Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children

NCT02539108 | Completed Phase 4 Results

• 2 other identifiers: GRC58U1111-1161-2526
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The study will evaluate the safety and immunogenicity of the 2015-2016 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 2015-2016 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 2015-2016 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 World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), 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)

• Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine.

  Solicited injection-site reactions for 6 to \< 36 months: Tenderness, Erythema, and Swelling. For 3 to \< 9 years: Pain, Erythema, and Swelling. Solicited systemic reactions for 6 to \< 36 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. For 3 to \< 9 years: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 for 6 to \< 36 months: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Vomiting, 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \> 3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable. Grade 3 for 3 to \< 9 years: Pain, Incapacitating; Erythema and Swelling, ≥ 50 mm; Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, prevents daily activity.

  Day 0 up to Day 7 post any vaccination

Secondary Outcomes (4)

• Geometric Mean Titers of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine

  Day 0 (pre-vaccination) and 28 days post-last vaccination

• Number of Participants Who Achieved Seroprotection to Influenza Virus Antigens Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine

  Day 0 (pre-vaccination) and 28 days post-last vaccination

• Number of Participants Who Achieved Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine

  28 days post-last vaccination

• Geometric Mean Titer Ratios of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine

  Day 0 (pre-vaccination) and 28 days post-last vaccination

Study Arms (2)

Study Group 1

EXPERIMENTAL

Participants at 6 months to \< 36 months age at enrollment

Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative

Study Group 2

EXPERIMENTAL

Participants at 3 years to \< 9 years age at enrollment

Biological: Fluzone® Quadrivalent Influenza Vaccine, No Preservative

Interventions

Fluzone® Quadrivalent Influenza Vaccine, No Preservative BIOLOGICAL

0.25 mL, Intramuscular (Pediatric Dose, 2015 2016 formulation)

Also known as: Fluzone® Quadrivalent, No Preservative

Study Group 1

Eligibility Criteria

• Age: 6 Months - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject is 6 months to \< 9 years of age on the day of first study vaccination (study product administration)
• Subject and parent/guardian 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 guardian 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).

You may not qualify if:

• 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 2015-2016 influenza vaccine
• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Bardstown, Kentucky, 40040, United States

Location

Unknown Facility

Salt Lake City, Utah, 84121, United States

Location

Related Links

• Related Info

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

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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: November 29, 2016
• Results First Posted: October 20, 2016

Record last verified: 2016-10

Locations

US (2)