N/A
N=110
Re-licensing Study to Assess Virosomal Influenza Vaccine Formulated With WHO Recommended Influenza Strains
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01631071 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Seroprotection — 94.5; 100; 100; 100 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virosomal influenza vaccine (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 |
94.5; 100; 100; 100; 100; 100 | — |
| PRIMARY Seroconversion |
43.6; 58.2; 27.3; 36.4; 34.5; 43.6 | — |
| PRIMARY Geometric Mean Titer |
4.25; 4.62; 2.70; 2.78; 2.78; 3.27 | — |
| SECONDARY Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability |
23; 32; 4; 5; 20; 30 | — |
Summary
The study is to assess whether the virosomal influenza vaccine 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) starting from the first day of the month following the last visit in a previous study
- 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 (NCT01631071). 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.