This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits (Visits 1 and 2).
Parent(s) or legal authorized representative(s) (LAR) will assess fever and other solicited systemic adverse events on the day of vaccination (Day 1) and the next 6 days (through Day 7) following Visit 1 and Visit 2 using either a web-based data collection system or a paper memory aid. Serious adverse events and adverse events of special interest will be captured during the entire study period. Parental/LAR perceptions about their child's vaccine schedule will be assessed on Day 7 following Visit 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
344
ACIP Recommended Vaccine
ACIP Recommended Vaccines
Kaiser Permanente Northern California
Oakland, California, United States
Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Number of Participants with Fever Following Vaccination
Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.
Time frame: 2 Days Post-Administration
Number of Participants with Fever Following Visit 1
Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1
Time frame: 2 Days Post Administration
Number of Participants with Fever Following Visit 2
Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2
Time frame: 2 Days Post Administration
Number of Participants with Grade 2 and/or 3 Fever Following Visit 1
Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
Time frame: 2 Days Post Administration
Number of Participants with Grade 2 and/or 3 Fever Following Visit 2
Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
Time frame: 2 Days Post Administration
Number of Participants with Grade 2 and/or 3 Fever Following Visit 1 and Visit 2 Combined
Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
Time frame: 2 Days Post Administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Number of Participants with Medical Care Utilization - Visit 1
Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 1.
Time frame: 2 Days Post Administration
Number of Participants with Medical Care Utilization - Visit 2
Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 2.
Time frame: 2 Days Post Administration
Number of Participants with Medical Care Utilization - Visit 1 and Visit 2 Combined
Number of children with medical care utilization (medical advice (telephone, patient portal), urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and /or day 2 following Visit 1 and Visit 2 combined.
Time frame: 2 Days Post Administration
Number of Participants who Received Antipyretics - Visit 1
Number of children who received antipyretics on day 1 and/or day 2 following Visit 1.
Time frame: 2 Days Post Administration
Number of Participants who Received Antipyretics - Visit 2
Number of children who received antipyretics on day 1 and/or day 2 following Visit 2.
Time frame: 2 Days Post Administration
Number of Participants who Received Antipyretics - Visit 1 and Visit 2 Combined
Number of children who received antipyretics on day 1 and/or day 2 following Visit 1 and Visit 2 combined.
Time frame: 2 Days Post Administration
Number of Participants with Defined Systemic Reactogenicity Events
Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe
Time frame: Up to 7 Days Post Administration
The Number and Percent of Individuals with At Least One Serious Adverse Event
The number and percent of serious adverse events observed and description of each event
Time frame: Up to 105 Days Post Administration