NCT01617239

Brief Summary

The goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

May 10, 2012

Last Update Submit

August 19, 2014

Conditions

Influenza

Keywords

InfluenzaVaccinationVirosomal influenza vaccine

Outcome Measures

Primary Outcomes (1)

  • Incidence of local and systemic solicited adverse events

    4 days after each vaccination (day of vaccination and the followoing 3 days)

Secondary Outcomes (3)

  • Incidence of unsolicited AEs

    4 weeks after each vaccination

  • Humoral and cellular immune response against homologous and heterologous vaccine strains

    Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination

  • Incidence of SAEs

    up to 12 months after baseline

Study Arms (3)

Group 1

EXPERIMENTAL

1 x standard dose (0.5 mL) on Day 1, Day 29, and Day 57

Biological: Virosomal influenza vaccine

Group 2

EXPERIMENTAL

1 x double standard dose (1.0 mL) on Day 1 and 1 x standard dose (0.5 mL) on Day 57.

Biological: Virosomal influenza vaccine

Group 3

EXPERIMENTAL

1 x triple standard dose (1.5 mL) on Day 1

Biological: Virosomal influenza vaccine

Interventions

Virosomal influenza vaccineBIOLOGICAL

Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012: * 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 Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)

Also known as: Inflexal V
Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female adults
  • Aged ≥ 18 to ≤ 50 years on the day of enrollment
  • 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

You may not qualify if:

  • Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
  • Body weight below 40 kg at any visit during the study
  • Acute febrile illness (≥ 38.0°C)
  • Known hypersensitivity to any vaccine component
  • Previous history of a serious adverse reaction to influenza vaccine
  • Previous vaccination with a seasonal influenza vaccine for season 2011-2012 or a virosomal formulation of seasonal influenza vaccine in any season
  • 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) or cancer
  • Known history of psychiatric diseases, particularly dementia
  • 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 for the entire duration of this trial
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for the Evaluation of Vaccination, Unit of Epidemiology and Social Medicine, University of Antwerp

Antwerp, 2610, Belgium

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Inflexal V

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Enza di Modugno

    Crucell Holland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2012

First Posted

June 12, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

BE(1)