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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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: Emmanuel B Walter, MD, MPH||919-620-5346||[email protected]|
|Contact: Christopher A Todd, MPH||919-681-7791||[email protected]|
For enrollment please visit www.clinicaltrials.gov.