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

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Status and phase

Phase 2
Phase 1




Biological: Influenza virus vaccine (2004-2005 Formulation)

Study type


Funder types



Details and patient eligibility


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.

Full description

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.


394 patients




2 to 9 months old


Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

394 participants in 2 patient groups

Group 1
Experimental group
Participants aged 6 to 12 Weeks at enrollment
Biological: Influenza virus vaccine (2004-2005 Formulation)
Group 2
Experimental group
Participants aged 24 to 36 Weeks at enrollment
Biological: Influenza virus vaccine (2004-2005 Formulation)

Trial contacts and locations



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