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

NCT01946425 | Completed Phase 4 Results

• 2 other identifiers: GRC51U1111-1120-1262
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to evaluate the safety and immunogenicity of Fluzone® Quadrivalent vaccine in participants aged 6 months to \< 9 years at enrollment, divided into 2 age strata (6 months to \< 36 months and 3 years to \< 9 years) Primary Objective:

• To describe the safety of the 2013-2014 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to \< 9 years of age. Observational Objectives:
• To describe the immunogenicity of the 2013-2014 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 sera from subjects to the 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 Food and Drug Administration (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 or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine

  Solicited injection-site reactions (6 months to \<36 months of age): Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite loss, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥50 mm; Fever, \>103.1ºF; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness, Sleeping most of the time; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable. Solicited injection-site reactions (3 years to \< 9 years of age): Pain, Erythema, and Swelling. Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm; Fever, ≥102.1ºF; Headache, Malaise, and Myalgia, Significant, prevents daily activity.

  Day 0 up to Day 7 post-vaccination

Secondary Outcomes (4)

• Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine

  Day 0 (pre-vaccination) and Day 28 after final vaccination

• Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine

  Day 0 (pre-vaccination) and Day 28 after final vaccination

• Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine

  Day 0 (pre-vaccination) and Day 28 after final vaccination

• Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine

  Day 0 (pre-vaccination) and Day 28 after final vaccination

Study Arms (2)

Age 6 Months to <36 Months (Study Group 1)

EXPERIMENTAL

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

Biological: Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative

Age 3 Years to <9 Years Group (Study Group 2)

EXPERIMENTAL

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

Biological: Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative

Interventions

Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative BIOLOGICAL

0.25 mL, Intramuscular (Pediatric Dose, 2013-2014 formulation)

Also known as: Fluzone® Quadrivalent, No Preservative

Age 6 Months to <36 Months (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/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 \< 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 2013-2014 influenza vaccine
• Thrombocytopenia, which may be a contraindication for IM 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 (HIV), 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: September 16, 2013
• First Posted: September 19, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: July 1, 2014
• Last Updated: September 25, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

US (2)