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Covid teen trial

Upstate now seeks participants from 12 to 15 years of age for Pfizer/BioNTech COVID-19 clinical trial

Upstate Medical University is now seeking individuals from ages 12 to 15 to participate in the Pfizer/BioNTech clinical trial evaluating the safety and performance of a potential vaccine against COVID-19. 

Upstate had been conducting the Pfizer/BioNTech trial since late July for individuals 18 to 85. More than 300 individuals have been enrolled in the trial.

The move to lower the trial participant age range from 12 to 15 helps to ensure an effective vaccine for children to prevent them from getting sick and spreading the virus to more vulnerable populations. Siblings of participants who are 16 or 17 can also participate in this phase of the trial.

“Asymptomatic and minimally symptomatic children represent an important reservoir for transmission of several respiratory viruses,” said Joseph Domachowske, MD, professor of pediatrics and microbiology and immunology at Upstate Medical University and Upstate Golisano Children’s Hospital. “A safe and effective vaccine is needed for all ages, including children since those who become infected can easily transmit the virus to others. Those with less serious forms of the infection are still contagious, and since many feel fine, might be more likely to be out and about.”

The efficacy study is a randomized, placebo-controlled, observer-blind study, meaning some individuals in the study will receive a placebo and others a vaccine candidate. The majority of the study team will have no knowledge of which individuals are receiving the placebo or vaccine candidate. 

To be eligible for the study, children and adolescents must be in good health and be able to make a two-year commitment to the study. Volunteers will be required to provide blood samples up to two years after receiving the vaccine/placebo. Individuals might be seen up to ten times during the two-year study period. The two-year time frame for the study is important to assess the safety and long-term immune response. 

Individuals will not incur any expenses for participating in the study. 

Individuals who have previously tested positive for COVID-19 are not eligible to participate in the study. 

During their first two study visits, participants will receive the study vaccine or placebo injection. Nasal swabs to test for COVID-19 will also be collected during these times. During the other study visits to follow, blood samples will be taken. 

For seven days after receiving the placebo/study vaccine, participants will be required to complete a daily e-diary (smart phone application) recording any specific reactions. 

Study visits will take place in the Clinical Research Unit of the Institute for Human Performance on the Upstate campus. 

Individuals interested in participating in the study, can call 315-464-9869 or email trials@upstate.edu for more information. 

The study is being conducted by Upstate’s Institute for Global Health and Translational Science.