InfluenzaPhase 1NCT02148328
Safety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults
A Phase 1 study testing Trivalent virosomal influenza vaccine, Commercial vaccine 1 and Quadrivalent virosomal influenza vaccine in people with Influenza, run by Crucell Holland BV at 4 sites in Belgium.
Trial summary
The purpose of this study is to examine the safety and tolerability after administration of trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Trivalent virosomal influenza vaccine, Commercial vaccine 1 and Quadrivalent virosomal influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesBelgium
- Study dates
- May 2014to Oct 2014
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female adults
- Body Mass Index <= 30 kilogram per square meter (kg/m^2)
- Written informed consent
Who cannot join
- Vaccination with 2013/2014-seasonal influenza vaccine and/or receipt of any vaccine in the 4 weeks preceding receipt of study vaccine and/or any vaccination planned within 3 weeks from the study vaccine
- Diagnosis (by rapid test, performed at clinic/hospital laboratory) of laboratory-confirmed influenza in the 2013/2014 season
- Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
- Acute febrile illness (greater than or equal to 38.0 celcius)
- Pregnancy as assessed by urine pregnancy test before vaccination, or lactation. Women of childbearing potential (that is, not surgically sterilized/hysterectomized or post-menopausal for more than 2 years) will be excluded if one of the following criteria is met: 1). Intention to become pregnant during the course of the study or to donate eggs (ova, oocytes) for the purposes of assisted reproduction 2). If heterosexually active, not using or not willing to continue using a medically reliable method of contraception for the entire study duration (up to 90 days). A medically reliable method of contraception includes oral contraceptive preparation (for example pills), hormonal implant, progestative injection, patch contraceptive formulation, an intrauterine device, concomitant use of barrier method and spermicide, or another method considered sufficiently reliable by the investigator in individual cases
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Study site
Aalst
Study site
Ghent
Study site
Merksem
Study site
Wilrijk
About this study
Official title: A Phase 1, Double-blind, Active-controlled, Randomized Study in Healthy Adults to Evaluate Safety, Tolerability, and Immunogenicity of a Trivalent and Quadrivalent Cell-based Virosomal Subunit Influenza Vaccine
The purpose of this study is to examine the safety and tolerability after administration of trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.
Read the detailed description
This is a double-blind and randomized study in healthy adults. The duration of study will be approximately 90 days per participant. The study will include 4 visits: Day 1 (for vaccination), Day 4, Day 22 and day 90 (Follow-up visits). Safety and tolerability will be assessed by the rate of solicited, unsolicited, and serious adverse events.
- Conditions
- Influenza
- Being tested
- Trivalent virosomal influenza vaccine, Commercial vaccine 1, Quadrivalent virosomal influenza vaccine, Commercial vaccine 2
- Keywords
- Healthy participants, Immunogenicity, Influenza, Prevention, Safety
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent virosomal influenza vaccineBiological
Also called Trivalent FluCell
Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Commercial vaccine 1Biological
Also called Inflexal V (trivalent)
Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Quadrivalent virosomal influenza vaccineBiological
Also called Quadrivalent FluCell
Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Commercial vaccine 2Biological
Also called Fluarix Tetra (quadrivalent)
Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
| Study group | Role | What they receive |
|---|---|---|
| Trivalent virosomal influenza vaccine | Experimental | Trivalent virosomal influenza vaccine will be administered intramuscularly (injection of a substance into a muscle) on Day 1 in healthy participants. Receives: Biological: Trivalent virosomal influenza vaccine |
| Commercial vaccine 1 | Active comparator | Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. Receives: Biological: Commercial vaccine 1 |
| Quadrivalent virosomal influenza vaccine | Experimental | Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. Receives: Biological: Quadrivalent virosomal influenza vaccine |
| Commercial vaccine 2 | Active comparator | Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. Receives: Biological: Commercial vaccine 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Solicited Local Adverse Events (AEs)
The local AEs pain, erythema, and induration at the study vaccine injection site will be noted in the participant Diary from Day 1 to Day 8. The extent (largest diameter) of any redness or induration should be measured daily and recorded, along with any functional limitation of activity. Local AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
Measured: Up to Day 8
Number of participants with Solicited Systemic Adverse Events (AEs)
The solicited systemic AEs headache, fatigue, myalgia, malaise, and shivering/rigors will be noted in the participant Diary from Day 1 to Day 8. Fever (defined as body temperature greater than 38.0 Celsius) is another solicited systemic AE. Local AEs will be graded according to severity as mild (grade 1), moderate (grade 2), severe (grade 3) and potentially life threatening (grade 4).
Measured: Up to Day 8
Number of participants with Unsolicited Adverse Events (AEs)
Unsolicited AEs are all AEs the participants are not specifically asked about in the participant Diary.
Measured: Up to Day 22
Number of participants with Serious Adverse Events (SAEs)
The SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization or is a suspected transmission of any infectious agent via medicinal product.
Measured: Up to Day 90
Secondary outcomes (3)
Number of Participants with Seroconversion
Number of participants with seroconversion will be the participants with a greater than or equal to (>=) 4-fold increase in hemagglutination inhibition (HI) antibody titer and a titer of >=1:40 at Day 22. HI against homologous strains will be measured with the HI test in serum.
Measured: Day 22
Number of Participants with Seroprotection
Number of participants with seroprotection is defined as number of participants with HI antibody >=1:40 at Day 22. HI against homologous strains will be measured with the HI test in serum.
