Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01691326
First received: September 19, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine.

Objective:

  • To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age.

Observational Objectives:

  • To describe the immunogenicity of the 2012-2013 formulation of Fluzone vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to < 9 years of age.
  • To submit remaining available sera from subjects to the Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support selection and recommendation of strains for subsequent years' influenza vaccines.

Condition Intervention Phase
Influenza
Biological: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose
Biological: Fluzone®; Influenza Virus Vaccine, No Preservative
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: Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]

    Solicited injection site reactions (Age 6 to < 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.

    Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, >103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, >3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.

    Solicited injection site reactions (Age 24 Months to < 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

    Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity.



Other Outcome Measures:
  • Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). [ Time Frame: Day 0 (pre-vaccination) and Day 28 after final vaccination ] [ Designated as safety issue: No ]
    The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.

  • Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) [ Time Frame: Day 0 (pre-vaccination) and Day 28 after final vaccination ] [ Designated as safety issue: No ]
    Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).

  • Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation) [ Time Frame: Day 28 after final vaccination ] [ Designated as safety issue: No ]
    Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.

  • Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation). [ Time Frame: Day 0 (pre-vaccination) and Day 28 after final vaccination ] [ Designated as safety issue: No ]
    Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens


Enrollment: 60
Study Start Date: September 2012
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 6 months to < 36 months of age group
Participants at 6 months to < 36 months of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone® (Pediatric Dose).
Biological: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose
0.25 mL dose, Intramuscular
Other Name: Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation
Experimental: 3 years to < 9 years of age group
Participants at 3 years to < 9 years of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone®.
Biological: Fluzone®; Influenza Virus Vaccine, No Preservative
0.5 mL dose, Intramuscular
Other Name: Fluzone® (Influenza Virus Vaccine) 2012 2013 Formulation

Detailed Description:

All participants will receive Fluzone vaccine during Visit 1. For subjects receiving 2 doses of influenza vaccine, per ACIP guidance, a second dose of Fluzone vaccine will be administered during Visit 2.

Total duration of participation in the study is approximately 28 days for participants receiving 1 dose and 56 days for those receiving 2 doses of Fluzone vaccine.

  Eligibility

Ages Eligible for Study:   6 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is 6 months to < 9 years of age on the day of inclusion
  • Parent/guardian is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study
  • Assent form has been signed and dated by subjects 7 to < 9 years of age, and informed consent form has been signed and dated by parent(s) or another legally acceptable representative
  • For subjects 6 months to < 24 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).

Exclusion Criteria:

  • Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information)
  • History of serious adverse reaction to any influenza vaccine
  • Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 for subjects receiving 1 influenza vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine
  • Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study
  • Prior vaccination with any formulation of 2012-2013 influenza vaccine
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator
  • Thrombocytopenia, which may be a contraindication for IM vaccination, at the discretion of the Investigator
  • Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine
  • Personal history of Guillain-Barré syndrome
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
  • Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of immune globulins, blood, or blood-derived products in the past 3 months
  • Identified as a natural or adopted child of the Investigator or an employee with direct involvement in the proposed study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691326

Locations
United States, Kentucky
Bardstown, Kentucky, United States, 40004
United States, Utah
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01691326     History of Changes
Other Study ID Numbers: GRC49, U1111-1124-8218
Study First Received: September 19, 2012
Results First Received: January 24, 2014
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Influenza
Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation
Influenza virus vaccine
Trivalent Inactivated Influenza Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014