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Poliomyelitis clinical trials

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NCT ID: NCT06101173 Active, not recruiting - Poliomyelitis Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults

Start date: January 15, 2024
Phase: Phase 1
Study type: Interventional

This is a randomized, observer-blind, positive-controlled study. There will be 3 treatment groups, in each treatment group, participants will be randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio that are defined as Dose A, Dose M, and Dose H, respectively) or control vaccine in a ratio of 3:1 in each group. Distribution of participant's gender should be balanced in each group.

NCT ID: NCT06058429 Active, not recruiting - Polio Clinical Trials

Immunogenicity of After Primary Immunization and Booster Immunization of sIPV

Start date: August 16, 2023
Phase:
Study type: Observational

This study was conducted on the basis of "Safety Observation of Sabin Strain Inactivated Polio Vaccine (Vero Cell) on primary Immunization, Booster Immunization and Simultaneous Vaccination with Other Vaccines in Infants and Young Children(ID: PRO-sIPV-MA4001-JX). Blood samples were collected in about 200 qualified subjects 1-9 months after their last vaccination of sIPV. And immunogenicity of sIPV and other vaccines simultaneously administrated will be tested, the antibodies against enterovirus (including EV71、CA16、CA6 and CA10) will also be tested.

NCT ID: NCT05684081 Active, not recruiting - Polio Clinical Trials

Effect of Digital Payment to Campaign Health Workers on Vaccination Coverage

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Introduction: Good quality OPV campaigns can interrupt and possibly prevent transmission of the polio virus. Health care worker performance and motivation are prerequisites for the success of such campaigns. Complete, transparent and timely payments are, in turn, prerequisites for the sustenance of health care worker motivation and thereby efforts. To date, most such health care workers have been paid in cash, with chronic payment issues that have negatively affected campaign quality and vaccination coverage. Cash-based payments are often plagued with multiple delays in funds disbursements, cash leakages, and a lack of accountability and financial transparency. These difficulties have prompted a transition to digitized payments that are perceived to be faster, more convenient, traceable, reliable, easier and more reasonable to set up. The roll-out phase of these digital payment interventions has not been quantitatively evaluated and the effect of digital payments on the motivation, satisfaction and performance of health workers is not known. Therefore, this study will compare digitized payment of polio vaccination campaign health care workers with cash-based payment with regards to health care worker motivation, satisfaction and performance. Findings from this study may inform the operationalization of digital financial systems, and the transition towards cross-campaign digital payments. Primary Objectives: 1. To compare the motivation, satisfaction and performance of vaccination health care workers in areas where they are paid using mobile money versus in cash, 2. To explore how gender norms and relations influence health workers' response to payment systems (mobile money versus cash payments) and how these affect the health workers' performance and motivation in polio vaccination campaigns and Secondary objectives: 1. To compare vaccination campaign quality in areas where health care workers are paid using mobile money versus in cash 2. To compare vaccination coverage in areas where campaign health care workers are paid using mobile money versus in cash. 3. To estimate the incremental cost of the intervention. Methods: This will be a mixed methods study including a cluster-randomized controlled implementation trial and a qualitative study. A total of 60 districts be randomized to implement either a digital payment system for polio campaign vaccinators during the polio campaign or the traditional cash-based payment system.

NCT ID: NCT05677256 Active, not recruiting - Poliomyelitis Clinical Trials

A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2

Start date: November 9, 2023
Phase: Phase 4
Study type: Interventional

The study will compare the poliovirus type-2 pharyngeal mucosal excretion in the first week, and at 2 and 4 weeks following the administration of a challenge novel OPV2 (nOPV2) dose at 18 weeks of age in 2 parallel groups of infants

