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Pertussis clinical trials

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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: NCT04694963 Not yet recruiting - Pertussis Clinical Trials

A Multi-center Study to Determine the Prevalence and Influence of Pertussis on Subacute Cough in Shenzhen

Start date: January 1, 2021
Phase:
Study type: Observational

A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of COPD pertussis and the impact of pertussis on subaute cough.

NCT ID: NCT04694430 Not yet recruiting - COPD Exacerbation Clinical Trials

A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen

Start date: January 1, 2021
Phase:
Study type: Observational

A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of chronic obstructive pulmonary disease (COPD) pertussis and the impact of pertussis on COPD exacerbation.

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: NCT04589312 Completed - Pertussis Clinical Trials

Maternal Pertussis Wholecell Responses

WoMANPOWER
Start date: October 21, 2020
Phase: Phase 2
Study type: Interventional

Pertussis is resurging worldwide. In Africa alone it is estimated that there are 2.1 million cases and 542,000 deaths from pertussis in infants under 1 year with the highest rates of morbidity and mortality in infants <3 months old, before possible prevention via the infant immunization programme1. To protect these most vulnerable infants, the World Health Organisation (WHO) recommends Tdap vaccination as safe in pregnancy and recommends the use of wP vaccines within the EPI. Maternal antibody following aP vaccination can interfere with infant anti-pertussis antibody responses post infant EPI vaccination, which is of concern in high burden settings such as Uganda. There are therefore multiple factors in this population which may influence the effect of pertussis immunization in pregnancy, and which have not been studied, most notably HIV infection and interference with wP vaccines in infants. The immunogenicity of Tdap in HIV-infected pregnant women has not yet been examined. In addition, to date, the effect of maternal vaccination, placental transfer and infant antibody responses in HEU infants have not been studied at all. There are no studies examining the immune response to wP vaccine administered to infants (EPI recommendation) whose mothers received aP in pregnancy.

NCT ID: NCT04543669 Completed - Pertussis Clinical Trials

Adacel® Booster Vaccination for CMI Assay Development

Start date: July 12, 2017
Phase: Phase 4
Study type: Interventional

Recruitment of individuals primed during childhood with TdaP (tetanus, diphtheria , acellular pertussis) vaccine, and administration of an Adacel booster with blood sample collection at various time points before and after vaccination. Collection of blood sample volumes will be large enough to allow assessment and comparison of multiple assays that evaluate cell-mediated immune (CMI) responses and other biomarkers following the administration of pertussis vaccinations. The ultimate objective would be to utilize these validated assays for evaluation of pertussis clinical trial results or development of new pertussis vaccine formulations.

NCT ID: NCT04535505 Withdrawn - Pertussis Clinical Trials

Pathogenic Bordetella Rapid Detection

Start date: July 2022
Phase:
Study type: Observational

A CPA platform based on the CRISPR technology is going to established to achieve the goal of detecting pathogenic bordetella and drug resistance genes in one step. The accuracy of this platform will be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identification would be set as a gold standard method.

NCT ID: NCT04529720 Completed - Pertussis Clinical Trials

5-year Follow-up After a Single Dose Acellular Pertussis Vaccination

Start date: August 24, 2020
Phase:
Study type: Observational

In July 2015-November 2016, a phase II/III randomized, observer-blind,controlled study of two acellular Pertussis vaccines (aP standalone and TdaP combined vaccines) manufactured by BioNet-Asia Co., Ltd. (Bionet) and chemically-detoxified Adacel Tdap vaccine was conducted in Bangkok, Thailand in healthy participants aged 12-17 years (Protocol No. TDA202; http://clinicaltrials.in.th;Study ID:TCTR20150703002). A total of 450 participants were enrolled into the study at 2 study sites (Site No.1:Faculty of Medicine Siriraj Hospital; Site No.2:Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University) with equal number of 225 participants enrolled at each study site. During the study, the participants had been randomized in a 1:1:1 ratio to received intramuscularly a booster dose (0.5 mL) of the study vaccines. This is further follow-up from TDA202 clinical trial, which was completed on 29 November 2016. Target population for this study is the group of participants who had received one dose of one of the three study vaccines in the TDA202 trial at site VTC and who had completed the study follow-up at 1-year after vaccination (223 subjects). In this current study, the long-term persistence of pertussis antibodies induced by a booster dose of recombinant acellular Pertussis based vaccines (Pertagen and Boostagen) manufactured by Bionet will be evaluated and compared to the conventional chemically-inactivated Tdap vaccine (Adacel) at 5 years after previously immunized in the TDA202 study.

NCT ID: NCT04177485 Completed - Hepatitis B Clinical Trials

Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

Faced with high rates of immunization drop-out, Uganda's immunization program requires innovative approaches to address this weakness. Building upon Uganda's growing mHealth infrastructure to pilot a scalable short message service (SMS) system to remind caregivers of their children's upcoming vaccination visits, it was hypothesized that the SMS intervention will increase immunization coverage in a cost-effective and affordable manner that would make it scalable. The study design was an investigator-blinded, multi-center, parallel groups randomized controlled trial with randomization occurring at the caregiver level in select health facilities of Arua District in Uganda. Enrollment took place at the time of Pentavalent 1 vaccination, and both arms included standard of care provided by the health worker. However, in the intervention arm, caregivers also received SMS text messages reminding them to return for their children's second and third doses of Pentavalent vaccine (four and eight weeks after the first dose of Pentavalent vaccine) and measles-containing vaccine (9 months of age). The primary outcome of interest is vaccination coverage at 12 months of age among children enrolled in the study and will be measured by comparing Penta3 and MCV coverage between arms. The study will also examine the SMS impact on timeliness of vaccine receipt, as it is hypothesized that those children receiving the SMS intervention will be more likely to have timely vaccination than those in the control group. The study will also assess caregiver acceptability and cost-effectiveness of the SMS intervention. In addition to assessing its impact on strengthening the immunization program, this intervention has implications for strengthening other programs of the health system through similar health messaging directed toward caregivers.

NCT ID: NCT04113655 Completed - Pertussis Clinical Trials

2-year Follow-up After a Single Dose Acellular Pertussis Vaccination

Start date: June 20, 2017
Phase:
Study type: Observational

In July 2015-November 2016, a phase II/III randomized, observer-blind,controlled study of two acellular Pertussis vaccines (aP standalone and TdaP combined vaccined) manufactured by BioNet-Asia Co., Ltd. (Bionet) and chemically-detoxified Adacel Tdap vaccine was conducted in Bangkok, Thailand in healthy subjects aged 12-17 years (Protocol No. TDA202; http://clinicaltrials.in.th; Study ID:TCTR20150703002). A total of 450 subjects were enrolled into the study at 2 study sites (Site No.1:Faculty of Medicine Siriraj Hospital; Site No.2:Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University) with equal number of 225 subjects enrolled at each study site. During the study, the subjects had been randomized in a 1:1:1 ratio to received intramuscularly a booster dose (0.5 mL) of the study vaccines. In this current study, persistence of pertussis antibodies induced by a booster dose of recombinant acellular Pertussis based vaccines (Pertagen and Boostagen) manufactured by Bionet will be evaluated and compared to the conventional chemically-detoxified Tdap vaccine (Adacel) at 2 years after previously immunized in the TDA202 study.