View clinical trials related to Poliomyelitis.
Filter by:This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial at age 2, 4, and 6 months. The IPV-Al SSI vaccine will be given at the age of 15-18 months.
With the progress of the eradication of polio, bivalent oral attenuated live poliomyelitis vaccine against type 1 and 3 (bOPV) and inactivated poliomyelitis vaccine made by Sabin strain (sIPV) are required to use in the "Strategy of Polio Eradication & Endgame Strategic Plan 2013-2018" worldwide. To evaluate the safety and immunogenicity by different sequential schedules of bOPV/tOPV with IPV(sIPV/cIPV), a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Infants of two-month-old in Guangxi Province, China.
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.
This will be a single center, age de-escalation, partly-blinded, randomized study. The trial will be performed with the participation of 100 healthy children age 1-5 years who have been vaccinated with inactivated polio vaccine (IPV) and/or oral polio vaccine (OPV) in their first year of life and of 648 healthy 6 week-old infants, who will be pre-vaccinated with bOPV-IPV before being randomized to study groups. The allocation of 18-22 week-old infants to groups will be performed in a randomized manner. Following completion and Data Safety Monitoring Board (DSMB) review of follow-up for general safety data (Serioius Adverse Events -SAEs-, Important Medical Events -IMEs- and severe adverse events -AEs), a DSMB recommendation to proceed will result in randomization of the final cohort of infants. Allocation of 1 to 5 year-old children to groups will be performed in a randomized manner. The DSMB will establish and continuously assess stopping rules for safety.
This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy. The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.
The purpose of this phase III study is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in 2-month-old infants.
This first-in-human (FIH) phase 1 study is designed to evaluate in contained conditions the safety, immunogenicity, shedding, and genetic stability of two novel oral polio vaccine type 2 (nOPV2) vaccine candidates in IPV-primed adults before testing in a larger adult and adolescent (> 15 y of age) population, and then in young children and infants.
Many patients with polio sequelae have persistent and progressive worsening more than 15 years after the initial damage, with loss of muscle strength, asthenia and musculoskeletal pain. In these patients, there is a denervation process associated with insufficient reinnervation. The frequency of this syndrome post-polio (SPP) is of the order of 20 to 60% according to the studies. In the literature, several studies have advanced the hypothesis of immune dysregulation to this late degradation, with greater expression of pro-inflammatory cytokines, and abnormal phenotypic expression of T cells in the bloodstream. In this context, the use of immunomodulatory immunoglobulin IV treatment was studied several times, with no significant result on pain, fatigue and muscle strength scores. In the absence of significant efficacy of immunoglobulin treatment, the objective of this study is therefore to define the immunological profile of patients with post-polio syndrome, compared with control subjects, in order to support the pathophysiology of this syndrome. to study the possible presence of an inflammatory syndrome associated with this syndrome. On the other hand, depending on the results found, referral to targeted therapies could be considered.
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.
This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta co-administered with Imovax Polio in healthy adults.