This is a prospective, randomized, open-label clinical trial to evaluate the safety ofCOVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit1, as compared to sequential vaccination of COVID-19 vaccine and other vaccines atseparate 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.
Biological: mRNA COVID-19 Vaccine
ACIP Recommended Vaccine
Other Name: Pfizer COVID-19 Vaccine, Moderna COVID-19 Vaccine
Biological: Routine Childhood Vaccinations
ACIP Recommended Vaccines
Other Name: Pneumococcal, DTaP, Haemophilus Influenzae Type B, MMR, Varicella, MMRV, Hepatitis A, Inactivated Poliovirus, Hepatitis B, Rotavirus, Influenza vaccines
Inclusion Criteria:
- Child 6 months through <5 years of age at time of enrollment.
- Child is due to receive mRNA COVID-19 vaccine and at least one other routinely
recommended non-live vaccine per CDC or ACIP recommendations.
- Parental/LAR intention of child receiving mRNA COVID-19 vaccine and at least one
recommended non-live vaccine.
- The parent/LAR must be willing and capable of providing permission for their child
to participate through the written informed consent process.
- The parent/LAR must be available for follow-up and must at minimum have telephone
access.
- The parent/LAR must agree to sign a medical release for the child so that study
personnel may obtain medical information about the child's health (if needed).
- The parent/LAR must be willing to delay COVID-19 vaccination for their child for up
to 3 weeks.
- The parent/LAR must be able to read English or Spanish.
Exclusion Criteria:
- History of any seizure (including febrile seizure) or first degree relative
(biologic parent or biologic sibling including half-sibling) with a history of
febrile seizure.
- Contraindication to mRNA COVID-19 vaccine: A history of a severe allergic reaction
(e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine
or a known diagnosed allergy to a component of COVID-19 vaccine.
- A history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or
to a component of a vaccine administered on the day of study enrollment.
- For children receiving DTaP vaccine (alone or combination vaccine): Encephalopathy
(e.g., coma, decreased level of consciousness, prolonged seizures), not attributable
to another identifiable cause, within 7 days of administration of previous dose of
DTP or DTaP.
- Received any other non-live vaccines within 14 days prior to enrollment or any other
live vaccines within 28 days prior to enrollment.
- Intention to receive non-COVID-19 non-live or live vaccines during the 4 weeks after
Visit 1; vaccines may be administered after enrollment if deemed a personal or
public health priority by the health care provider caring for this patient or the
study team.
- Received prior COVID-19 vaccine as part of a clinical trial.
- Received any experimental/investigational agent (vaccine, drug, biologic, device,
blood product, or medication) within 28 days prior to enrollment in this study or
expects to receive an experimental/investigational agent during the study.
- A moderate to severe acute illness and/or a reported temperature ≥ 100.4°F (≥38.0°C)
within 48 hours prior to enrollment or a temperature (measured by temporal artery
thermometer) ≥100.4°F (≥38.0°C) at the time of enrollment. (This may result in a
temporary delay of vaccination).
- Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 72 hours
prior to enrollment (this may result in a temporary delay of vaccination) or planned
receipt of a prophylactic antipyretic medication on the day of and/or days following
vaccination prior to any measured increase in temperature in anticipation of a fever
(this exclusion does not apply if the Parent/LAR indicates they might administer
antipyretics or analgesics after vaccination to reduce a fever or pain).
- Immunosuppression as a result of an underlying illness or treatment, or use of
anti-cancer chemotherapy or radiation therapy since birth.
- Long term (at least 14 days of prednisone 2 mg/kg/day or equivalent other
glucocorticoid) use of any parenteral steroids or high-dose inhaled steroids (>800
mcg/day of beclomethasone dipropionate or equivalent) within the 6 months prior to
enrollment (topical and nasal steroids are allowed).
- Has an active case of COVID-19 infection.
- History of multisystem inflammatory syndrome (MIS-C).
- History of myocarditis or pericarditis.
- Has any condition that would, in the opinion of the site investigator, place the
participant at an unacceptable risk of injury or render the participant unable to
meet the requirements of the protocol.
- Any child or grandchild of a study investigator or study team member.
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
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Michael J Smith, MD
919-684-6335
michael.j.smith@duke.edu
Emily A Randolph, MBA
919-385-5785
emily.randolph@duke.edu
Michael J Smith, MD, Principal Investigator
Duke University