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Immunologic Response to Influenza Vaccination in Children and Adolescents

NCT03614975 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2020-01-18

Study results available
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Summary

The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot).

Conditions

  • Influenza, Human
  • Immune Response

Interventions

BIOLOGICAL

Flucelvax inactivated influenza vaccine

Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)

BIOLOGICAL

Fluzone inactivated influenza vaccine

Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)

Sponsors & Collaborators

Principal Investigators

  • Richard K Zimmerman, MD, MPH, MA · University of Pittsburgh, School of Medicine, Dept. Family Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-13
Primary Completion
2018-12-13
Completion
2018-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03614975 on ClinicalTrials.gov