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Hepatitis B Vaccine* [Recombinant] *as applicable for Pneumococcal Vaccination
Study Summary
This trial is testing the safety and efficacy of two pneumococcal vaccines in infants and toddlers.
- Pneumococcal Vaccination
- Hepatitis B Vaccination
- Pertussis Vaccination
- Diphtheria Vaccination
- Tetanus Vaccine
- Mumps Vaccination
- Haemophilus Influenzae Type b Vaccination
- Polio Vaccination
- Measles Vaccination
- Rubella Vaccination
- Chickenpox Vaccine
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?
Frequently Asked Questions
Is this experiment actively enrolling test subjects?
"Correct. On clinicaltrials.gov, it is apparent that this medical trial has commenced its recruitment process since May 22nd 2020 and was last updated on October 14th 2022. Approximately 840 participants need to be recruited from 93 distinct sites."
Am I eligible to be involved in this experiment?
"This trial is recruiting 840 infants, aged 42 days to 15 months old, who have already contracted diphtheria. Necessary requirements include attending all scheduled sessions and adhering to the protocol as well being born at full term with a birthweight of 5.5 pounds or greater; receiving 3 doses of Prevnar 13 and other DTaP-IPV/Hib antigens prior to enrolment; and being between 12 -15 months on the day of their first visit OR 42 -89 days on that same date."
Are there any prior studies involving the Hepatitis B Vaccine [Recombinant], if applicable?
"The initial research on Hepatitis b Vaccine* [Recombinant] *as applicable was conducted in 2007 at Children's Hospital of Geneva (HUG). Subsequently, 844 studies were completed with 77 additional trials currently ongoing. Notably, Missoula, Montana is a major hub for these investigations."
To what ailments is the Hepatitis B Vaccine* [Recombinant] *as applicable typically prescribed for?
"The Hepatitis b Vaccine* [Recombinant] *as applicable is primarily used to target mumps, but can also be utilized in the treatment of human poliovirus 1, poliomyelitis, and gastroenteritis."
Are there numerous US venues hosting this research project?
"There are a plethora of clinical trial locations available, including Boeson Research-Site Number:8400004 in Missoula, Lincoln Pediatric Group-Site Number:8400125 in Lincoln and Investigational Site Number :8400137 in Annapolis. Altogether there are 93 sites for this study."
Does the FDA sanction the use of Recombinant Hepatitis B Vaccine?
"Due to a lack of efficacy data, our team at Power has assigned the Hepatitis b Vaccine* [Recombinant] *as applicable a safety score of 2. This is based on it being in Phase 2 clinical trials and having some supporting evidence for its safety profile."
What are the primary aims of this experiment?
"This study's primary objective, assessed around Day 30 of the trial, is to identify how many participants present with injection site and systemic reactions. There are also two secondary objectives - evaluating the geometric mean (GM) ratio for serotype specific opsonophagocytic titers in both toddlers and infants as well as determining how many infants have a serotype-specific OPA titer above a predefined threshold value."
Is the age limit for participation in this research project restricted to below 35 years of age?
"This research initiative is accepting patients aged between 42 days and 15 months old. There are 61 studies for minors, and 180 trials for senior citizens."
How many participants are taking part in this research trial?
"Affirmative. Information present on clinicaltrials.gov indicates that this examination is in the process of recruiting participants, having first been posted on May 22nd 2020 and last modified October 14th 2022. The trial requires 840 people to be recruited from 93 distinct sites."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Investigational Site Number :8400066: < 24 hours
Average response time
- < 1 Day
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