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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Influenza virus vaccine (2004-2005 Formulation) (Biological); Influenza virus vaccine (2004-2005 Formulation) (Biological)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Sanofi Pasteur, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.


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-naļve 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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With FluzoneĀ® 2004-2005 Pediatric Formulation.

Detailed description: This is an observational and descriptive study that will provide preliminary comparative information about the safety and immunogenicity of FluzoneĀ® 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.


Minimum age: 2 Months. Maximum age: 9 Months. Gender(s): Both.


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 (ā‰„ 36 weeks) with a birth weight ā‰„ 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


- 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


- Previous history of influenza vaccination or documented history of influenza


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

- An acute illness with fever (rectal temperature ā‰„ 38. 0 Ā°C [or ā‰„ 100. 4 Ā°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-BarrƩ 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.

Locations and Contacts

Little Rock, Arkansas 72205, United States

Marietta, Georgia 30062, United States

Durham, North Carolina 27705, United States

Akron, Ohio 44308, United States

Dayton, Ohio 45404, United States

Pittsburgh, Pennsylvania 15241, United States

Norfolk, Virginia 23510, United States

Seattle, Washington 98101, United States

Additional Information

Starting date: April 2005
Last updated: January 16, 2014

Page last updated: August 20, 2015

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