Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company ) Identifier:
First received: November 19, 2007
Last updated: January 17, 2014
Last verified: January 2014

To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.

Condition Intervention Phase
Biological: 2007-2008 Influenza Virus Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2007-2008 Formulation)

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation [ Time Frame: Days 0-3 post-dose ] [ Designated as safety issue: Yes ]
    Solicited injection site reactions: Erythema, swelling, pain/tenderness; Solicited systemic reactions: (for infants/toddlers) - fever, irritability, abnormal crying, drowsiness, lost appetite, vomiting; (for children) - fever, headache, malaise, myalgia) Note: Influenza-primed group received only dose 1.

Other Outcome Measures:
  • Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination [ Time Frame: Day 0 and Day 14 after last dose of Fluzone ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) [ Time Frame: Day 14 post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as a serum hemagglutination inhibition antibody titer ≥40.

  • Seroconversion Rates for Each Influenza Antigen Post-Vaccination [ Time Frame: Day 14 post-vaccination ] [ Designated as safety issue: No ]
    Seroconversion was defined as a post-vaccination titer ≥ 40 for participants with a titer < 10 on Day 0 and a ≥4-fold increase for participants with a titer ≥ 10 on Day 0.

Enrollment: 34
Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccine Naive/Inadequately Primed
Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Biological: 2007-2008 Influenza Virus Vaccine
0.25 mL, Intramuscular
Other Name: Fluzone®
Experimental: Influenza Vaccine Primed
Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Biological: 2007-2008 Influenza Virus Vaccine
0.25 mL, Intramuscular
Other Name: Fluzone®


Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Participant is aged ≥ 6 months (24 weeks) to < 36 months (3rd birthday).
  • Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
  • Participant is available for the duration of the study.
  • Parent/legal acceptable representative is willing and able to provide informed consent.
  • Parent/legal acceptable representative is willing and able to meet protocol requirements.
  • Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).

Exclusion Criteria:

  • Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
  • An acute illness with or without fever (For infants/toddlers: temperature ≥ 100.4°F rectal; For children: temperature ≥ 99.5°F oral/axillary) in the 72 hours preceding enrollment in the trial (Enrollment may be deferred).
  • Clinically significant findings in vital signs or review of systems (Investigator judgment; defer or exclude).
  • Participation in any other interventional clinical trial within 30 days prior to enrollment or planned participation in the 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.
  • Known human immunodeficiency virus (HIV)-positive mother.
  • Prior personal 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.
  • Received any vaccinations within the preceding 14 days (enrollment may be deferred).
  Contacts and Locations
Please refer to this study by its identifier: NCT00561002

United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company ) Identifier: NCT00561002     History of Changes
Other Study ID Numbers: GRC38
Study First Received: November 19, 2007
Results First Received: July 20, 2009
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza Vaccine
Influenza Virus
Orthomyxoviridae Infections

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases processed this record on April 17, 2014