Track topics on Twitter Track topics that are important to you
This is an open-label phase IV, randomized controlled trial of inactivated poliovirus vaccine (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster dose of fractional IPV (fIPV) in comparison with a full dose of IPV when given after varying IPV and fIPV schedules. Differences in immunogenicity of the varying schedules of IPV and fIPV will also be examined. Concomitantly, immunogenicity to two different rotavirus vaccines will be evaluated.
With the switch from trivalent to bivalent oral poliovirus vaccine (OPV) in 2016, the Global Polio Eradication Initiative (GPEI) is recommending inactivated poliovirus vaccine (IPV) use as one of the potential strategies to respond to outbreaks of type 2 wild type and/or circulating vaccine-derived polioviruses. However, the current global inactivated poliovirus vaccine (IPV; 0.5 mL, full-dose) supply shortage dramatically limits the number of doses available for an effective outbreak response. Therefore, GPEI has proposed use of intradermal administration of a booster of fractional IPV (fIPV; 0.1 mL, one-fifth the full-dose) as a dose-sparing strategy to increase the number of children vaccinated and stretch IPV supplies. No study has compared immunogenicity of a fIPV booster in children previously vaccinated with a single IPV. Furthermore, the IPV shortage has led to reconsideration of fIPV use in routine immunization programs. Previous studies found that in one and two dose head-to-head comparisons, fIPV induced a lower proportion of seroconversion and antibody responses than IPV. However, recent studies of seroconversion and priming suggest two fIPV given at least eight weeks apart may be more immunogenic than one IPV. Because of these findings and the global IPV shortage, the most recent WHO position paper suggests that countries consider administering two fIPV at 6 and 14 weeks of age as an alternative to one IPV after the OPV2 cessation in April 2016. However, no trial has conducted a direct comparison of the immunogenicity of IPV at 14 weeks of age with that of fIPV at 6 and 14 weeks of age.
The immunogenicity of rotavirus (RV) vaccines will also be assessed when given concomitantly with IPV/fIPV. Currently, WHO recommends either of two licensed, live attenuated oral rotavirus vaccines for all children worldwide: the pentavalent RotaTeq (RV5) and monovalent Rotarix (RV1). Many lower income countries where IPV is being introduced are also poised to introduce rotavirus vaccine in the coming years. The first dose of OPV interferes with RV vaccines and RV vaccines may be more immunogenic when delivered with IPV compared with OPV. The proposed study presents an opportunity to compare the two and three dose responses of RV1 and RV5 when delivered with IPV compared with previous studies in Bangladesh when co-administered with OPV.
In addition, recent studies have suggested that host genetic factors (i.e., Secretor and Lewis type) mediate susceptibility to rotavirus infection. More precisely, non-secretors (i.e., children lacking a functional fucosyl transferse-2 [FUT2] gene) have substantially reduced risk of rotavirus infection of certain genotypes. The proposed trial will assess whether Secretor status and Lewis type are also associated with vaccine efficacy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
IPV at 14 and 22 weeks of age, Rotarix, IPV at 14 and 22 weeks of age, RotaTeq, IPV at 14 and fIPV at 22 weeks, Rotarix, IPV at 14 and fIPV at 22 weeks, RotaTeq, IPV at 6 and fIPV at 22 weeks, Rotarix, IPV at 6 and fIPV at 22 weeks, RotaTeq, fIPV at 6-14-
International Center for Diarrhoeal Disease Research, Bangladesh
Not yet recruiting
Centers for Disease Control and Prevention
Published on BioPortfolio: 2016-07-28T03:38:21-0400
This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.
This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotat...
The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy children aged 2 to 6 years in China.
The investigators will assess the usability and immune response following fractional dose inactivated polio virus vaccine (fIPV) administration with two novel intradermal adapters (ID adap...
GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting infants through the Expanded Program on Immunization (EPI) in Mexico. This protocol describe...
This report from the Australian Rotavirus Surveillance Program (ARSP) and collaborating laboratories Australia-wide, describes the rotavirus genotypes identified in children and adults with acute gast...
Feline infectious peritonitis (FIP) is a feline coronavirus (FCoV)-induced fatal disease in wild and domestic cats. There are two FCoV serotypes. Both type I and II FCoV can replicate in Felis catus w...
Docosahexaenoic acid (DHA, 22:6n-3) must be consumed in the diet or synthesized from n-3 polyunsaturated fatty acid (PUFA) precursors. However, the effect of dietary DHA on the metabolic pathway is no...
Optimal management of pregnancies at 39 weeks gestational age is unknown. Therefore, we sought to perform a comparative effectiveness analysis of elective induction of labor (eIOL) at 39 weeks among n...
Isometric exercise training (IET)-induced reductions in resting blood pressure (RBP) have been achieved in laboratory environments, but data in support of IET outside the laboratory are scarce. The ai...
Number of fetal deaths with stated or presumed gestation of 20 weeks or more in a given population. Late fetal mortality is death after of 28 weeks or more.
A term used to describe pregnancies that exceed the upper limit of a normal gestational period. In humans, a prolonged pregnancy is defined as one that extends beyond 42 weeks (294 days) after the first day of the last menstrual period (MENSTRUATION), or birth with gestational age of 41 weeks or more.
A species of CORONAVIRUS infecting cats of all ages and commonly found in catteries and zoos. Cats are often found carrying the virus but only a small proportion develop disease. Feline coronavirus and Feline infectious peritonitis virus (FIPV) are virtually the same virus in genetic and antigenetic terms, and are morphologically indistinguishable. Since they only differ in their disease potential (with FIPV causing a more serious illness), they are considered biotypes of each other.
Documents or charts that show days, weeks, and months of a year.
A species of CORONAVIRUS causing a fatal disease to pigs under 3 weeks old.
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...
Spinal Cord Disorders
The spinal cord is a bundle of nerves that runs down the middle of the back which carry signals back and forth between the body and brain. It is protected by vertebrae, which are the bone disks that make up the spine. An accident that damages the verte...