Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)

NCT ID: NCT01691326

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-02-28

Brief Summary

The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone vaccine.

Objective:

• To describe the safety of the 2012-2013 formulation of Fluzone 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 2012-2013 formulation of Fluzone 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 remaining available 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 selection and recommendation of strains for subsequent years' influenza vaccines.

Detailed Description

All participants will receive Fluzone vaccine during Visit 1. For subjects receiving 2 doses of influenza vaccine, per ACIP guidance, a second dose of Fluzone vaccine will be administered during Visit 2.

Total duration of participation in the study is approximately 28 days for participants receiving 1 dose and 56 days for those receiving 2 doses of Fluzone vaccine.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

6 months to < 36 months of age group

Participants at 6 months to \< 36 months of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone® (Pediatric Dose).

Group Type: EXPERIMENTAL

Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose

Intervention Type: BIOLOGICAL

0.25 mL dose, Intramuscular

3 years to < 9 years of age group

Participants at 3 years to \< 9 years of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone®.

Group Type: EXPERIMENTAL

Fluzone®; Influenza Virus Vaccine, No Preservative

Intervention Type: BIOLOGICAL

0.5 mL dose, Intramuscular

Interventions

Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose

0.25 mL dose, Intramuscular

Intervention Type: BIOLOGICAL

Fluzone®; Influenza Virus Vaccine, No Preservative

0.5 mL dose, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation; Fluzone® (Influenza Virus Vaccine) 2012 2013 Formulation

Eligibility Criteria

Inclusion Criteria

• Subject is 6 months to < 9 years of age on the day of inclusion
• Parent/guardian is 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 < 24 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).

Exclusion Criteria

• Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone 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 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 2012-2013 influenza vaccine
• Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator
• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 8 Years
• 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

Bardstown, Kentucky, United States

Salt Lake City, Utah, United States

Countries

United States

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

U1111-1124-8218

Identifier Type: OTHER

Identifier Source: secondary_id

GRC49

Identifier Type: -

Identifier Source: org_study_id