Pfizer-Biotech clinical trial to further evaluate its BNT162b2 COVID-19 vaccine in children aged 6 months to 11 years. Novavax clinical trial to assess NVX-CoV2373 for the prevention of COVID-19 in 12-17-year-old adolescents.
COLUMBUS, OH, May 05, 2021 /24-7PressRelease/ — Aventiv Research, a leading independent, multi-therapeutic inpatient and outpatient clinical research center, announced today it will begin enrolling patients to evaluate the safety and effectiveness of two new pediatric COVID-19 vaccine studies. “Children are the largest group of our population that are now getting infected with the coronavirus and it is our responsibility to get them vaccinated as soon as possible,” said Dr. Samir Arora, President & Medical Director of Aventiv Research. “Aventiv was one of the largest centers involved in the Pfizer adult vaccine study and is very proud to now bring these two pediatric studies to the Columbus community.”
Participants in the studies will be seen at Aventiv’s main clinical pharmacology site located in Columbus at 99 N. Brice Road, Suite 260, neighboring Mount Carmel East. The research center has a dedicated vaccine unit, private exam rooms, comfortable patient lounge, and free parking.
Pfizer-Biotech Pediatric Vaccine Development
Pfizer-Biotech recently provided an update on the Phase 1/2/3 study of BNT162b2 in children aged 6 months to 11 years of age. The study is evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule in three age groups: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years. Participants will randomly receive either the vaccine candidate or placebo in two doses, administered 21 days apart.
The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.
Novavax Adolescent Vaccine Development
Novavax, a biotechnology company developing next-generation vaccines for serious infectious diseases, recently announced that it has initiated a pediatric expansion of its Phase 3 clinical trial for NVX-CoV2373, the company’s recombinant protein vaccine candidate against COVID-19. The additional arm of the ongoing PREVENT-19 pivotal trial will evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 in adolescents aged 12-17. Participants will randomly receive either the vaccine candidate or placebo in two doses, administered 21 days apart.
For more information about Aventiv Research, visit https://www.aventivresearch.com.
About Aventiv Research
Aventiv Research exists to make novel medicines accessible to its patients and deliver industry-best pharmaceutical data to its sponsors. Its mission is to enrich the lives of both its team members and patients by putting medical research to work. Currently operating in two states with four independent research sites, Aventiv specializes in phase I-IV pharmaceutical, device, and diagnostic clinical trials in a variety of therapeutic areas. Built on the core values of dedication, integrity, resourcefulness, and professionalism, the company embraces a visionary, entrepreneurial spirit that compels its ambassadors to blaze new trails with proprietary systems and processes.
Founded in 2007 by Dr. Samir Arora, a proven leader with more than 15 years of clinical research experience, Aventiv Research has conducted over 450 clinical trials with more than 55 pharmaceutical sponsors and has helped 16 drugs to become approved by the FDA and available for use.
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