View clinical trials related to Poliomyelitis.
Filter by:The study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months who have never received vaccination against poliomyelitis.
This Phase III study has been designed to compare the SII Inactivated Salk Polio Vaccine (Adsorbed) with Sii licensed IPV by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific poliovirus neutralizing antibody (PVNA) to poliovirus type 1, type 2 and type 3 by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of SII Inactivated Salk Polio Vaccine (Adsorbed) by demonstrating equivalence in the induction of PVNA across three production lots.
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
Study to determine immunogenicity and safety following administration of 2 doses of novel oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or the standard 4-week interval in infants
This is an open and observational follow-up clinical trial based on the previous Phase III clinical trial of Sabin Inactivated Poliovirus Vaccine manufactured by Sinovac Biotech Co. , the purpose of this study is to evaluate the immunity persistence of sIPV in infants after 4 doses of vaccination.
Though OPV is safe and effective, it can mutate and reacquire neurovirulence in rare circumstances. This can result in vaccine-associated paralytic polio and circulating vaccine-derived polioviruses. Use of tOPV had risk of generating VAPP and seeding new type 2 circulating vaccine-derived polioviruses though wild type 2 virus was eradicated in September 2015. For this reason tOPV vaccine was withdrawn globally in April 2016 and switched to bOPV. cVDPV2 outbreaks have occurred in sixteen countries after cassation of OPV2. Using stockpiled mOPV2 to respond to this situation risks propagating new cVDPVs. IPV induces only limited intestinal mucosal immunity not effective to interrupt fecal-oral route transmission in settings of poor hygiene and sanitation. Therefore, development of novel oral polio vaccine with enhanced genetic stability and lower risk of reversion to neurovirulence compared to current Sabin 2 strains is major priority of global polio eradication Program Current clinical development plan outlines studies through Phase II development with nOPV2 candidate strains being tested in adult toddler and infant populations who received prior dose of OPV or IPV. No study has been conducted in truly naive newborns with no prior receipt of any polio vaccines Hypothesis: Vaccinating healthy newborns with novel type 2 polio virus candidate vaccines is safe and can induce putatively protective immune response Objectives Primary Objective Safety To evaluate the safety and tolerability after one and two doses of nOPV2 vaccine candidates 1 given 4 weeks apart in poliovirus vaccine-naïve newborn Immunogenicity To evaluate the immune response to vaccination after one and two doses of nOPV2 vaccine candidate 1 given 4 weeks apart in poliovirus vaccine-naïve newborns Secondary objectives Immunogenicity To evaluate seroprotection rate geometric mean and median titers to vaccination after one dose of nOPV2 vaccine candidate 1 in poliovirus vaccine-naïve newborns To further evaluate seroprotection rate geometric mean and median titers to vaccination after two doses of nOPV2 candidate 1 in poliovirus vaccine-naïve newborns Viral Shedding To assess trate of fecal viral shedding at fixed time points following one and two doses of nOPV2 vaccine candidate 1 in newborns To assess duration of fecal viral shedding at fixed time points following one and two doses of nOPV2 vaccine candidate 1 in newborns To assess extent of fecal viral at fixed time points following one and two doses of nOPV2 vaccine candidate 1 in newborns Exploratory objective To assess genetic stability through genetic deep sequencing assay and neurovirulence test through transgenic mice NV assays from a subset of participants stools samples
This study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains.
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.
In 2017, China CDC conducted a study titled "A Study of Immunogenicity and Seroconversion With Sabin IPV Schedules in China". At present, all the infants in the monitoring cohort were over 18 months old and at least one year had elapsed since the last dose of sIPV inoculation.Since there is no any data about the protection duration of two-dose Sabin IPV schedules, China CDC propose to follow up the study cohort to evaluate the proportion of seroprotection of antibody and measure neutralizing antibody titers against poliovirus at over 18 months of age infants after a 2-dose or a 3-dose primary schedule of Sabin IPV in Chinese children.
This is an open-label randomized clinical trial that will compare immune responses among infants who receive either novel monovalent oral poliovirus vaccine type 2 (nOPV2) alone, bivalent oral poliovirus vaccine (bOPV) alone, or co-administered nOPV2 and bOPV.