Duke Leads CDC Study Target 6 Month to Under 5-Year-Old Children–Pfizer mRNA + Simultaneous Childhood Vaccines— Safety Response
Shoutout to Dr. Roger Hodkinson for sharing this important information.
Children aged 6 months to 5 years old are being recruited into a Duke University-led study to determine the safety of simultaneous mRNA COVID-19 vaccine with other childhood vaccines.
A study seeks to assess any adverse reactions when this young cohort are vaccinated both with mRNA COVID-19 vaccines and other standard childhood vaccines such as the Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines.
trialsitenews.com reports:
Young children aged 6 months to 5 years old are being recruited into a Duke University led study to determine the safety of simultaneous mRNA COVID-19 vaccine with other childhood vaccines. TrialSite has gone on the record now for nearly a year raising the issue of safety involving simultaneous vaccination of MRNA COVID-19 vaccines with other childhood vaccines. Now, a study which commenced in September led by Duke in collaboration with several other medical centers seeks to assess any adverse reactions when this young cohort are vaccinated both with mRNA COVID-19 vaccines and other standard childhood vaccines such as the Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines.
Led by Principal Investigator Michael J. Smith, Duke University, other collaborating institutions include the large integrated health delivery system Kaiser Permanente, Columbia University, Children’s Hospital Medical Center in Cincinnati and the Centers for Disease Control and Prevention (CDC).
Michael J. Smith, M.D., Principal Investigator
The Core Study
Starting last month, the study runs for just over a year, concluding December 2024. Involving 600 participants between the ages of 6 months and 5 years of age, a highly vulnerable cohort, this prospective, randomized, parallel assignment clinical trial involves the parent or legal authorized representative (LAR) of the children asses fever and other solicited systemic adverse events on the day of vaccination, known as Day 1, and the next 6 days—meaning through Day 7 after what’s called Visit 1 and Visit 2 using either a web-based data collection system or a paper memory aid.
The goal here of course is to capture any serious adverse events during this study period. The study was designed to include the assessment of parental/LAR perceptions about their child’s vaccine schedule by Day 7, after Visit 2.
The study includes two arms, including the following:
Nelle's journey 