Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Fluzone (2008-2009) Safety and Immunogenicity in Children
NCT00755274Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2008
- Primary completion
- Jan 2009
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- Fluzone Trivalent
- Conditions
- influenza
01
Overview
Phase 4, open-label trial of Fluzone Trivalent in influenza (2 arms), sponsored by Sanofi. Primary endpoints: Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1 and Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2. Started Sep 2008; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Group 1: Primed
Received 2 or more lifetime Flu Vaccinations. Receives 1 dose.
Group 2: Naive/Inadequately Primed
Never Received or Received Only 1 Lifetime Flu Vaccination. Receives 2 doses.
03
Who it enrols
Healthy children aged 6 months to < 5 years born at full term (>= 37 weeks) with birth weight >= 2.5 kg. Excludes children with egg allergy, history of severe reaction to flu vaccine, recent flu infection or vaccination (past 6 months), immunosuppression, HIV-positive mother, history of Guillain-Barré syndrome, or chronic medical conditions.
04
Endpoints
Primary
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 1
Number of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination 2
Beyond the preview
Go deeper on NCT00755274.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00755274.