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Effect of Age and Prior Immunity to Response to Seasonal Influenza Vaccines in Children

NCT01246999 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-12-29

Study results available
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Summary

A total of 88 children between 2 and 9 years of age will be randomized to receive a two dose schedule of either licensed live attenuated trivalent seasonal influenza vaccine (LAIV) or licensed inactivated seasonal influenza vaccine (TIV)or TIV followed by LAIV or LAIV followed by TIV separated by 28 days. Children with a laboratory documented history of prior H1N1 infection will be excluded.

Conditions

Interventions

BIOLOGICAL

Live attenuated Influenza vaccine

0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days

BIOLOGICAL

Trivalent Influenza Vaccine

.25 mL given intramuscularly to children 24 to 36 months of age, 2 doses given 28 days apart, .5 mL given intramuscularly to children 37 months to 9 years of age, 2 doses given 28 day s apart.

BIOLOGICAL

TIV followed by LAIV

TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later

BIOLOGICAL

LAIV followed by TIV

LAIV .2 mL given through nasal spray (.1 mL in each nostril) Followed by TIV .25 mL given intramuscularly to children 24 to 25 months of age or .5 mL given intramuscularly to children 36 months to 9 years of age 28 days later

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Dartmouth-Hitchcock Medical Center

    collaborator OTHER

  • University of Rochester

    lead OTHER

Principal Investigators

  • John J. Treanor, M.D. · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-01-31
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01246999 on ClinicalTrials.gov