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Genetic and Environmental Factors in the Response to Influenza Vaccination

NCT03088904 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2020-02-13

No results posted yet for this study

Summary

The purpose of the study is to investigate and compare the immune responses to influenza vaccination in monozygotic (identical) and dizygotic (fraternal) twins to determine the roles of genetics and environment in the response to flu vaccination.

Conditions

Interventions

BIOLOGICAL

FluMist® Quadrivalent

LAIV4 vaccine dosage is 0.2 mL. Vaccine will be administered as an intranasal spray. Each sprayer contains a single dose of FluMist® Quadrivalent; approximately one-half of the contents should be administered into each nostril. 0.1 mL (i.e., half of the dose from a single FluMist sprayer) is administered into each nostril while the recipient is in an upright position. Insert the tip of the sprayer just inside the nose and rapidly depress the plunger until the dose-divider clip stops the plunger. The dose divider clip is removed from the sprayer to administer the second half of the dose (0.1 mL) into the other nostril.

BIOLOGICAL

Fluzone® Quadrivalent vaccine

IIV4 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Mark M Davis, PhD · Stanford School of Medicine, Dept. of Microbiology and Immunology

  • Catherine Blish, MD · Stanford School of Medicine, Dept. of Medicine

  • William Robinson, MD · Stanford School of Medicine, Dept. of Medicine

  • Cornelia Dekker, MD · Stanford School of Medicine, Dept. of Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-03
Primary Completion
2018-12-12
Completion
2018-12-12
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 NCT03088904 on ClinicalTrials.gov