Re-licensing Study to Assess Virosomal Influenza Vaccine Formulated With WHO Recommended Influenza Strains

Influenza Clinical Trial

Official title:

Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2012/2013-Season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01631071
• Other study ID #: ADD-V-A003
• Status: Completed
• Phase: N/A
• First received: June 25, 2012
• Last updated: December 19, 2013
• Start date: July 2012
• Est. completion date: August 2012

Study information

• Verified date: February 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 virosomal influenza vaccine 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) starting from the first day of the month following the last visit in a previous study

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Virosomal influenza vaccine
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL virosomal influenza vaccine

Locations

Country	Name	City	State
Switzerland	CROSS-Research SA	Arzo

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