Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers

Influenza Clinical Trial

Official title:

Randomized, Parallel-group, Double-blind, Single-center Phase III Study to Assess the Immunogenicity and Safety of the 2011/2012-season Influenza Vaccine Formulated With HA Antigen From Two Suppliers, in Elderly and Young Adult Subjects Using the Current EMA Regulations as Guideline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412281
• Other study ID #: ADD-V-A002
• 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

• Influenza
• Influenza, Human

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