Clinical Trial - Fever After Simultaneous Versus Sequential Vaccination in Young Children - Fever

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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.
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