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Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine

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ClinicalTrials.gov Identifier: NCT02222870
Recruitment Status : Completed
First Posted : August 21, 2014
Results First Posted : October 19, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE August 20, 2014
First Posted Date  ICMJE August 21, 2014
Results First Submitted Date  ICMJE September 16, 2015
Results First Posted Date  ICMJE October 19, 2015
Last Update Posted Date October 19, 2015
Study Start Date  ICMJE August 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine [ Time Frame: Day 0 up to Day 7 post-any injection ]
Solicited Injection-site: 6 to < 36 months - Tenderness, Erythema, and Swelling; 3 to < 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to < 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to < 9 years - Fever, Headache, Malaise, and Myalgia. Grade 3: Fever, > 39.5˚C (6 to < 36 months), ≥ 39.0˚C (3 to < 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2014)
Number of participants reporting solicited injection-site and systemic events and unsolicited adverse events following vaccination with Fluzone® Quadrivalent vaccine. [ Time Frame: Day 0 up to Day 28 post-vaccination ]
Participants 6 Months to < 36 Months of Age: Solicited injection site reactions: Tenderness, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Participants 3 Years to < 9 Years of Age: Solicited injection site reactions: Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Unsolicited adverse events, including serious adverse events will also be collected for all participants.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
  • Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-final vaccination ]
    Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
  • Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-final vaccination ]
    Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.
  • Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine [ Time Frame: Day 28 post-final vaccination ]
    Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.
  • Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine [ Time Frame: Day 28 post-final vaccination ]
    Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2014)
  • Geometric mean titers of antibodies to vaccine antigens following final vaccination with Fluzone® Quadrivalent vaccine [ Time Frame: Day 0 and Day 28 after final vaccination ]
    Immunogenicity will be evaluated prior to vaccination and at 28 days after final vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre- and post-vaccination geometric mean titers (GMTs) will be calculated.
  • Seroprotection with respect to vaccine antigens following vaccination with Fluzone® Quadrivalent vaccine [ Time Frame: Day 0 and Day 28 after final vaccination ]
    Seroprotection is defined as a titer ≥ 40 (l/dil) at pre-vaccination and at Day 28 after the final vaccination.
  • Seroconversion with respect to vaccine antigens following vaccination with Fluzone® Quadrivalent vaccine [ Time Frame: Day 28 after final vaccination ]
    Seroconversion is defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer at Day 28 after the final vaccination.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine
Official Title  ICMJE Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine (2014-2015 Formulation)
Brief Summary

The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age.

Objective:

  • To describe the safety of the 2014-2015 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in children 6 months to < 9 years of age.

Observational objectives:

  • To describe the immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent 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 available sera from each subject to Center for Biologics Evaluation and Research (CBER) for further analysis by the WHO, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
Detailed Description

Participants will be assigned to the appropriate age group based on the age at the time of enrollment. Participants will receive a dose of Fluzone Quadrivalent vaccine, those for whom 2 doses of influenza vaccine are recommended per ACIP guidance, will receive a second dose during Visit 2 (28 days after Visit 1).

Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those subjects receiving 2 doses. Serious adverse event (SAE) information will be collected the study. Immunogenicity will be evaluated in all participants prior to vaccination and at Day 28 after the final vaccination.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
    0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation)
    Other Name: Fluzone® Quadrivalent, No Preservative
  • Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
    0.5 mL, Intramuscular (2014-2015 formulation)
    Other Name: Fluzone® Quadrivalent, No Preservative
Study Arms  ICMJE
  • Experimental: Fluzone Study Group 1
    Participants at 6 months to < 36 months age at enrollment
    Intervention: Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
  • Experimental: Fluzone Study Group 2
    Participants at 3 years to < 9 years of age at enrollment
    Intervention: Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is 6 months to < 9 years of age on the day of first study vaccination (study product administration)
  • Subject and parent/legally acceptable representative are 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 < 9 years of age.
  • For subjects 6 months to < 12 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, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent 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 dose of 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 2014-2015 influenza vaccine.
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
  • Thrombocytopenia, which may be a contraindication for intramuscular 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, 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02222870
Other Study ID Numbers  ICMJE GRC56
U1111-1143-8966 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP