Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children
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.
Timeline
- Start
- 2023-10-30
- Primary completion
- 2025-04-24
- Completion
- 2025-07-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTaP | Vaccine | — | — |
| Subject | Haemophilus influenzae type b | Vaccine | — | — |
| Subject | Hepatitis A | Vaccine | — | — |
| Subject | Hepatitis B | Vaccine | — | — |
| Subject | Inactivated Poliovirus | Vaccine | — | — |
| Subject | Influenza Vaccines | Vaccine | — | — |
| Subject | MMR | Vaccine | — | — |
| Subject | MMRV | Vaccine | — | — |
| Subject | Pneumococcal | Vaccine | — | — |
| Subject | Rotavirus | Vaccine | — | — |
| Subject | Varicella | Vaccine | — | — |
| Subject | mRNA COVID-19 Vaccine | Messenger RNA (mRNA) | — | — |
Indications
No indication recorded.