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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

Participants aged 6 to 12 Weeks at enrollment

Group Type EXPERIMENTAL

Influenza virus vaccine (2004-2005 Formulation)

Intervention Type BIOLOGICAL

0.25 mL, Intramuscular

Group 2

Participants aged 24 to 36 Weeks at enrollment

Group Type EXPERIMENTAL

Influenza virus vaccine (2004-2005 Formulation)

Intervention Type BIOLOGICAL

0.25 mL, Intramuscular

Interventions

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Influenza virus vaccine (2004-2005 Formulation)

0.25 mL, Intramuscular

Intervention Type BIOLOGICAL

Influenza virus vaccine (2004-2005 Formulation)

0.25 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Fluzone® Preservative-free Fluzone® Preservative-free

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes