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Pertussis clinical trials

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NCT ID: NCT06286007 Recruiting - Asthma Clinical Trials

Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control

PRIPASCO
Start date: December 21, 2023
Phase:
Study type: Observational [Patient Registry]

The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI). A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study. Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up

NCT ID: NCT06184542 Recruiting - Tetanus Clinical Trials

Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine

Start date: December 23, 2023
Phase: Phase 1
Study type: Interventional

This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.

NCT ID: NCT06056050 Recruiting - Tetanus Clinical Trials

A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)

Start date: December 6, 2023
Phase: Phase 1
Study type: Interventional

Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal disease caused by Clostridium tetani infection. Currently, there is no clinical trial registration of Diphtheria, tetanus, and pertussis (DPT) vaccine applicable to ≥6 years of age in China, therefore, the five-component acellular DPT combination vaccine developed by our research has a promising future.

NCT ID: NCT05193734 Recruiting - Pertussis Clinical Trials

Safety and Immunogenicity of 2 Doses Versus 1 Dose of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin in Young Adults Previously Primed With Acellular Pertussis Vaccines

Pertagen2x
Start date: February 7, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

A significant increase of pertussis incidence is reported in a growing number of countries. This resurgence is considered as resulting from the limited durability of aP-vaccine-induced immunity and is associated with increased mortality in young infants and morbidity at all age groups. As the pertussis immunity acquired through immunization or infection is short-lived, its maintenance or reactivation requires repeat boosting at regular time points. Thus, novel strategies capable of reactivating pertussis immunity are needed. The efficacy of current acellular pertussis vaccines (which contain chemically-detoxified pertussis toxoid (PT)) rapidly wanes, in part because priming and repeat immunization with acellular vaccines induce antibodies specific for the chemically-detoxified PT but unable to efficiently recognize the native PT expressed by B. pertussis. Clinical studies have shown the superior immunogenicity profile of acellular pertussis vaccines including genetically-detoxified PT (rPT) in adults and adolescents previously primed with aP. In particular, the investigators showed in a past Geneva study in teenagers previously primed with aP that rPT/FHA induced a stronger recall response than the current aP-vaccine at one month post-vaccination. However, the difference was less clear one year after vaccination, suggesting that 2 doses may be needed for more sustained immunity. In the present study, the investigators would like to assess whether giving two doses of rPT/FHA at 6 months interval induces stronger immune responses than a single dose.

NCT ID: NCT05136599 Recruiting - Pertussis Clinical Trials

Establishing a Controlled Human Infection Model of Bordetella Pertussis

Start date: January 28, 2022
Phase: Phase 1
Study type: Interventional

This study aims to establish a Controlled Human Infection Model of Bordetella pertussis by determining a reproducible and safe infectious bacterial dose (challenge inoculum) that achieves colonization and mild symptomatic infection in healthy adults.

NCT ID: NCT04779853 Recruiting - Pertussis Clinical Trials

Seroprevalence of Pertussis Among Healthy Children and Adolescents in Kazakhstan

Start date: January 25, 2021
Phase:
Study type: Observational

Seroprevalence of pertussis among older children and adolescents in Kazakhstan: A cross sectional study. Justification: to describe the distribution of anti-pertussis toxin (PT) antibodies (IgA and IgG) in a population aged 10-18 years old according to sociodemographic characteristics, vaccination history, and risk factors of pertussis infection.

NCT ID: NCT04618640 Recruiting - Tetanus Clinical Trials

To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 Years

Aladdin
Start date: December 26, 2019
Phase: Phase 3
Study type: Interventional

The study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against diphtheria, tetanus, pertussis, and polio.

NCT ID: NCT04023929 Recruiting - Prematurity Clinical Trials

Sources of COmplement in Meningococcal and Pertussis Serum Bactericidal Antibody Assays

COMPAre
Start date: October 28, 2020
Phase:
Study type: Observational

This study is designed to allow cord blood sample collection from the cords of babies born in three gestational age windows: ≥37 gestational weeks, 32-36+6 gestational weeks and less than 32 gestational weeks to investigate whether the result obtained using a standard hSBA assay is comparable to that achieved using complement from a gestation matched population for meningococcal B and pertussis.

NCT ID: NCT03982732 Recruiting - Pregnancy Clinical Trials

Maternal Antibody in Milk After Vaccination

MAMA
Start date: August 7, 2018
Phase:
Study type: Observational

Single-centre observational pilot study exploring pertussis specific antibody concentration in the breastmilk of women vaccinated against pertussis in pregnancy at different gestational ages. This study is made up of two stages: first stage to confirm recruitment methods and optimise the laboratory assay and a second stage to complete recruitment for the pilot study.

NCT ID: NCT02821195 Recruiting - Hepatitis B Clinical Trials

Study of Sanofi Pasteur's DTaP-IPV Hep B-PRP-T Combined Vaccine in Infants Who Previously Received Hepatitis B Vaccine

Start date: April 2015
Phase: Phase 3
Study type: Interventional

Phase III, open, mono-center study in 177 infants who received a dose of Hep B vaccine at birth or within 1 month after birth. Infants will receive Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine (study vaccine) at 2, 3, and 4 months of age. All subjects will provide blood samples for immunogenicity assessment at baseline (pre-vaccination) and at 30 days following the third vaccination. Regarding safety, solicited reactions and unsolicited non-serious adverse events (AEs) will be collected up to 7 days and up to 30 days after each vaccination, respectively. Serious adverse events (SAEs) will be collected throughout the study trial (from Visit 1 to Visit 4)