Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains
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ClinicalTrials.gov Identifier: NCT01631110 |
Recruitment Status :
Completed
First Posted : June 28, 2012
Results First Posted : December 20, 2013
Last Update Posted : December 20, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Biological: Inflexal V | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 110 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2012/2013-Season Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Elderly subjects aged over 60 years |
Biological: Inflexal V
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
Other Names:
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Experimental: Adults from 18 to 60 years old inclusive |
Biological: Inflexal V
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
Other Names:
|
- Seroprotection [ Time Frame: Day 22 +/- 2 days ]Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
- Seroconversion [ Time Frame: Day 22 +/- 2 days ]Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
- Geometric Mean Titer [ Time Frame: Day 22 +/- 2 days ]GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
- Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability [ Time Frame: Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days) ]
Solicited local and systemic AEs, Unsolicited AEs
Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).
Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4

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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 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

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): NCT01631110
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: | NCT01631110 |
Other Study ID Numbers: |
INF-V-A010 |
First Posted: | June 28, 2012 Key Record Dates |
Results First Posted: | December 20, 2013 |
Last Update Posted: | December 20, 2013 |
Last Verified: | August 2013 |
Influenza Virus Vaccination Inflexal V |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |