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

NCT ID: NCT02915302

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1950 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-23
• Study Completion Date: 2017-03-06

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.

Detailed Description

All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine during Visit 1. For participants, for whom 2 doses of influenza vaccine were recommended per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone Quadrivalent vaccine (of the same volume as the first dose) was administered during Visit 2 (28 days after Visit 1).

Solicited adverse event (AE) information was collected for 7 days after each vaccination, unsolicited AE information was collected from Visit 1 to Visit 2 or to Visit 3 for participants receiving 2 doses of study vaccine. Serious adverse event (SAE) information was collected for 28 days after each vaccination.

Immunogenicity was evaluated in a planned subset of 1600 randomly selected participants prior to vaccination on Day 0 (Visit 1) and at Day 28 after the final vaccination.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Fluzone Quadrivalent Vaccine, 0.25-mL

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.

Group Type: ACTIVE_COMPARATOR

Fluzone Quadrivalent vaccine, No Preservative

Intervention Type: BIOLOGICAL

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

Fluzone Quadrivalent Vaccine, 0.5-mL

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.

Group Type: EXPERIMENTAL

Fluzone Quadrivalent vaccine, No Preservative

Intervention Type: BIOLOGICAL

0.5-mL, Intramuscular (2016-2017 formulation)

Interventions

Fluzone Quadrivalent vaccine, No Preservative

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

Intervention Type: BIOLOGICAL

Fluzone Quadrivalent vaccine, No Preservative

0.5-mL, Intramuscular (2016-2017 formulation)

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone® Quadrivalent Influenza Vaccine; Fluzone® Quadrivalent Influenza Vaccine

Eligibility Criteria

Inclusion Criteria

• Aged 6 to < 36 months of age on the day of first study vaccination (study product administration).
• Born at full term of pregnancy (≥37 weeks) and/or with a birth weight ≥2.5 kg. Note: This inclusion criterion only applies to participants 6 to <12 months of age on the day of the first study visit.
• 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.

Exclusion Criteria

• 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.
• 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.
• 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.
• Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Birmingham, Alabama, United States

Harrisburg, Arkansas, United States

Downey, California, United States

Paramount, California, United States

Sacramento, California, United States

San Diego, California, United States

Thornton, Colorado, United States

Miami, Florida, United States

Miami Beach, Florida, United States

Meridian, Idaho, United States

Bardstown, Kentucky, United States

Metairie, Louisiana, United States

Lincoln, Nebraska, United States

Lincoln, Nebraska, United States

Lincoln, Nebraska, United States

Norfolk, Nebraska, United States

Omaha, Nebraska, United States

Omaha, Nebraska, United States

Syracuse, New York, United States

Dayton, Ohio, United States

Grove City, Ohio, United States

Gresham, Oregon, United States

Erie, Pennsylvania, United States

Charleston, South Carolina, United States

Charleston, South Carolina, United States

Tullahoma, Tennessee, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Layton, Utah, United States

Orem, Utah, United States

Provo, Utah, United States

Roy, Utah, United States

South Jordan, Utah, United States

West Jordan, Utah, United States

Burke, Virginia, United States

Anaheim, California, United Kingdom

Countries

United States; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30395011 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1143-9273

Identifier Type: OTHER

Identifier Source: secondary_id

GRC88

Identifier Type: -

Identifier Source: org_study_id