Phase 2
Completed N=520
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
Orthomyxoviridae Infection · Influenza · Myxovirus Infection
Source: ClinicalTrials.gov NCT00391391 ↗
Enrolled (actual)
520
Serious AEs
0.8%
Results posted
Nov 2011
Primary outcomePrimary: Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine — 8.9; 9.6; 20.5; 26.9 Titers
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine |
8.9; 9.6; 20.5; 26.9; 58.5; 113.1 | — |
| SECONDARY 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 |
52; 75; 65; 74; 91; 88 | — |
| SECONDARY Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine |
9; 12; 33; 40; 52; 75 | — |
| SECONDARY Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine |
52; 75; 65; 74; 91; 88 | — |
| SECONDARY 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. |
51; 43; 0; 0; 48; 27 | — |
| SECONDARY 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 |
93; 89; 0; 0; 98; 42 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00391391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.