Eligible children will be randomized to receive simultaneous or sequentially administered US licensed PCV13, US-licensed DTaP vaccine, and US-licensed inactivated influenza vaccine (IIV). Children in the simultaneous group will receive PCV13, DTaP, and IIV vaccines at Visit 1, and then return for a health education visit without vaccination about 2 weeks later (Visit 2). Children in the sequential group will receive both PCV13 and DTaP without IIV at Visit 1, and then will receive IIV and health education about 2 weeks later (Visit 2). Parents will record the occurrence of fever, solicited adverse events, medical care utilization, and receipt of antipyretics over 8 days following Visit 1 and Visit 2.
| Study Type: |
Interventional (Clinical Trial) |
| Estimated Enrollment: |
280 participants |
| Allocation: |
Randomized |
| Intervention Model: |
Parallel Assignment |
| Masking: |
None (Open Label) |
| Primary Purpose: |
Prevention |
| Official Title: |
A Prospective, Randomized, Open-label Clinical Trial to Assess Fever Following Simultaneous Versus Sequential Administration of PCV13, DTaP Vaccine and IIV in Young Children |
| Actual Study Start Date: |
August 25, 2017 |
| Estimated Primary Completion Date: |
March 2018 |
| Estimated Study Completion Date: |
March 2018 |
Contact
| Contact: Emmanuel B Walter, MD, MPH |
919-620-5346 |
chip.walter@duke.edu |
| Contact: Christopher A Todd, MPH |
919-681-7791 |
chris.todd@duke.edu |
| ClinicalTrials.gov Identifier: |
NCT03165981 |
For enrollment please visit
www.clinicaltrials.gov.
