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PCV13 Dosing Schedule for Pneumococcal Infections
Study Summary
This trial is determining if a reduced dosing schedule of the 13-valent pneumococcal conjugate vaccine is just as effective as the current schedule in Canada.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have long-term kidney problems.You had a severe allergic reaction to any vaccine or its parts, including PCV13 and other regular vaccines.You have long-term liver disease, including cirrhosis.You were born with a problem in your stomach or intestines or had a condition called intussusception in the past.You have diabetes.Criterion: You have a weakened immune system due to various reasons, such as certain medical conditions, medications, or treatments.You have had a confirmed case of pneumococcal disease in the past.You have had a pneumococcal vaccine before.You have untreated tuberculosis.You have a long-term lung condition.You have sickle cell disease or another type of hemoglobin disorder.The mother is taking strong medication that weakens the immune system during pregnancy.You have factors that make you more likely to get sick from pneumococcal disease, according to the Canadian Immunization Guide.You have an ongoing leak of fluid around your brain and spinal cord.You have a long-term neurologic condition that makes it hard to clear saliva from your mouth.You have a cochlear implant, or you are scheduled to get one soon.You have a long-term heart condition.The mother got a pneumococcal vaccine while she was pregnant.A baby born after at least 37 weeks of pregnancy.You must be at least 2 months old but no more than 2 months and 14 days old when you come for your first study visit.
- Group 1: Group 1: 3 doses of PCV13
- Group 2: Group 2: 2 doses of PCV13
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
For which population is this trial meant?
"To be eligible for this study, infants must be between 2 and 2 months old, have a pneumococcal infection, and meet the following additional requirements: be born healthy at ≥37 weeks' gestation, be age 2 months (+ up to 14 days) at time of first study visit, and have a parent or guardian who has given informed consent for their child's participation."
What is PCV13 most often utilized for?
"PCV13 is not only an effective treatment for tetanus, but it can also help patients recover from diphtheria, pneumococcal infections, and other traumas."
Can people who are over the age of 40 years old participate in this research?
"As specified by the inclusion criteria, this clinical trial is only for patients aged 2 Months to 2 Months. Out of the 48 total trials, this is the 22nd one designed for an age group under 18."
Are new participants currently being allowed to join the trial?
"This trial is not accepting patients at the moment. The study was originally posted on 8/23/2018, and the most recent update was on 5/17/2022. However, there are other active studies searching for patients with pneumococcal infections (30 trials) and PCV13 (21 trials)."
Are there other ongoing research projects focusing on PCV13?
"Right now, there are 5 Phase 3 trials and 21 total trials investigating the use of PCV13. Many of these trials are based in Jamaica and New york, but there are 321 clinical trial sites in total."
How large is the pool of potential participants for this clinical trial?
"Unfortunately, this study is no longer enrolling participants. The clinical trial was initially posted on 8/23/2018 and was last updated on 5/17/2022. However, there are other ongoing studies that may be of interest. For example, there are 30 clinical trials actively enrolling participants with pneumococcal infections and 21 studies for PCV13 actively admitting patients."
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