Phase 3
N=110
Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01631110 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Seroprotection — 65.5; 80.0; 98.2; 98.2 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Inflexal V (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Crucell Holland BV
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroprotection |
65.5; 80.0; 98.2; 98.2; 52.7; 70.9 | — |
| PRIMARY Seroconversion |
50.9; 45.5; 18.2; 12.7; 25.5; 41.8 | — |
| PRIMARY Geometric Mean Titer |
5.15; 4.36; 1.96; 1.72; 2.40; 3.33 | — |
| SECONDARY Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability |
25; 35; 10; 10; 17; 33 | — |
Summary
The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.
Eligibility Criteria
Inclusion Criteria
- Healthy female and male adults aged ≥18 on Day 1
- Written informed consent
- Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years
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, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
- Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
- 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 of the investigator
- Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol
Data sourced from ClinicalTrials.gov (NCT01631110). 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.