Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children

NCT02915302 | Completed Phase 4 Results

• 2 other identifiers: GRC88U1111-1143-9273
• Study Type: interventional
• Target: 1,950
• Locations: 2 countries
• Sites: 36

Brief Summary

The aim of the study was to describe the safety and immunogenicity of a 0.5-mL dose (15 μg hemagglutinin \[HA\] per strain) of Fluzone Quadrivalent vaccine in children 6 to \<36 months of age. Primary objective:

• To compare the rate of any fever (temperature ≥100.4 degrees Fahrenheit \[38.0 degrees Celsius) following a 0.5-mL dose of Fluzone Quadrivalent vaccine to that following a 0.25-mL dose of Fluzone Quadrivalent vaccine during the 7 days after either vaccination (Dose 1 and Dose 2 combined) in participants 6 to \< 36 months of age. Secondary objective:
• To compare antibody responses induced by a 0.5-mL dose of Fluzone Quadrivalent vaccine to those induced by a 0.25-mL dose of Fluzone Quadrivalent vaccine as assessed by geometric mean titer (GMT) ratios and seroconversion rate differences after the final vaccination in participants 6 to \< 36 months of age. Other objectives:
• To describe the safety of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 to \< 36 months of age.
• To describe the immunogenicity of 2 different dose levels of the 2016-2017 formulation of Fluzone Quadrivalent vaccine in participants 6 months to \< 36 months of age.
• To submit available sera from approximately 30 participants to the Center for Biologics Evaluation and Research for further analysis by the World Health Organization, the Centers for Disease Control and Prevention, and the FDA to support formulation recommendations for subsequent influenza vaccines.

Conditions

Influenza

Keywords

Influenza; Influenza virus vaccine; Fluzone® Quadrivalent Influenza Vaccine (No Preservative)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine

  Fever rate was defined as percentage of participants with fever (temperature \>=100.4 degrees Fahrenheit \[38.0 degrees Celsius\]) following vaccination with Fluzone Quadrivalent vaccine.

  Within 7 days after any vaccination

Secondary Outcomes (2)

• Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies

  28 days post-final vaccination

• Percentage of Participants With Seroconversion (Seroconversion Rate [SCR]) to Influenza Vaccine Antigens

  28 days post-final vaccination

Study Arms (2)

Fluzone Quadrivalent Vaccine, 0.25-mL

ACTIVE COMPARATOR

Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.

Biological: Fluzone Quadrivalent vaccine, No Preservative

Fluzone Quadrivalent Vaccine, 0.5-mL

EXPERIMENTAL

Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28.

Biological: Fluzone Quadrivalent vaccine, No Preservative

Interventions

Fluzone Quadrivalent vaccine, No Preservative BIOLOGICAL

0.25-mL (Pediatric Dose), Intramuscular (2016-2017 formulation)

Also known as: Fluzone® Quadrivalent Influenza Vaccine

Fluzone Quadrivalent Vaccine, 0.25-mL

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6 to \< 36 months of age on the day of first study vaccination (study product administration).
• Informed consent form has been signed and dated by the parent(s) or guardian(s).
• Participant and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• Participation at the time of study enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 30 days preceding the first trial vaccination, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine.
• Previous vaccination against influenza (in the 2016-2017 season) with either the trial vaccine or another vaccine.
• Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
• 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).
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial 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.
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial 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 degrees Fahrenheit \[38.0 degrees Celsius\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
• Identified as a natural or adopted child of either the Investigator or an employee with direct involvement in the proposed study.
• History of serious adverse reactions 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 participant 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (36)

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Birmingham, Alabama, 35205, United States

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Harrisburg, Arkansas, 72432, United States

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Downey, California, 90241, United States

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Paramount, California, 90723, United States

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Sacramento, California, 95815, United States

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San Diego, California, 92111, United States

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Thornton, Colorado, 80233, United States

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Miami, Florida, 33142, United States

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Miami Beach, Florida, 33140, United States

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Meridian, Idaho, 83642, United States

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Bardstown, Kentucky, 40004, United States

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Metairie, Louisiana, 70006, United States

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Lincoln, Nebraska, 68504, United States

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Lincoln, Nebraska, 68505, United States

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Lincoln, Nebraska, 68516, United States

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Norfolk, Nebraska, 68701, United States

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Omaha, Nebraska, 68131, United States

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Omaha, Nebraska, 68134, United States

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Syracuse, New York, 13057, United States

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Dayton, Ohio, 45414, United States

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Grove City, Ohio, 43123, United States

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Gresham, Oregon, 97030, United States

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Erie, Pennsylvania, 16505, United States

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Charleston, South Carolina, 29407, United States

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Charleston, South Carolina, 29414, United States

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Tullahoma, Tennessee, 37388, United States

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Fort Worth, Texas, 76107, United States

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Houston, Texas, 77055, United States

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Layton, Utah, 84041, United States

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Orem, Utah, 84057, United States

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Provo, Utah, 84604, United States

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Roy, Utah, 84067, United States

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South Jordan, Utah, 84095, United States

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West Jordan, Utah, 84088, United States

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Burke, Virginia, 22015, United States

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Anaheim, California, 92804, United Kingdom

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Related Publications (1)

• Robertson CA, Mercer M, Selmani A, Klein NP, Jeanfreau R, Greenberg DP. Safety and Immunogenicity of a Full-dose, Split-virion, Inactivated, Quadrivalent Influenza Vaccine in Healthy Children 6-35 Months of Age: A Randomized Controlled Clinical Trial. Pediatr Infect Dis J. 2019 Mar;38(3):323-328. doi: 10.1097/INF.0000000000002227.

  PMID: 30395011 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

800-633-1610

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 27, 2016
• Study Start: September 23, 2016
• Primary Completion: March 6, 2017
• Study Completion: March 6, 2017
• Last Updated: March 29, 2022
• Results First Posted: April 3, 2018

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); US (35)