Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

NCT00391391 | Completed Phase 2 Results DMC

• 1 other identifier: FID07
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 19

Brief Summary

Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives:

• To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
• To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

Conditions

Orthomyxoviridae Infection; Influenza; Myxovirus Infection

Keywords

Influenza; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; Infants; children.

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

  Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

  Day 0 and Day 28 post-vaccination

Secondary Outcomes (5)

• Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

  Day 28 post-vaccination

• Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

  Day 28 post-vaccination

• Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine

  Day 28 post-vaccination

• Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.

  Day 0 to Day 7 post-vaccination

• Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds

  Day 0 to Day 7 post-vaccination

Study Arms (4)

1

EXPERIMENTAL

Split, Inactivated, Trivalent Influenza Vaccine

Biological: Split, Inactivated, Trivalent Influenza Vaccine

2

EXPERIMENTAL

Split, Inactivated, Trivalent Influenza Vaccine

Biological: Split, Inactivated, Trivalent Influenza Vaccine

3

ACTIVE COMPARATOR

Split, Inactivated, Trivalent Influenza Vaccine

Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

4

ACTIVE COMPARATOR

Split, Inactivated, Trivalent Influenza Vaccine

Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)

Interventions

Split, Inactivated, Trivalent Influenza Vaccine BIOLOGICAL

Vaccine (infant dose)

1

Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) BIOLOGICAL

Vaccine (infant dose)

Also known as: Fluzone® 2006/2007 Formulation.

3

Eligibility Criteria

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

You may qualify if:

• Subject is healthy, as determined by medical history.
• Institution Review Board (IRB)-approved informed assent form signed by eligible subject (if required by local regulations) and/or an IRB-approved informed consent form signed by the subject's parent(s) or legal representative (and by an independent witness if required by local regulations).
• Parent or legal guardian willing and able to attend (bring subject) to all scheduled visits and comply with all trial procedures.

You may not qualify if:

• Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
• Planned participation in another clinical trial during the present trial period.
• Personal or family history of Guillain-Barré Syndrome.
• Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
• Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a vaccine containing the same substances.
• Chronic illness at a stage that could interfere with trial conduct or completion
• Received blood or blood-derived products in the previous 3 months.
• Any vaccination in the 4 weeks preceding or following the trial vaccinations (Subjects can take standard childhood vaccination(s) following Visit 3 blood draw).
• Known current human immunodeficiency virus (HIV), hepatitis B (HBsAg) or hepatitis C infection or seropositivity.
• Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
• Acute medical illness, with or without fever, within the last 72 hours or an oral temperature ≥ 37.5 °C (99.5 °F) or rectal temperature of ≥ 38°C (100.4 °F) at the time of enrollment.
• History of seizures.
• Received antibiotics therapy within 72 hours preceding the trial vaccination.
• Received any allergy shots in the 7-day period preceding trial vaccination and/or scheduled to receive any allergy shots in the 7-day period after trial vaccination.
• Any condition, which in the opinion of the investigator would pose a health risk to the participant.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (19)

Unknown Facility

Harrisburg, Arkansas, 72432, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

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Trumann, Arkansas, 72472, United States

Location

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Bellflower, California, 90706, United States

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Downey, California, 90241, United States

Location

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Fountain Valley, California, 92708, United States

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Paramount, California, 90723, United States

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Unknown Facility

Owensboro, Kentucky, 42303, United States

Location

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Bossier City, Louisiana, 71111, United States

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Shreveport, Louisiana, 71105, United States

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Brainerd, Minnesota, 56401, United States

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Cleveland, Ohio, 44121, United States

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Erie, Pennsylvania, 16505, United States

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Pittsburgh, Pennsylvania, 15277, United States

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Uniontown, Pennsylvania, 15401, United States

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Wexford, Pennsylvania, 15090, United States

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Fort Worth, Texas, 76107, United States

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Salt Lake City, Utah, 84109, United States

Location

Unknown Facility

Salt Lake City, Utah, 84121, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Orthomyxoviridae Infections; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; 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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2006
• First Posted: October 24, 2006
• Study Start: October 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: October 1, 2007
• Last Updated: December 1, 2011
• Results First Posted: November 22, 2011

Record last verified: 2011-11

Locations

US (19)