InfluenzaPhase 1NCT01617239
Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine
A Phase 1 study testing Virosomal influenza vaccine in people with Influenza, run by Crucell Holland BV at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Virosomal influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2012to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Employee at the investigational site or relative of the investigator
- Subjects who in the view of investigator will not comply with study procedure and/or visit requirements as per protocol
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Center for the Evaluation of Vaccination, Unit of Epidemiology and Social Medicine, University of Antwerp
Antwerp, 2610
About this study
Official title: A Phase I, Open Label, Randomized Study in Healthy Adults to Compare Safety and Immunogenicity of Different Administration Schedules of Virosomal Influenza Vaccine
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.
Read the detailed description
Virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 mL dose. The aim of this study is to evaluate the safety and immunogenicity of different doses and vaccination schedules. A total of 84 healthy adults aged 18-50 years will be randomized (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 mL) at Days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 mL) at Day 1 and a standard dose (0.5 mL) at Day 57; subjects of group 3 will receive a triple dose (0.5 mL) at Day 1. Local and systemic solicited adverse events up to Day 4 after each vaccination will be documented. To assess the subjects' humoral and cellular immune response against homologous and heterologous virus strains, blood will be drawn from each participant at baseline (Day 1), at the 4 subsequent monthly visits (Months 1 to 4) and at Month 12.
- Conditions
- Influenza
- Being tested
- Virosomal influenza vaccine
- Keywords
- Influenza, Vaccination, Virosomal influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virosomal influenza vaccineBiological
Also called Inflexal V
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)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 1 x standard dose (0.5 mL) on Day 1, Day 29, and Day 57 Receives: 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. Receives: Biological: Virosomal influenza vaccine |
| Group 3 | Experimental | 1 x triple standard dose (1.5 mL) on Day 1 Receives: Biological: Virosomal influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local and systemic solicited adverse events
Measured: 4 days after each vaccination (day of vaccination and the followoing 3 days)
Secondary outcomes (3)
Incidence of unsolicited AEs
Measured: 4 weeks after each vaccination
Humoral and cellular immune response against homologous and heterologous vaccine strains
Measured: Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination
Incidence of SAEs
Measured: up to 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enza di Modugno, Study director, Crucell Holland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617239
- Sponsor's protocol ID
- INF-V-A017
- Other IDs
- 2012-001693-28
- Status last verified
- Aug 2014
- First submitted
- 10 May 2012
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Randomized Study in Healthy Adults to Compare Safety and Immunogenicity of Different Administration Schedules of Virosomal Influenza Vaccine
- ClinicalTrials.gov ID
- NCT01617239
- Acronym / sponsor ID
- INF-V-A017
- Conditions
- Influenza
- Keywords
- Influenza, Vaccination, Virosomal influenza vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 mL dose. The aim of this study is to evaluate the safety and immunogenicity of different doses and vaccination schedules. A total of 84 healthy adults aged 18-50 years will be randomized (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 mL) at Days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 mL) at Day 1 and a standard dose (0.5 mL) at Day 57; subjects of group 3 will receive a triple dose (0.5 mL) at Day 1. Local and systemic solicited adverse events up to Day 4 after each vaccination will be documented. To assess the subjects' humoral and cellular immune response against homologous and heterologous virus strains, blood will be drawn from each participant at baseline (Day 1), at the 4 subsequent monthly visits (Months 1 to 4) and at Month 12.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Virosomal influenza vaccine1 x standard dose (0.5 mL) on Day 1, Day 29, and Day 57 |
| Group 2 | Experimental | Biological: Virosomal influenza vaccine1 x double standard dose (1.0 mL) on Day 1 and 1 x standard dose (0.5 mL) on Day 57. |
| Group 3 | Experimental | Biological: Virosomal influenza vaccine1 x triple standard dose (1.5 mL) on Day 1 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virosomal influenza vaccineAlso: Inflexal VVirosomal 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) | Biological | Group 1, Group 2, Group 3 |
Primary outcome
Incidence of local and systemic solicited adverse events
Time frame: 4 days after each vaccination (day of vaccination and the followoing 3 days)
3 secondary outcomes
Incidence of unsolicited AEs
Time frame: 4 weeks after each vaccination
Humoral and cellular immune response against homologous and heterologous vaccine strains
Time frame: Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination
Incidence of SAEs
Time frame: up to 12 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enza di Modugno study director
Crucell Holland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Virosomal influenza vaccine in people with Influenza, run by Crucell Holland BV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of local and systemic solicited adverse events (time frame: 4 days after each vaccination (day of vaccination and the followoing 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.