Measured: Baseline and Day 22
Change From Baseline in Geometric Mean Titer (GMT) of HI antibodies
GMT and increase in GMT of HI antibodies from Baseline to Day 22 will be assessed.
Measured: Baseline and Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionOct 2014
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Crucell Holland BV Clinical Trial, Study director, Crucell Holland BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148328
- Sponsor's protocol ID
- CR104114
- Other IDs
- FLUCELLFLZ1003, 2014-000573-39, 2014
- Status last verified
- Oct 2014
- First submitted
- 23 May 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Active-controlled, Randomized Study in Healthy Adults to Evaluate Safety, Tolerability, and Immunogenicity of a Trivalent and Quadrivalent Cell-based Virosomal Subunit Influenza Vaccine
- ClinicalTrials.gov ID
- NCT02148328
- Acronym / sponsor ID
- CR104114
- Conditions
- Influenza
- Keywords
- Healthy participants, Immunogenicity, Influenza, Prevention, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 May 2014 (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 purpose of this study is to examine the safety and tolerability after administration of trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.
Detailed description
This is a double-blind and randomized study in healthy adults. The duration of study will be approximately 90 days per participant. The study will include 4 visits: Day 1 (for vaccination), Day 4, Day 22 and day 90 (Follow-up visits). Safety and tolerability will be assessed by the rate of solicited, unsolicited, and serious adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trivalent virosomal influenza vaccine | Experimental | Biological: Trivalent virosomal influenza vaccineTrivalent virosomal influenza vaccine will be administered intramuscularly (injection of a substance into a muscle) on Day 1 in healthy participants. |
| Commercial vaccine 1 | Active comparator | Biological: Commercial vaccine 1Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. |
| Quadrivalent virosomal influenza vaccine | Experimental | Biological: Quadrivalent virosomal influenza vaccineQuadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. |
| Commercial vaccine 2 | Active comparator | Biological: Commercial vaccine 2Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female adults
- Body Mass Index <= 30 kilogram per square meter (kg/m^2)
- Written informed consent
Key exclusion criteria (5 listed)
- Vaccination with 2013/2014-seasonal influenza vaccine and/or receipt of any vaccine in the 4 weeks preceding receipt of study vaccine and/or any vaccination planned within 3 weeks from the study vaccine
- Diagnosis (by rapid test, performed at clinic/hospital laboratory) of laboratory-confirmed influenza in the 2013/2014 season
- Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
- Acute febrile illness (greater than or equal to 38.0 celcius)
- Pregnancy as assessed by urine pregnancy test before vaccination, or lactation. Women of childbearing potential (that is, not surgically sterilized/hysterectomized or post-menopausal for more than 2 years) will be excluded if one of the following criteria is met: 1). Intention to become pregnant during the course of the study or to donate eggs (ova, oocytes) for the purposes of assisted reproduction 2). If heterosexually active, not using or not willing to continue using a medically reliable method of contraception for the entire study duration (up to 90 days). A medically reliable method of contraception includes oral contraceptive preparation (for example pills), hormonal implant, progestative injection, patch contraceptive formulation, an intrauterine device, concomitant use of barrier method and spermicide, or another method considered sufficiently reliable by the investigator in individual cases
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 |
|---|---|---|
| Trivalent virosomal influenza vaccineAlso: Trivalent FluCellTrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. | Biological | Trivalent virosomal influenza vaccine |
| Commercial vaccine 1Also: Inflexal V (trivalent)Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. | Biological | Commercial vaccine 1 |
| Quadrivalent virosomal influenza vaccineAlso: Quadrivalent FluCellQuadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. | Biological | Quadrivalent virosomal influenza vaccine |
| Commercial vaccine 2Also: Fluarix Tetra (quadrivalent)Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. | Biological | Commercial vaccine 2 |
Primary outcome
Number of participants with Solicited Local Adverse Events (AEs)
Time frame: Up to Day 8
The local AEs pain, erythema, and induration at the study vaccine injection site will be noted in the participant Diary from Day 1 to Day 8. The extent (largest diameter) of any redness or induration should be measured daily and recorded, along with any functional limitation of activity. Local AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
Number of participants with Solicited Systemic Adverse Events (AEs)
Time frame: Up to Day 8
The solicited systemic AEs headache, fatigue, myalgia, malaise, and shivering/rigors will be noted in the participant Diary from Day 1 to Day 8. Fever (defined as body temperature greater than 38.0 Celsius) is another solicited systemic AE. Local AEs will be graded according to severity as mild (grade 1), moderate (grade 2), severe (grade 3) and potentially life threatening (grade 4).
Number of participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 22
Unsolicited AEs are all AEs the participants are not specifically asked about in the participant Diary.
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 90
The SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization or is a suspected transmission of any infectious agent via medicinal product.
3 secondary outcomes
Number of Participants with Seroconversion
Time frame: Day 22
Number of Participants with Seroprotection
Time frame: Baseline and Day 22
Change From Baseline in Geometric Mean Titer (GMT) of HI antibodies
Time frame: Baseline and Day 22
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 24 Oct 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.
Crucell Holland BV Clinical Trial study director
Crucell Holland BV
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trivalent virosomal influenza vaccine, Commercial vaccine 1 and Quadrivalent virosomal influenza vaccine in people with Influenza, run by Crucell Holland BV at 4 sites 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 3 inclusion and 5 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 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Number of participants with Solicited Local Adverse Events (AEs) (time frame: Up to Day 8). The study lists 4 primary outcomes in all. 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 24 Oct 2014.