NCT ID: NCT05327426 Active, not recruiting - Poliomyelitis Clinical Trials

Intradermal Fractional Dose IPV (fIPV) in Combination With dmLT

Start date: April 1, 2022
Phase: Phase 1
Study type: Interventional

This is a single site, phase 1 study of dmLT as a mucosal adjuvant to control fecal viral shedding when used in combination with intradermally administered fractional dose trivalent IPV (fIPV). It will be a 2-arm, randomized, double-blind controlled trial of intradermal fIPV versus fIPV+dmLT in healthy adults with a monovalent oral polio vaccine (OPV) challenge administered as a test of mucosal immunity. A maximum of 30 healthy subjects will be recruited, all of whom will have received IPV only as part of their primary childhood immunization series (cohort 1); they will be randomized 2:1 to receive fIPV-dmLT or fIPV alone. A maximum of 27 participants will be recruited from an earlier pilot study population exposed to fIPV+/-dmLT and will provide follow-up samples for immunologic studies only (cohort 2).

NCT ID: NCT03561623 Active, not recruiting - Post-polio Syndrome Clinical Trials

Spinal Cord Gray Matter Imaging in Post Polio Syndrome

Start date: May 22, 2017
Phase:
Study type: Observational

This is a longitudinal, observational study with the aims of comparing spinal cord gray matter areas in patients with Post-Polio Syndrome to age and sex matched healthy control subjects and to correlate atrophy with metrics of clinical disability.

NCT ID: NCT03286803 Active, not recruiting - Poliomyelitis Clinical Trials

Comparison of Immunity Following IPV Versus fIPV: a Community Based Randomized Controlled Trial in Pakistan

CODI
Start date: August 1, 2017
Phase: Phase 4
Study type: Interventional

This study will be conducted in four low-income areas of Bin Qasim Town Karachi. This will be a community based randomized control trial of 21 months duration. The trial will include four arms; arm A and B will enroll children age 14-18 weeks and randomize them to either full dose IPV (0.5ml) or fractional IPV (0.1ml). Arms C and D will enroll children at 9 months of age and randomize them to either fractional or full dose IPV. Children aged 14 weeks for arms A and B and 9 months for arms C and D living in the selected communities of Bin qasim Town Karachi who have not received IPV vaccine during routine immunization for arms A and B and who have documentary evidence of receiving IPV vaccine at 14 weeks of age for arms C and D will be eligible for enrollment. The investigators will exclude children who are found acutely ill or those requiring emergent medical care/hospitalization at the time of enrollment. The investigators will use the Demographic Surveillance System (DSS) in the four study areas to identify the households with eligible children. The children of the parents who agree to participate in the study will be screened for eligibility by the trained research associates. After randomization into four different arms, the study trained research vaccinators will administer the IPV or fIPV as per randomization. Children will be observed in the center for 30 minutes after vaccination before leaving for home. Parents/guardians of all the participants will also be requested to immediately report any adverse effect occurring later. This study will be conducted in compliance with this protocol, GCP guidelines and all applicable international and local regulatory requirements. The study has approval by the Ethical Review Committee of the Aga Khan University (AKU), the National Bioethics Committee of Pakistan, and ethical approval at WHO/Headquarters in Geneva. All study procedures will be conducted in AKU's field research sites from where subjects will be recruited. The Clinical Trials Unit (CTU) of AKU will be engaged in providing support for specific study procedures conducted at CTU such as randomization, management of vaccines (storage, dispensing and incineration), and other responsibilities agreed in writing. Adverse events following vaccine administration will be monitored and all serius adverse events will be reported within 24 hours to WHO, DSMB and AKU IRB. All the vaccines used are licensed in Pakistan and in routine use.

NCT ID: NCT02089880 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis

Start date: February 2014
Phase: N/A
Study type: Interventional

The study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.

NCT ID: NCT01908114 Active, not recruiting - Polio Clinical Trials

To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based Intervention Package for Polio Eradication in Pakistan

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

The objective of the projects is to Develop and implement a Package of interventions that will comprise of an augmented communication and counseling strategy coupled with private sector involvement and a combined Oral Polio Vaccine and Inject able Polio Vaccine approach during the Polio campaigns followed by the evaluation of this project for acceptability, feasibility and effectiveness of the intervention Package.