search
Back to results

Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Inflexal V
Sponsored by
Crucell Holland BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Virus, Vaccination, Inflexal V

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Covance Clinical Research Unit AG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Elderly subjects aged over 60 years

Adults from 18 to 60 years old inclusive

Arm Description

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
June 25, 2012
Last Updated
December 19, 2013
Sponsor
Crucell Holland BV
search

1. Study Identification

Unique Protocol Identification Number
NCT01631110
Brief Title
Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains
Official Title
Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2012/2013-Season Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crucell Holland BV

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Virus, Vaccination, Inflexal V

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elderly subjects aged over 60 years
Arm Type
Experimental
Arm Title
Adults from 18 to 60 years old inclusive
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Inflexal V
Other Intervention Name(s)
Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2012-2013 season, each 0.5 mL dose containing:, • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus, • 15 µg HA antigen of A/Victoria/361/2011 (H3N2)-like virus, • 15 µg HA antigen of B/Wisconsin/1/2010-like virus
Intervention Description
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
Primary Outcome Measure Information:
Title
Seroprotection
Description
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)
Time Frame
Day 22 +/- 2 days
Title
Seroconversion
Description
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)
Time Frame
Day 22 +/- 2 days
Title
Geometric Mean Titer
Description
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)
Time Frame
Day 22 +/- 2 days
Secondary Outcome Measure Information:
Title
Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability
Description
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
Time Frame
Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Seiberling, MD
Organizational Affiliation
Covance Clinical Research Unit AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Covance Clinical Research Unit AG
City
Allschwil
ZIP/Postal Code
4123
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains

We'll reach out to this number within 24 hrs