NCT03165981

Fever After Simultaneous Versus Sequential Vaccination in Young Children

A Prospective, Randomized, Open-label Clinical Trial to Assess Fever Following Simultaneous Versus Sequential Administration of PCV13, DTaP Vaccine and IIV in Young Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 12 Months – 16 Months
• Healthy volunteers: Accepted

Summary

A prospective, randomized open-label clinical trial that will be conducted during the 2017-2018 influenza season. During the 2017-2018 season, approximately 280 children will be enrolled at Duke University Medical Center and Kaiser Permanente Northern California. 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. In addition, febrile seizures and serious adverse events will be recorded for the entire study period (from enrollment through 8 days following the Visit 2) as determined through parental report and chart review. Parental perceptions about their child's vaccine schedule will be assessed on the 8th day following Visit 2.

Conditions

• Fever After Vaccination
• Fever
• Febrile Seizure

Interventions

Type	Name	Description
BIOLOGICAL	PCV13	ACIP Recommended vaccine
BIOLOGICAL	DTaP	ACIP Recommended vaccine
BIOLOGICAL	IIV	ACIP Recommended vaccine

Timeline

• Start date: 2017-08-25
• Primary completion: 2018-01-15
• Completion: 2018-01-15
• First posted: 2017-05-24
• Last updated: 2024-11-18
• Results posted: 2019-02-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study