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Pertussis clinical trials

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NCT ID: NCT01233401 Completed - Pertussis Clinical Trials

Tdap Vaccination for Infant Caregivers

Start date: June 2010
Phase: N/A
Study type: Observational

This study evaluates whether offering Tetanus, diphteria and acellular pertussis (Tdap) vaccine to caregivers of newborn infants during pediatric well child visits increase the caregivers' vaccination rates.

NCT ID: NCT01214889 Completed - Tetanus Clinical Trials

Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.

Start date: September 2010
Phase: Phase 3
Study type: Interventional

This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea. Primary Objective: To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the three-dose primary vaccination.

NCT ID: NCT01188512 Completed - Pertussis Clinical Trials

First Adult Safety Trial on Nasal Live Attenuated B. Pertussis Vaccine

Start date: August 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and immunogenicity of a new live attenuated vaccine against whooping-cough. It is a phase1, single centre, dose-escalating, placebo-controlled study on a genetically modified B. pertussis strain given as a single intranasal dose to healthy adult male volunteers. Effective vaccines are needed to protect young infants (from 0 to 6 months, today the most vulnerable age group), preferably after a single administration very early in life. The successful outcome of this project would constitute an important milestone towards nasal vaccination of infants, possibly at birth with a novel, single-dose pertussis vaccine. Our ultimate aim is to protect infants in the most vulnerable age group, before the regular vaccination schedule using already available vaccines is applied. The ultimate aim is thus not to replace current vaccination schedules with available vaccines, but to add a first nasal vaccination to protect very early in life.

NCT ID: NCT01137435 Completed - Tetanus Clinical Trials

Post Marketing Surveillance for ADACEL™ in South Korea

Start date: June 2010
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01129362 Completed - Pertussis Clinical Trials

Rates of Pertussis Disease Among Persons Receiving Pentacel® or Other Pertussis Vaccines

Start date: February 8, 2010
Phase:
Study type: Observational

The purpose of this cohort study is to determine vaccine-specific rates of pertussis disease during the period of the study, among Wisconsin residents younger than 60 months of age (the Surveillance Population), and to descriptively compare the proportion of such persons vaccinated with Pentacel® vaccine who acquire pertussis disease to the proportion of such persons vaccinated with any other Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccine who acquire pertussis disease. Primary Objective: To determine the rates and relative risk of pertussis disease among Surveillance Population members who have received Pentacel vaccine or another pertussis vaccine.

NCT ID: NCT01062477 Completed - Tetanus Clinical Trials

A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants

Start date: January 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China Primary Objectives: - To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination. - To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination. Secondary Objectives: - To describe the safety after administration of the study vaccines. - To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.

NCT ID: NCT01040052 Completed - Tetanus Clinical Trials

A Study to Assess the Safety of Adacel® Vaccine

Start date: December 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to describe the safety of Adacel® vaccination in adults subjects in Vietnam. This study is conducted in accordance with Vietnamese regulation in support to Adacel® registration. Primary objective: To monitor the adverse effects of the vaccine ADACEL® from day 0 to day 30 after immunization.

NCT ID: NCT01031303 Completed - Tetanus Clinical Trials

Immunogenicity and Safety of TETRAXIM™ Given as a Booster Dose at 4 to 6 Years of Age

Start date: December 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and 6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi pasteur DTacP-IPV// PRP~T vaccine (PENTAXIM™) as a three-dose primary and booster vaccinations. Primary Objective : - To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (Pertussis toxoid [PT], Filamentous Haemagglutinin [FHA]) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age. Secondary Objectives : - To describe the antibody persistence in terms of anti-pertussis antibody levels (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria, Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose (at Visit 1) in all subjects at 4-6 years of age. - To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age. - To describe the safety after the booster dose of the study vaccine.

NCT ID: NCT00855855 Completed - Tetanus Clinical Trials

Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

Start date: February 2009
Phase:
Study type: Observational

To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.

NCT ID: NCT00831753 Completed - Hepatitis B Clinical Trials

Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants

Start date: May 2008
Phase: Phase 3
Study type: Interventional

The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa) Primary Objective: To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months) Secondary Objectives: - To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP~T and Infanrix®Hexa) one month after the third dose of the primary series. - To assess the overall safety in each group one month after each dose of the primary series and through the entire study.