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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative (Biological); Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi Pasteur, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.

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.

Clinical Details

Official title: Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 Formulation)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine

Secondary outcome:

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

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

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

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

Detailed description: Participants will be assigned to the appropriate age group (6 months to < 36 months of age or 3 years to < 9 years of age) based on the subject's age at the time of enrollment. Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those subjects receiving 2 doses. Serious adverse event information will be collected from Visit 1 to Visit 2, or Visit 3 for those subjects receiving 2 doses. Immunogenicity will be evaluated in all subjects prior to vaccination on Day 0 (Visit 1) and at Day 28 after the final vaccination using the hemagglutination inhibition technique. For each influenza vaccine strain, pre- and post-vaccination geometric mean titers will be calculated.

Eligibility

Minimum age: 6 Months. Maximum age: 8 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.) Exclusion Criteria:

- 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

- 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

Locations and Contacts

Bardstown, Kentucky 40040, United States

Salt Lake City, Utah 84121, United States

Additional Information

Starting date: September 2013
Last updated: September 17, 2014

Page last updated: August 20, 2015

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