Phase 3
N=440
Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01229371 ↗Enrolled (actual)
440
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Immunogenicity - Geometric Mean Titer Fold Increase From Baseline — 3.5; 4.0; 4.5; 3.4 GMT fold increase
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Inflexal V influenza vaccine (CSL HA Antigen) 2010 (Biological); Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Crucell Holland BV
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity - Geometric Mean Titer Fold Increase From Baseline |
3.5; 4.0; 4.5; 3.4; 2.5; 2.5 | — |
| PRIMARY Immunogenicity - Seroprotection Rate |
99.1; 98.2; 92.7; 90.0; 99.1; 99.1 | — |
| PRIMARY Immunogenicity - Seroconversion Rate |
45.0; 52.7; 54.5; 43.6; 27.5; 29.1 | — |
| SECONDARY Number of Participants With Local and Systemic Adverse Events |
57; 58; 25; 30; 14; 21 | — |
Summary
The purpose of this study is to assess the humoral immune response and safety of the parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly adults, using the EMA (European Medicines Agency) regulation as a guideline.
Eligibility Criteria
Inclusion Criteria
- Healthy female and male adults
- Aged ≥18 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 (including the H1N1 pandemic swine flu 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 spouse and children of the investigator, or relative living in the same household as the investigator and/or are dependent on the investigator
- Suspected non-compliance
Data sourced from ClinicalTrials.gov (NCT01229371). 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.