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Fever After Simultaneous Versus Sequential Vaccination in Young Children

NCT03165981 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2024-11-18

Study results available
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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

BIOLOGICAL

PCV13

ACIP Recommended vaccine

BIOLOGICAL

DTaP

ACIP Recommended vaccine

BIOLOGICAL

IIV

ACIP Recommended vaccine

Sponsors & Collaborators

Principal Investigators

  • Emmanuel B Walter, MD, MPH · Duke University

  • Karen Broder, MD · Centers for Disease Control and Prevention

  • Nicola Klein, MD, PhD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
16 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-25
Primary Completion
2018-01-15
Completion
2018-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03165981 on ClinicalTrials.gov