Phase 4
N=110
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01306305 ↗Enrolled (actual)
110
Serious AEs
0.9%
Results posted
Mar 2012
Primary outcome: Primary: Seroconversion — 43; 50; 45; 48 Number of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Inflexal V (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Crucell Holland BV
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion |
43; 50; 45; 48; 27; 33 | — |
| PRIMARY Seroprotection |
45; 51; 52; 55; 50; 51 | — |
| PRIMARY Fold Increase in Geometric Mean Titer (GMT) |
25.9; 30.8; 10.6; 14.0; 6.1; 5.7 | — |
| SECONDARY Safety: Numbers of Subjects Reporting Solicited Local Adverse Events |
1; 2; 16; 16; 6; 6 | — |
| SECONDARY Numbers of Subjects Reporting Solicited Systemic Adverse Events |
0; 0; 2; 3; 0; 2 | — |
Summary
A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines
Eligibility Criteria
Inclusion Criteria
- Healthy female and male adults
- Aged ≥18 to ≤60 years or >60 years on Day 1
- Written informed consent
Exclusion Criteria
- Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
- Acute febrile illness (≥38.0 °C)
- Prior vaccination with an influenza vaccine in the past 330 days
- Known hypersensitivity to any vaccine component
- Previous history of a serious adverse reaction to influenza vaccine
- History of egg protein allergy or severe atopy
- Known blood coagulation disorder
- Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
- Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
- Investigational medicinal product received in the past 3 months (90 days)
- Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
- Pregnancy or lactation
- Participation in another clinical trial
- Employee at the investigational site, or relative or spouse of the investigator
- Suspected non-compliance
Data sourced from ClinicalTrials.gov (NCT01306305). 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.