Active clinical trials for "Poliomyelitis"

In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups: one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age

In this study, infants will be randomly allocated into three groups: one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation) the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation) the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

The purpose of this study is to evaluate the safety of administering a combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age. Additionally, researchers will assess the body's antibody response (proteins produced by the body's immune system that help fight infections) following each vaccine dose. The study will enroll 5 healthy newborns, ages 0-5 days. Participants will be involved in study related procedures for up to 288 days, including blood sample collection and 5 study visits.

The purpose of this study is to assess the safety (primary objective) and immunogenicity (secondary objective) and fecal shedding of vaccine viruses (secondary objective) of two novel oral polio vaccines, nOPV1 and nOPV3, as compared to Sabin monovalent vaccine controls, in 150-230 healthy adults.

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 For this reason tOPV vaccine was withdrawn globally in April 2016 and switched to bOPV.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

In 2015, Strategic Advisory Group of Experts in Immunization (SAGE) recommended the global switch from trivalent to bivalent oral poliovirus vaccine (OPV) that does not contain type 2 poliovirus and introduction of a single dose of inactivated poliovirus vaccine (IPV) to maintain population immunity to type 2 polio to reduce the risk of vaccine derived polio. Following SAGE recommendations, Nepal introduced one dose of IPV in routine immunization in 2015 followed by withdrawal trivalent OPV in April 2016. However, Nepal, like many other countries had to stop vaccination by the end of 2016 because of a global shortage of IPV. Single dose of IPV induces detectable antibodies in 34% to 80% of infants, compared to >90% after three doses and most of seronegative children (84-98%) are "immunologically primed" by the first dose. Primed individuals produce protective antibody levels in serum within one week of exposure to a new dose of IPV or OPV. However, it is unknown whether seroconversion or priming responses persist, and for how long they persist after the single dose of IPV. IPV immunogenicity for vaccine delivered low-resource countries may also be inferior to that observed in clinical trials because of program factors that decrease vaccine efficacy. This cross sectional study aims to determine whether the immune response provided by a single dose of IPV delivered through routine immunization services persists for more than a year. The study will be implemented in three study sites in Kathmandu, Nepal during November 2018- July 2019. Information generated from this study is expected to allow better estimation of children partially protected (primed) or fully protected against type 2 poliovirus depending on coverage and time since last IPV vaccination. These estimates will help inform the Global Polio Eradication Initiative (GPEI) on vaccine choices for responding to type 2 vaccine derived poliovirus (VDPV) outbreaks and will help guide decisions on polio immunization schedules for Nepal and for other countries in future.

The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.

The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '1+2' sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants

This is an open-label phase IV, randomized controlled trial of mOPV2 alone and mOPV2 along with IPV. This trial will assess the impact on type 2 immunogenicity by reducing the interval between mOPV2 doses. The trial will also evaluate any difference in immunogenicity when the first dose of mOPV2, in a two dose schedule with a four week interval, is administered simultaneously with IPV.

This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.