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Inactivated Influenza Vaccine in Infants 10-22 Weeks of Age

NCT00231920 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2011-08-12

No results posted yet for this study

Summary

This study proposes to enroll 50 young infants, ages 10 to 22 weeks. Each of the fifty infants will receive two 0.25mL doses of preservative-free Fluzone®, given a minimum of 28 days apart but no more than 42 days apart. Preservative-free Fluzone® will not be administered at the same time as other routine vaccines. Approximately 2-3mLs of blood sample will be obtained prior to the first vaccination, approximately 4 weeks after the second vaccination and 6 months after the second vaccination for the measurement of immune response. The primary purpose of this study is twofold: 1.) To determine the safety of administering two doses of preservative-free Fluzone® to young infants and 2.) To determine the capability of inducing an immune response of administering two doses of preservative-free Fluzone® to young infants.

Conditions

Interventions

BIOLOGICAL

Fluzone

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Weeks
Max Age
22 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2006-08-31
Completion
2006-10-31

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 NCT00231920 on ClinicalTrials.gov