ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    GRC90
Previous Study | Return to List | Next Study

Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations (GRC90)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03617523
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The primary objectives of this study are:

  • To describe the immunogenicity of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to < 36 months of age and 3 to < 9 years of age, and in adults 18 to < 65 years of age, the immunogenicity of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to < 65 years of age, and the immunogenicity of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.
  • To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in children 6 to < 36 months of age and 3 to < 9 years of age, and in adults 18 to < 65 years of age, the safety of the 2018-2019 formulation of Flublok Quadrivalent vaccine in adults 18 to < 65 years of age, and the safety of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults ≥ 65 years of age.

Condition or disease Intervention/treatment Phase
Influenza Biological: Fluzone Quadrivalent vaccine, 2018-2019 formulation Biological: Flublok Quadrivalent vaccine, 2018-2019 formulation Biological: Fluzone High-Dose vaccine, 2018-2019 formulation Phase 4

Detailed Description:
Study duration per participant will be approximately 28 days for participants receiving one dose of vaccine and 56 days for participants receiving two doses of vaccine.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is partially randomized. Subjects are assigned a vaccine group based on age. Groups 1, 2 and 5 are not randomized, while Groups 3 and 4 are randomized.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Fluzone Quadrivalent vaccine Group 1: 6 to < 36 months
Fluzone Quadrivalent vaccine: pediatric dose containing 7.5 µg/HA of each antigen per 0.25-mL dose. For participants for whom 2 doses of influenza vaccine are recommended, a second dose will be administered on Day 28.
Biological: Fluzone Quadrivalent vaccine, 2018-2019 formulation
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Experimental: Fluzone Quadrivalent vaccine Group 2: 3 to < 9 years
Fluzone Quadrivalent vaccine: 15 µg/HA of each antigen per 0.5-mL dose. For participants for whom 2 doses of influenza vaccine are recommended, a second dose will be administered on Day 28.
Biological: Fluzone Quadrivalent vaccine, 2018-2019 formulation
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Experimental: Fluzone Quadrivalent vaccine Group 3: 18 to < 65 years
Fluzone Quadrivalent vaccine. 15 µg/HA of each antigen per 0.5-mL dose
Biological: Fluzone Quadrivalent vaccine, 2018-2019 formulation
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Experimental: Flublok Quadrivalent vaccine Group 4: 18 to < 65 years
Flublok Quadrivalent vaccine. 45 µg/HA of each antigen per 0.5-mL dose
Biological: Flublok Quadrivalent vaccine, 2018-2019 formulation
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Experimental: Fluzone High-Dose vaccine Group 5: ≥ 65 years
Fluzone High-Dose vaccine (subjects ≥ 65 years of age): 60 µg/HA of each antigen per 0.5-mL dose
Biological: Fluzone High-Dose vaccine, 2018-2019 formulation
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular




Primary Outcome Measures :
  1. Number of Participants Reporting Solicited Injection Site Reactions or Systemic Reactions [ Time Frame: Within 7 days post-vaccination ]

    Injection site reactions for all participants: tenderness/pain, erythema, and swelling.

    Systemic reactions for participants < 36 months: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability. For participants 3 years and older: fever, headache, malaise, and myalgia.


  2. Summary of Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to < 9 Years of Age Receiving Fluzone Quadrivalent Vaccine [ Time Frame: 28 days post-final vaccination ]
    GMTs will be assessed using a hemagglutination inhibition (HAI) assay

  3. Summary of GMTs of Antibodies in Adults Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent vaccine, or Fluzone High-Dose Vaccine [ Time Frame: Day 21 (post- vaccination) ]
    GMTs will be assessed using an HAI assay

  4. GMT Ratios of Antibodies in Children 6 Months to < 9 Years of Age Receiving Fluzone Quadrivalent Vaccine [ Time Frame: 28 days post-final vaccination ]
    GMT ratios will be assessed using an HAI assay

  5. GMT Ratios of Antibodies in Adults Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent vaccine, or Fluzone High-Dose Vaccine [ Time Frame: Day 21 (post- vaccination) ]
    GMT ratios will be assessed using an HAI assay

  6. Seroprotection Rates in Children 6 Months to < 9 Years of Age Receiving Fluzone Quadrivalent Vaccine [ Time Frame: 28 days post-final vaccination ]
    Seroprotection will be assessed using an HAI assay. Seroprotection is defined as a titer ≥ 40 (1/dil) at pre-vaccination and at post-vaccination

  7. Seroprotection Rates in Adults Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent vaccine, or Fluzone High-Dose Vaccine [ Time Frame: Day 21 (post- vaccination) ]
    Seroprotection will be assessed using an HAI assay. Seroprotection is defined as a titer ≥ 40 (1/dil) at pre-vaccination and at post-vaccination

  8. Seroconversion Rates in Children 6 Months to < 9 Years of Age Receiving Fluzone Quadrivalent Vaccine [ Time Frame: 28 days post-final vaccination ]
    Seroconversion will be assessed using an HAI assay. 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

  9. Seroconversion Rates in Adults Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent vaccine, or Fluzone High-Dose Vaccine [ Time Frame: Day 21 (post- vaccination) ]
    Seroconversion will be assessed using an HAI assay. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria :

  • Aged 6 months to < 9 years or ≥ 18 years on the day of first study vaccination (study product administration).
  • For subjects 6 to < 12 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).
  • Informed consent form (ICF) has been signed and dated by subjects ≥ 18 years of age
  • Assent form has been signed and dated by subjects 7 to < 9 years of age, and ICF has been signed and dated by parent(s) or guardian(s) for subjects 6 months to < 9 years of age.
  • Subject and parent/guardian (of subjects 6 months to < 9 years of age) are able to attend all scheduled visits and to comply with all study procedures

Exclusion criteria:

  • Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
  • Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
  • Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 2 for subjects receiving 1 dose of influenza vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine.
  • Previous vaccination against influenza (in the 2018-2019 influenza season) with either study vaccine or another vaccine.
  • Receipt of immune globulins, blood, or blood-derived products in the 3 months preceding planned inclusion.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the 6 months preceding planned inclusion; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the 3 months preceding planned inclusion).
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life- threatening reaction to study vaccine or to a vaccine containing any of the same substances.
  • Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Current alcohol abuse or drug addiction.
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of planned vaccination or febrile illness (temperature ≥ 100.4 F [38.0oC]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study (subjects ≥ 18 years of age) or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study (all subjects).
  • History of serious adverse reaction to any influenza vaccine.
  • Personal history of Guillain-Barré Syndrome.
  • 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 clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
  • Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT03617523


Contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # RegistryContactUS@sanofipasteur.com

Locations
United States, Kentucky
Investigational Site Number 8400003 Recruiting
Bardstown, Kentucky, United States, 40004
United States, Louisiana
Investigational Site Number 8400001 Recruiting
Metairie, Louisiana, United States, 70006
United States, Utah
Investigational Site Number 8400002 Active, not recruiting
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company

Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03617523     History of Changes
Other Study ID Numbers: GRC90
U1111-1211-4864 ( Other Identifier: UTN )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs