Phase 4
N=111
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01303510 ↗Enrolled (actual)
111
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Seroconversion — 27; 17; 32; 43 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 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion |
27; 17; 32; 43; 34; 20 | — |
| PRIMARY Seroprotection |
52; 39; 39; 49; 53; 54 | — |
| PRIMARY Fold Increase in Geometric Mean Titer (GMT) |
9.97; 4.36; 11.54; 17.40; 9.90; 2.36 | — |
| SECONDARY Safety: Incidence of Solicited Local Adverse Events |
1; 1; 6; 6; 7; 3 | — |
| SECONDARY Incidence of Solicited Systemic Adverse Events |
0; 0; 8; 3 | — |
Summary
A study to assess whether the Northern Hemisphere 2008/2009 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 study vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; 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 (NCT01303510). 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.