High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners...
Neurologic DisorderParkinson Disease6 moreIndividuals with and without neurologic diagnoses greatly benefit from participation in regular exercise but the majority are physically inactive. This is an issue for both them and their care partners as their health is often linked. This study aims to examine the long-term physical and psychosocial effects of structured, group-based, high intensity functional training (HIFT) exercise for people with neurologic diagnoses and their care partners.
A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine...
PoliomyelitisPolioThis study is designed to study the immunogenicity and safety of sIPV co-administered with other routine infant vaccines. According to the national immunization schedule of Bangladesh and Pakistan, sIPV was administered concomitantly with PCV10, DTP-HeB-Hib and other vaccines at 6, 10 and 14 weeks old. Thus, this study set up the concomitant vaccination schedule according to the real practice in study area. The primary hypothesis of this study is the seroconversion rate of polio vaccination when administered concomitantly with routine vaccines, is non-inferior to that when administered alone; the secondary hypothesis of this study is the seropositivity rate of diphtheria, tetanus, and pertussis when routine vaccines are administered concomitantly with sIPV, is non-inferior to that administered without sIPV.
Study to Evaluate Eupolio(IPV)'s Safety, Long-term Protective Effect and Boosting Effect of One...
PoliomyelitisVaccine ReactionEupolio is inactivated poliovirus vaccine (IPV). Major purpose of this study is to evaluate safety of Eupolio in 2,000 infants. In addition to the safety, long-term protection after completion of the three primary vaccinations and extent of protective level after a single boosting dose of Eupolio will be evaluated. As IPV plus bOPV vaccination schedule (3 doses of bOPV plus 2 doses of IPV in infant-toddle vaccination schedule) has been implemented in some countries, this study will also evaluate Eupolio's safety and protective effect in that schedule.
Community Engagement and Conditional Incentives to Accelerate Polio
PolioImmunization; Infection1 moreImmunization is one of the most cost-effective and successful public health strategy in reducing the health, economic and societal burden of many infectious diseases. Pakistan and Afghanistan remain the only countries where polio is endemic, and Pakistan reports the most cases in the world. Although the rate is lower than in previous years, the situation remains alarming. This study objective is to decrease polio vaccine refusals and zero-dose vaccines by motivating behaviour change
Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
PoliomyelitisThe purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (336 subjects), and neonates (1155 subjects).
Intradermal Fractional Dose IPV (fIPV) in Combination With dmLT
PoliomyelitisThis 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).
Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV When...
PoliomyelitisFollowing a recommendation on October 2017 meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization; low- risk bOPV-using countries may adopt 2 dose fIPV schedule prior to global OPV cessation as it provides better seroconversion than 1 full dose IPV and in the post-cessation era, the 2 fIPV doses will provide sufficient (above 90%) seroconversion. Countries, which delayed the introduction of IPV or had a vaccine stock-out, should provide 1 full dose or 2 fIPV doses to all children who were missed as soon as supply becomes available. The IPV supply situation is expected to improve in 2018; all countries are expected to have access to IPV for their routine immunization programmes from the end of the first quarter of 2018. While immunogenicity after one and two doses of IPV and fIPV has been estimated when administered to younger children ; the immunogenicity of IPV (or fIPV) when administered at 9 months of age or later is not known. We propose to conduct a study to assess the immunogenicity of one and two doses of fIPV and IPV when administered between 9-13 months of age.
Assessing Immunogenicity of Intramuscular Sabin Inactivated Poliovirus Vaccine and Non-inferiority...
PoliomyelitisThis is an open label and off label, phase IV, randomized clinical trial that will compare the immune response among infants that receive either two full doses of Sabin IPV intramuscularly or two fractional (1/5) dose of Sabin IPV intradermally at 14 weeks and 9 months of age from two different manufacturers.
Effect of Digital Payment to Campaign Health Workers on Vaccination Coverage
PolioIntroduction: 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: To compare the motivation, satisfaction and performance of vaccination health care workers in areas where they are paid using mobile money versus in cash, 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: To compare vaccination campaign quality in areas where health care workers are paid using mobile money versus in cash To compare vaccination coverage in areas where campaign health care workers are paid using mobile money versus in cash. 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.
A Study to Evaluate Safety and Immunogenicity of APV006 in Healthy Adults
DiphtheriaTetanus4 moreThis is a single-center, randomized, active-controlled, parallel-design, double-blind, phase I study to evaluate the safety and immunogenicity of a single dose of APV006 in healthy adults.