observational

A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B in infants.

NCT ID: NCT02209623 Completed - Pertussis Clinical Trials

TDAP Safety in Pregnant Women

Tdap
Start date: May 2014
Phase: N/A
Study type: Observational

The purpose of this observational study is to evaluate the safety of Tetanus Toxoid Reduced Diphtheria, Toxoid, and Acelluar Pertussis Vaccine (Tdap) in pregnant women at ≥ 20 weeks 0 days gestation receiving Tdap as part of standard practice. Prior Tdap/Td/TT history will be verified by medical record review when possible. There will be an emphasis on enrolling women who have received Tdap before the current pregnancy, to the greatest extent possible. Non-pregnant women who are receiving their initial Tdap will also be recruited. Injection-site (local) and systemic reaction data will be assessed on the vaccination day and during the 7 days following vaccination using either identical web-based or paper diaries, depending on the preference of the study participant. Pregnant women will be followed until delivery with comprehensive obstetric and neonatal outcomes obtained from review of the electronic medical record.

NCT ID: NCT02118961 Completed - Tetanus Clinical Trials

Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents

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

This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a booster dose in adolescents. The purposes of this study are as follows: - To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies - To confirm that booster responses for anti-pertussis toxoid (anti-PT) and anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants received BK1301

NCT ID: NCT02096276 Completed - Pertussis Clinical Trials

Boostrix® Pregnancy Registry

Start date: March 31, 2014
Phase:
Study type: Observational

The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to Boostrix during their pregnancies in the US. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with Boostrix during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively

NCT ID: NCT02094833 Completed - Hepatitis B Clinical Trials

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

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

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

NCT ID: NCT02089347 Completed - Tetanus Clinical Trials

Study of SP306 Given Intramuscularly Compared to DT BIK® Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old

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

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.

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: NCT02014519 Completed - Pertussis Clinical Trials

A Study to Determine the Seroprevalence of Bordetella Pertussis in Adults in Hungary

Start date: April 24, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to perform an epidemiological survey of the adult population in Hungary to calculate the seroprevalence of pertussis.

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: NCT01984125 Completed - Influenza Clinical Trials

Testing the Use of Prompts to Increase Adolescent Immunization Rates

AIMHi
Start date: April 2011
Phase: N/A
Study type: Interventional

Although most US adolescents visit their primary care doctor, their immunization rates are low. Primary care practices from two networks, one in upstate New York as well as a national network of pediatric clinics were surveyed to ask what they thought was the best strategy to increase immunization rates. Point-of-care prompts (either by an electronic health record message or by a nurse) when an adolescent patient comes in for any type of visit and is due for a vaccine was chosen. This study will determine if these prompts will increase immunization rates after a 12-month intervention period.