A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere
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ClinicalTrials.gov Identifier: NCT01306253 |
Recruitment Status :
Completed
First Posted : March 1, 2011
Results First Posted : January 20, 2012
Last Update Posted : September 9, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Biological: Inflexal V | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 114 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2009/2010-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Elderly
Elderly subjects aged over 60 years
|
Biological: Inflexal V
Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1 |
Experimental: Adults
Adults from 18 to 60 years old inclusive
|
Biological: Inflexal V
Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1 |
- Seroconversion [ Time Frame: Day 22 ± 2 days ]Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
- Seroprotection [ Time Frame: Day 22 ± 2 days ]Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40
- Fold Increase in Geometric Mean Titer (GMT) [ Time Frame: Day 22/Day 1 ]GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
- Safety: Numbers of Subjects Reporting Solicited Local Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ]Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
- Numbers of Subjects Reporting Solicited Systemic Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ]Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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, 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306253
Switzerland | |
Covance Clinical Research Unit AG | |
Allschwil, Switzerland, 4123 |
Principal Investigator: | Michael Seiberling, MD | Covance Clinical Research Unit AG |
Responsible Party: | Crucell Holland BV |
ClinicalTrials.gov Identifier: | NCT01306253 |
Other Study ID Numbers: |
INF-V-A003 |
First Posted: | March 1, 2011 Key Record Dates |
Results First Posted: | January 20, 2012 |
Last Update Posted: | September 9, 2013 |
Last Verified: | August 2013 |
Influenza Virus Vaccination Immunisation |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |