A Study to Assess Immunogenicity Parameters After Vaccination Against Influenza and to Evaluate How These Parameters Change During the Influenza Season

Influenza Clinical Trial

Official title:

A Phase IV, Open Label Study to Evaluate the Short and Long Term Immune Response and CROSS-protection After Vaccination With viroSOME Adjuvanted Inflexal V in Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457027
• Other study ID #: INF-V-A007
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2011
• Last updated: February 19, 2013
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2013
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection against 4 selected circulating heterogeneous A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Healthy female and male adults aged >60 years on the day of enrollment

• Written informed consent

• Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause)

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 for season 2011/2012

• 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/day prednisolone or equivalent (inhaled or topical steroids are allowed)

• Known immunodeficiency (including leukemia, HIV seropositivity) or 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)

• Participation in another clinical trial

• Employee at the investigational site or relative of the investigator

• Anticipated non-compliance with study procedures

Study Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Inflexal V
Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2011-2012 season, containing per 0.5 mL dose: 15 µg hemagglutinin (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 Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1

Locations

Country	Name	City	State
Italy	Dept. of Health Sciences, University of Genoa and Hygiene Unit, "San Martino" University Hospital	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

Italy, 

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 will be 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 will be 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	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 will be 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	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 will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)	6 months post-vaccination	No
Secondary	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 will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)	6 months post-vaccination	No
Secondary	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 will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)	6 months post-vaccination	No