Phase 4
N=347
Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children
Fever After Vaccination · Fever · Seizures Fever
Bottom Line
View on ClinicalTrials.gov: NCT06038617 ↗Enrolled (actual)
347
Serious AEs
0.9%
Results posted
May 2026
Primary outcome: Primary: Number of Participants With Fever Following Vaccination — 14; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- mRNA COVID-19 Vaccine (Biological); Routine Childhood Vaccinations (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Fever Following Vaccination |
14; 10 | — |
| SECONDARY Number of Participants With Fever Following Visit 1 |
13; 4 | 0.0436 sig |
| SECONDARY Number of Participants With Fever Following Visit 2 |
1; 6 | 0.0644 |
| SECONDARY Number of Participants With Grade 2 and/or 3 Fever Following Visit 1 and Visit 2 Combined |
6; 3 | 0.3353 |
| SECONDARY Number of Participants With Grade 2 and/or 3 Fever Following Visit 1 |
5; 0 | — |
| SECONDARY Number of Participants With Grade 2 and/or 3 Fever Following Visit 2 |
1; 3 | 0.3681 |
| SECONDARY Number of Participants With Medical Care Utilization for Fever - Visit 1 and Visit 2 Combined |
0; 0 | — |
| SECONDARY Number of Participants With Medical Care Utilization for Fever - Visit 1 |
0; 0 | — |
| SECONDARY Number of Participants With Medical Care Utilization for Fever- Visit 2 |
0; 0 | — |
| SECONDARY Number of Participants Who Received Antipyretics - Visit 1 and Visit 2 Combined |
24; 19 | 0.5042 |
| SECONDARY Number of Participants Who Received Antipyretics - Visit 1 |
21; 10 | 0.0514 |
| SECONDARY Number of Participants Who Received Antipyretics - Visit 2 |
4; 12 | 0.0367 sig |
| SECONDARY Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old |
117; 118; 6; 6; 2; 0 | — |
| SECONDARY Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old |
122; 114; 1; 1; 0; 1 | — |
| SECONDARY Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old |
40; 38; 2; 2; 0; 0 | — |
| SECONDARY Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old |
38; 32; 0; 3; 1; 2 | — |
| SECONDARY The Number of Individuals With At Least One Serious Adverse Event |
0; 1; 1; 0; 1; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Child 6 months through 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.
Data sourced from ClinicalTrials.gov (NCT06038617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.