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Effect of Age and Prior Immunity on Response to H1N1 Vaccines in Children

NCT01097941 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-09-24

No results posted yet for this study

Summary

A total of 51 children between the ages of 4 and 9 will be randomized to receive a two dose schedule of either licensed live attenuated A/California/07/09 influenza vaccine (LAIV) or licensed inactivated A/California/07/09 influenza vaccine (IIV) or IIV followed by LAIV separated by 28 days. Children with prior vaccination or natural infection with novel H1N1 influenza will be excluded. Randomization will be stratified by pre-existing HAI titers to the previous winter's seasonal H1N1 A/Brisbane/57/07 reference virus.

Conditions

  • 2009 H1N1 Influenza

Interventions

BIOLOGICAL

Live Attenuated H1N1 Influenza Vaccine

0.2 ml dose of live monovalent vaccine delivered through nasal spray, 2 doses given 28 days apart

BIOLOGICAL

Influenza A (H1N1) 2009 Monovalent Vaccine

0.5 ml IM, 2 doses given 28 days apart

BIOLOGICAL

Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live

0.5 ml IM given X1 with 0.1 ml intranasally given 28 days later

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Rochester

    lead OTHER

Principal Investigators

  • John J Treanor, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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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 NCT01097941 on ClinicalTrials.gov