Inactivated Influenza Vaccine in Infants 10-22 Weeks of Age

NCT00231920 | Completed Phase 1

• 1 other identifier: 04-057
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief 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

Influenza

Keywords

Influenza, Vaccine, Infants

Interventions

Fluzone BIOLOGICAL

Eligibility Criteria

• Age: 10 Weeks - 22 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants, 10-22 weeks of age
• Up to date with routine immunizations (Hepatitis B \[Hep B\]; diphtheria, tetanus and pertussis \[DTaP\]; pneumococci \[Prevnar\]; polio \[IPV\]; Haemophilus influenzae type B \[Hib\])
• Free of obvious health problems as established by medical history and clinical examination before entering into the study
• Parent/legal guardian willing and capable of signing written informed consent
• Parent/legal guardian expected to be available for entire study
• Parent/legal guardian can be reached by telephone.

You may not qualify if:

• History of hypersensitivity to eggs or egg proteins
• Former premature infants (\<37 weeks)
• History of wheezing or use of bronchodilator medication
• History of hospitalization (excluding birth)
• Significant underlying chronic illness (i.e. congenital heart defect, bronchopulmonary dysplasia, HIV)
• Immunodeficiency disease or use of immunosuppressive therapy by the participant
• Any other condition which in the clinical judgment of the investigator might interfere with vaccine evaluation
• Current enrollment and participation in a clinical trial for an investigational drug or vaccine
• Plans for participation in another clinical trial with an investigational drug or vaccine for the duration of this flu study.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-2573, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: October 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: October 1, 2006
• Last Updated: August 12, 2011

Record last verified: 2006-11

Locations

US (2)