Phase 3
N=3,325
Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00383123 ↗Enrolled (actual)
3,325
Serious AEs
—
Results posted
Dec 2008
Primary outcome: Primary: Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies — 52.4; 101.4; 80.5; 218.0 Titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluarix™ (Biological); Fluzone (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies |
52.4; 101.4; 80.5; 218.0; 20.2; 40.6 | — |
| PRIMARY Number of Seroconverted Subjects |
105; 179; 117; 190; 48; 114 | — |
| PRIMARY Number of Subjects Reporting Rare Serious Events |
11; 11 | — |
| SECONDARY Number of Seroprotected Subjects |
15; 16; 122; 193; 39; 44 | — |
| SECONDARY Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer |
125; 117; 114; 173; 74; 129 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and General Symptoms |
1072; 526; 31; 19; 421; 233 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events |
700; 458; 102; 62; 112; 75 | — |
| SECONDARY Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) |
11; 3; 11; 11 | — |
Summary
The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion Criteria
- A male or female child age 6 months to 10 years.
- Female subjects of childbearing potential must agree to take a pregnancy test.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
- History of hypersensitivity to any vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrollment.
- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Pregnant or lactating female.
- Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.
Data sourced from ClinicalTrials.gov (NCT00383123). 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.