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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01412281
Other study ID # ADD-V-A002
Secondary ID
Status Completed
Phase Phase 3
First received August 8, 2011
Last updated August 29, 2013
Start date October 2011
Est. completion date December 2011

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 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.


Recruitment information / eligibility

Status Completed
Enrollment 440
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Virosomal influenza vaccine (AdImmune HA Antigen)
Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 µg HA antigen of B/Brisbane/60/2008-like virus
Virosomal influenza vaccine (CSL HA Antigen)
Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 µg HA antigen of B/Brisbane/60/2008-like virus

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 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) 3 weeks after vaccination (Day 22 ± 2 days) No
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) 3 weeks after vaccination (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) 3 weeks after vaccination (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, Tolerability and acceptability
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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