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Polio clinical trials

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NCT ID: NCT06460545 Not yet recruiting - Hepatitis A Clinical Trials

Phase IV Study of Concomitant Administration of the sIPV and HepA

Start date: June 15, 2024
Phase: Phase 4
Study type: Interventional

This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I in children aged 18 months. The primary immunogenicity endpoints in all groups are the seroconversion rates of type I, II, and III anti-poliovirus neutralizing antibodies and the seroconversion rate of anti-hepatitis A virus antibodies 30 days after the final administration. The secondary immunogenicity endpoints are (1) the GMT/GMC of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration; (2) the seropositive rates of the anti-hepatitis A virus antibodies 30 days after the final administration; (3) the GMFI of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.

NCT ID: NCT06218368 Recruiting - Measles Clinical Trials

A Tool Kit to Improve Vaccine Confidence in the Philippines

Start date: January 31, 2024
Phase: N/A
Study type: Interventional

This cluster randomized controlled trial (RCT) aims to evaluate the feasibility and efficacy of an educational toolkit in enhancing measles, mumps, rubella (MMR) and polio vaccine confidence in the Philippines. The toolkit contains four aspects: an introduction to MMR and polio vaccines, vaccine safety and efficacy, vaccination guidelines (including schedules and locations), and debunking myths and misconceptions. Presented as a 10-minute video and followed by reminder messages from health educators, the toolkit was developed in collaboration with International Care Ministries (ICM) health educators and translated into local dialects. Our toolkit will be embedded in a RCT called the Soap Opera Trial, which is designed and run by the ICM leveraging their community-based Transform Program. The standard Transform Program consists of 15 weeks of education sessions delivered by local health educators through traditional lectures in each community. The trial aims to evaluate the impact of a variation to their standard Transform Program, which uses aspirational videos to deliver education about food security, livelihood, and health. The soap opera to be shown in the video includes drama and plot twists similar to a typical television show but highlights lessons about income creation, health care, and resilience, which are key behaviors and outcomes that can help the poor lift themselves out of poverty. The ICM will conduct this RCT to assess the impact of these soap opera videos on outcomes such as aspirations about the future. A total of 180 communities participating in the Transform program will be randomly assigned to one of the two arms. In the intervention arm, the participants will receive our vaccine toolkit intervention (including educational video and reminding messages about MMR and polio vaccines) and 15 soap opera videos alongside standard Transform Program, while participants in the control arm will receive the standard Transform Program, in which the education sessions are delivered through lectures. The effectiveness of the toolkit will be evaluated by 1) the rate of MMR and polio vaccination among children of the Transform Program participants and 2) knowledge and attitudes towards these vaccines among the participants. Additionally, the relevance, applicability, and feasibility of the toolkit will be assessed using qualitative research methods, and cost-effectiveness of the intervention will be assessed.

NCT ID: NCT06162104 Completed - Fatigue Clinical Trials

Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome

Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to investigate the differences in the severity of fatigue, impact on quality of life, and mood between individuals with post-polio syndrome and healthy volunteer groups. Additionally, the interrelationships of these parameters within the post-polio syndrome patient group will be examined. The goal is to raise awareness during the follow-up process for individuals with post-polio syndrome by questioning fatigue and mood symptoms, and to facilitate the implementation of necessary precautions.

NCT ID: NCT06114810 Not yet recruiting - Polio Clinical Trials

Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV

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

The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV: 1. Addition of IPV after one or several doses of nOPV2 and bOPV to close remaining immunity gaps; 2. Separation of bOPV and nOPV2 with an interval of 4 weeks. Participants at 6 weeks of age will be enrolled and randomized to one of four arms receiving the different polio vaccines; nOPV2, bOPV and IPV, in different combination schedule. The target enrolment is 220 infants per arm for a total of 880. Blood will be collected from all participants to measure Poliovirus antibody titers to types 1, 2 and 3.

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: NCT05850364 Recruiting - Poliomyelitis Clinical Trials

A Multi-center, Open-labelled, Randomized, Controlled, Extended Phase Ⅲ Clinical Trial of sIPV Vaccine

Start date: May 22, 2023
Phase: Phase 3
Study type: Interventional

This 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.

NCT ID: NCT05721274 Completed - Polio Clinical Trials

Community Engagement and Conditional Incentives to Accelerate Polio

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

Immunization 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

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: NCT05083039 Completed - Clinical trials for Coronavirus Infections

Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respiratory Infections, Including COVID-19

Start date: May 14, 2020
Phase:
Study type: Observational

Observational program, double-blind, placebo-controlled to study the preventive efficacy of the BiVac polio (Oral polio vaccine, divalent, live attenuated of types 1 and 3 vaccine against the incidence of acute respiratory infections, including COVID-19

NCT ID: NCT04576910 Completed - Vaccine Reaction Clinical Trials

Immunogenicity and Safety of the Booster Dose of Polio Vaccine With Different Primary Sequential Schedules in China

Start date: November 5, 2020
Phase: Phase 4
Study type: Interventional

This study is to evaluate the immunogenicity and safety of Sabin IPV or bOPV, given as a booster vaccination in children aged 4 years who were previously immunised with different sequential immunization history by Sabin IPV and bOPV, and to observe the antibody persistence three years after different primary sequential immunization with Sabin IPV or bOPV at age 2, 3 and 4 months.