NCT00391391CompletedPhase 2
Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone® in Healthy Infants and Young Children.
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 520
- Locations
- 19
- Primary Endpoint
- Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 6 months to 8 years but not yet 9 years on the day of inclusion.
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
3
Active Comparator
Split, Inactivated, Trivalent Influenza Vaccine
Intervention: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) (Biological)
4
Active Comparator
Split, Inactivated, Trivalent Influenza Vaccine
Intervention: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) (Biological)
2
Experimental
Split, Inactivated, Trivalent Influenza Vaccine
Intervention: Split, Inactivated, Trivalent Influenza Vaccine (Biological)
1
Experimental
Split, Inactivated, Trivalent Influenza Vaccine
Intervention: Split, Inactivated, Trivalent Influenza Vaccine (Biological)
Outcomes
Primary Outcomes
Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Time Frame: Day 0 and Day 28 post-vaccination
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Secondary Outcomes
- 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)
Investigators
Study Sites (19)
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