Annual Study for Serum Collection for Immunogenicity and Safety Evaluation in Healthy Children Receiving Fluzone®

NCT00755274 | Completed Phase 4 Results

• 1 other identifier: GRC40
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To provide the Center for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2008-2009 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study. Observational Objectives: To describe the safety of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with Advisory Committee on Immunization Practices (ACIP) recommendations, in children ≥ 6 months to \< 5 years of age. To describe the immunogenicity of the 2008-2009 pediatric formulation of Fluzone® vaccine, administered in a one- or two-dose schedule in accordance with ACIP recommendations, in children ≥ 6 months to \< 5 years of age.

Conditions

Influenza; Orthomyxoviridae Infections

Keywords

Influenza; Orthomyxoviruses; Orthomyxoviridae Infections; Influenza vaccine

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1

  Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.

  Day 0 to Day 3 post-vaccination 1

• Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2

  Solicited local reactions: Tenderness, pain, erythema, and swelling. Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability, headache, malaise, and myalgia.

  Day 0 to Day 3 post-vaccination 2

Other Outcomes (5)

• Geometric Mean Titers (GMTs) of Antibodies to Vaccine Influenza Strains Determined by Hemagglutination Inhibition (HAI) Assay After Fluzone® Vaccination

  Day 28 post-single dose or Day 21 post-Dose 2

• Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)

  Day 28 post-single dose or Day 21 post-Dose 2

• Percentage of Participants With Influenza Titers ≥ 1:40 After Fluzone® Vaccination (Seroprotection)

  Day 28 post-single dose or Day 21 post-Dose 2

Study Arms (2)

Group 1: Primed

EXPERIMENTAL

Have received 2 or more lifetime Flu Vaccinations Prior to Visit 1

Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose

Group 2: Naive/Inadequately Primed

EXPERIMENTAL

Never Received or Received Only 1 Lifetime Flu Vaccination Prior to Visit 1

Biological: Influenza Virus Vaccine No Preservative: Pediatric Dose

Interventions

Influenza Virus Vaccine No Preservative: Pediatric Dose BIOLOGICAL

0.25 mL, IM (age 6-35 months) or 0.5 mL, IM (age 36-59 months)

Also known as: Fluzone®

Group 1: Primed

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant is ≥ 6 months to \< 5 years of age.
• Participant is considered to be in good health on the basis of reported medical history and a limited history-directed physical examination.
• Parent/legal acceptable representative is willing and able to bring the subject to the scheduled visits and to comply with the study procedures during the entire duration of the study.
• Parent/legal acceptable representative is willing and able to provide informed consent.
• Subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).

You may not qualify if:

• Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
• History of severe adverse event to any influenza vaccine.
• Laboratory-confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment in the study.
• Any vaccination scheduled between Visit 1 and Visit 2.
• Planned participation in any other interventional clinical trial during participation in the study.
• Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
• Personal or immediate family history of congenital immune deficiency.
• Developmental delay, neurologic disorder, or seizure disorder.
• Chronic medical, congenital, or developmental disorder.
• Known Human immunodeficiency virus (HIV)-positive mother.
• Prior personal history of Guillain-Barré syndrome.
• Any condition which, in the opinion of the Investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Norfolk, Virginia, 23510, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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, 2008
• First Posted: September 18, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 14, 2016
• Results First Posted: April 1, 2010

Record last verified: 2016-04

Locations

US (1)