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

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ClinicalTrials.gov Identifier: NCT00858468
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : July 31, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza virus vaccine (2004-2005 Formulation) Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : April 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Group 1
Participants aged 6 to 12 Weeks at enrollment
Biological: Influenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
Other Name: Fluzone® Preservative-free

Experimental: Group 2
Participants aged 24 to 36 Weeks at enrollment
Biological: Influenza virus vaccine (2004-2005 Formulation)
0.25 mL, Intramuscular
Other Name: Fluzone® Preservative-free




Primary Outcome Measures :
  1. Percentage of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation. [ Time Frame: Day 0 to Day 7 post-vaccination ]
    Solicited local (injection site) reactions: Tenderness, erythema (redness), and swelling Solicited systemic reactions: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Loss of Appetite, and Irritability.


Other Outcome Measures:
  1. Percentage of Participants With Serum Hemagglutination Inhibition Antibody Titer ≥ 40 Post-vaccination With Fluzone® (Seroprotection). [ Time Frame: 21 days post-vaccination 2 ]

    Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.

    Seroprotection was defined as the percentage of participants with a reciprocal hemagglutination inhibition titers ≥ 40


  2. Percentage of Participants With a Pre-vaccination Serum Hemagglutination Inhibition Antibody Titer of ≤ 10 That Had a Titer of ≥ 40 Post-vaccination With Fluzone® (Seroconversion). [ Time Frame: 21 days post-vaccination 2 ]
    Seroconversion was defined as the percentage of participants with a pre-titer < 1:10 who demonstrated a ≥ 4-fold increases in titer from pre- to post-vaccination.

  3. Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-vaccination With Fluzone® Vaccine. [ Time Frame: 21 days post-vaccination 2 ]
    Data presented for each of the three influenza vaccine virus antigens in the Fluzone® 2004-2005 pediatric formulation.



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Ages Eligible for Study:   2 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858468


Locations
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United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, Georgia
Marietta, Georgia, United States, 30062
United States, North Carolina
Durham, North Carolina, United States, 27705
United States, Ohio
Akron, Ohio, United States, 44308
Dayton, Ohio, United States, 45404
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
United States, Virginia
Norfolk, Virginia, United States, 23510
United States, Washington
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.

Additional Information:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00858468     History of Changes
Other Study ID Numbers: GRC27
First Posted: March 9, 2009    Key Record Dates
Results First Posted: July 31, 2009
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Influenza
Influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs