Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:April 2005
End Date:December 2006

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Proof of Concept Study of the Safety and Immunogenicity of Influenza Virus Vaccine Fluzone® 2004-2005 Among Healthy Children 2 Months vs 6 Months of Age

Primary Objective:

To describe the safety of the 2004-2005 pediatric formulation of the inactivated,
split-virion influenza vaccine Fluzone®, given in the two-dose schedule (described in the
package insert for vaccine-naïve young children) to the investigational and control groups.

Observational Objective:

To describe the percentage of protective Hemagglutination Inhibition (HAI) antibody titers
(following a 2-dose Fluzone® immunization series) to each of the 3 vaccine antigens among
the investigational and control groups.

This is an observational and descriptive study that will provide preliminary comparative
information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to
12 weeks (the investigational group, also referred to as the 2-month-old group) versus
children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group).
The study is not designed to achieve any preset statistical power, and no hypotheses will be
tested.

Inclusion Criteria :

- Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.

- Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.

- Considered to be in good health on the basis of reported medical history and
history-directed physical examination.

- Available for the duration of the study.

- Parent/guardian willing and able to provide informed consent.

- Parent/guardian able to attend all scheduled visits and comply with all trial
procedures.

- Willingness to permit venipuncture or heel stick for purposes of collecting a blood
sample.

Exclusion Criteria :

- Reported allergy to egg proteins, chicken proteins or any other constituent of the
vaccine.

- Previous history of influenza vaccination or documented history of influenza
infection.

- Receipt of any vaccine in the 7 days prior to enrollment.

- An acute illness with fever (rectal temperature ≥ 38.0 °C [or ≥ 100.4 °F]) in the 72
hours preceding enrollment in the trial (defer enrollment).

- Known bleeding disorder.

- Participation in any other clinical trial within 30 days prior to enrollment, or
planned participation in another clinical trial prior to termination of the subject's
participation in this study.

- Known or suspected impairment of immunologic function or receipt of immunosuppressive
therapy or immunoglobulin since birth.

- Personal or immediate family history of congenital immune deficiency.

- Developmental delay, neurologic disorder, or seizure disorder.

- Chronic medical, congenital or developmental disorder that could interfere with trial
conduct or completion.

- Known HIV-positive or HBsAg-positive mother.

- Known HIV, hepatitis B (HBsAg), or hepatitis C infection.

- Blood or blood-derived products received in the past 2 months.

- Prior history of Guillain-Barré syndrome.

- Any condition which, in the opinion of the investigator, would pose a health risk to
the subject or interfere with the evaluation of the vaccine.
We found this trial at
8
sites
2040
mi
from 91732
Akron, OH
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1897
mi
from 91732
Dayton, OH
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2202
mi
from 91732
Durham, NC
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1463
mi
from 91732
Little Rock, AR
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1908
mi
from 91732
Marietta, GA
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2336
mi
from 91732
Norfolk, VA
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2119
mi
from 91732
Pittsburgh, PA
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964
mi
from 91732
Seattle, WA
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