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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01631110
Other study ID # INF-V-A010
Secondary ID
Status Completed
Phase Phase 3
First received June 25, 2012
Last updated December 19, 2013
Start date July 2012
Est. completion date August 2012

Study information

Verified date August 2013
Source Crucell Holland BV
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Inflexal V
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V

Locations

Country Name City State
Switzerland Covance Clinical Research Unit AG Allschwil

Sponsors (1)

Lead Sponsor Collaborator
Crucell Holland BV

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seroprotection 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) Day 22 +/- 2 days No
Primary Seroconversion 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) Day 22 +/- 2 days No
Primary Geometric Mean Titer 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) Day 22 +/- 2 days No
Secondary Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability 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
Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days) Yes
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