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Showing 1-20 of 39 trials
NCT06442449
This is an Open-labeled, Randomized, Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of Sabin Strain Inactivated Poliovirus Vaccine (Vero cell) (sIPV) Co-administered with Measles, Mumps, Rubella (MMR) Combined Live Attenuated Vaccine and Inactivated Hepatitis A (Hep-A) Vaccine.
NCT05644184
The 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 (720 subjects), and neonates (1320 subjects).
NCT06947499
The purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of LBVD in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants
NCT06137664
The main objectives of this study are to : * evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines; * evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control. * compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates; * evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.
NCT05431933
Eupolio 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.
NCT06346834
To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV.
NCT06752174
The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1 sequential" immunization program (sIPV-sIPV-bOPV) in 2-month-old healthy infants.
NCT06101173
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.
NCT05386810
This study includes two parts.A clinical trial with a open-label to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml-5 doses)(hereinafter referred to as "msIPV")manufactured by Sinovac Biotech Co., Ltd. in adults, children and infants in partⅠ and a blinded,randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msIPV in 2 months old infants in partⅡ.
NCT06320444
Substantial variability exists in the onset, and rate of degeneration across individuals with Motor Neurone Disease (MND) or Amyotrophic Lateral Sclerosis (ALS). This variability requires biomarkers that accurately classify and reliably track clinical subtypes as the disease progresses. Degeneration occurs in the brain and spinal cord, however, non-invasive diagnosis of spinal cord function remains highly challenging due to its unique alignment in spine. Disruption of complex spinal and cortical circuits that transmit and process neural signals for position sense and movement has not been adequately captured in the neurophysiological profiling of ALS patients. The overarching aim of this study is to reveal and quantify the extent of change in the sensorimotor integration and its potential contribution to network disruption in ALS.
NCT04220515
This study includes both active and passive safety monitoring in large pupulations for the phase IV safety monitoring study of Inactivated Poliomyelitis Vaccine Made From Sabin Strain (sIPV).
NCT02231632
The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell)
NCT03239496
The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule combinations in the Expanded Program on Immunization (EPI) primary series.
NCT02458183
The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.
NCT05457946
The purpose of this study is to evaluate immunogenicity and safety of different doses of candidate hexavalent vaccine in comparison to co-administration of Pentavalent vaccine and Poliomyelitis Vaccine (Inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine(Stage 1) and to demonstrate lot-to-lot consistency of three lots of LBVD (Stage 2)
NCT04693286
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
NCT04614597
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.
NCT04448132
The trial is a phase 4, open-label, multicentre clinical trial with healthy subjects who have been vaccinated with IPV-Al AJV at 2, 4, 6 and 15 18 months of age in previous trials. Levels of antibodies against poliovirus types 1, 2 and 3 after immunisation with IPV Al AJV will be measured in the trial subjects at the age of 4 years. An additional IPV-Al AJV dose (investigational vaccine) will be administered and the booster response to IPV-Al AJV will be investigated one month after administration.
NCT04080687
The patients at our Prosthetics and Orthotics Outpatient Clinic who have had an ankle-foot orthosis for at least one year will fill in the Activities-Specific Balance Confidence Scale (ABC Scale) for wearing the orthosis and for not wearing the orthosis. They will also answer a mini survey about falls in order to determine whether they have fallen within the last 6 months.
NCT03597919
In April 2017, WHO recommended that a two-dose, Inactivated Poliovirus Vaccine, IPV-only schedule at 4 months and 8 months of age can be used after polio eradication, with a schedule seroconversion target of at least 90%. However, there is no such data for China domestic Sabin strain IPVs to support a 2-dose schedule among Chinese infants. This research is to determine the seroconversion rates among two arms: Group 1: two-dose schedule, infants will be received two doses of Sabin IPV, the first dose at 4 month of age, and the second dose at 8-11 month of age. Group 2: three-dose schedule, infants will be received three doses of Sabin IPV at 2, 3 and 4 month of age respectively. This schedule is currently recommended by manufacture's package insert for routine use. The hypothesis is the seroconversion will be above 90% in both groups.